I didn’t really fit into the company I was in before, so firstly, I think to enjoy any role the people you work with are important. Realistically, I probably spend more time speaking with my colleagues than I do my own wife and kids, so having great colleagues definitely makes Scimcon enjoyable.
Secondly, the challenges within the role are exciting. Whenever you start a new contract – as we do regularly, supporting clients in pharma and biopharma – there is either an implementation project that needs carrying out, or an issue that needs resolving. Sometimes, the task at hand is not something I am directly familiar with or have the exact experience doing, but that makes it a challenge. And it’s the challenge that I enjoy.
In my prior role, we partnered with Scimcon on a number of projects. I had been involved in building a platform for our mutual client and when they needed to take the project forward, they needed someone to train, support, and project manage the implementation of the project software. It seemed a no-brainer for me to join the consultancy team at Scimcon, and to continue to support the project and the client to help them to progress. The transition into Scimcon was seamless, and I later moved from that initial project within the vaccines space onto a biotech company in the Netherlands, whom I have been supporting on e-systems.
My background helps me to bring people and team skills into play, so I am very suited to the Scimcon way of working, to support clients and to manage processes, SOPs, digital, and software projects for scientific companies. The client I am supporting currently was initially reluctant to appoint a lab informatics consultancy that was not local, and questions were raised as to whether or not we could perform the role from the UK without impacting the level of support we provide. As a test run, we were initially only working on a 3-month contract. Their processes are crucial to the business scale-up and growth, and our experience with other big pharma organisations has come into play helping them to navigate the decisions needed. I think we successfully demonstrated to them that it is feasible to be productive offering great support from the UK – so much so that the original 3-month project is now 30 months.
Every child has a hobby growing up, and of course in England, playing sports is probably one of the most popular activities. For me, football was my favourite pastime which evolved into more than just a hobby. It actually paved a pathway for all areas of my life.
What started out as a recreational game became a profession, as I left school at 16 to become a full-time football player, At 20, when my professional playing career finished, football again opened a window of opportunity to move to Southern California and coach football for 3 months. I returned 12 years later!
At 27, football again paid for my University education at Point Loma Nazarene University in San Diego, where I was sponsored via a soccer scholarship to study Business and Finance. I had never even enjoyed school, never mind imagined studying at University, but football provided a unique opportunity that was too good to refuse.
During my senior year at University, while coaching football in Denver during the summer, I was introduced to my fiancé Sarah who had also – coincidentally – attended University in the USA on a football scholarship. She was almost in a parallel to me, only she was based in Florida while I was on the total opposite side of the country in California.
Sarah and I had our first child then returned to the UK shortly after, where we now have four sons – aged 10, 7, 5, and 1. Our 10 and 7-year-olds are, like their mum and dad, football-mad, so we spend our weekends travelling to watch them play. Our 5-year-old is starting to get the bug, and we are yet to see if football is something our youngest warms to, but I can’t see the apple falling too far from the tree.
I still spend every day at some sort of football activity. Both our older boys are at the football academies so they each have 3-4 days a week training and playing. Football remains our outside-of-work life, having brought us together all those years ago.
And with the skills I learned at university, studying business and finance, as well as the team skills associated with playing sport, I am well placed to bring team leadership to the Scimcon family, and to focus on the best tactics and teams to work on a winning side.
Southern California was my home for 12 years, and having attended University in San Diego, that would be my obvious choice. We have a lot of friends and happy memories there, and we love the area – and the food!
We made the decision to return to UK as a family when we had the boys, for the support network of close family and friends. As I have been working from home for so many years anyway, personally my life hardly changed. However, it was a terrible impact for the boys. For any young kids, that transitional age and loss of companionship has been a huge negative experience. Luckily, the boys are pretty resilient and seemed to have bounced back into the new normal without any issues.
Funnily enough, I am not really a techie! I use a PC and a phone, but not much else.
Even though I don’t spend a great deal of time on gadgets and gizmos, I love the knowledge and benefits you can see from technology. For example, having spent so many of my formative years playing and coaching football, I am now still involved with my sons and their training and I see the technology to hand, which was never available when I was playing in the US. It’s absolutely fascinating, and there’s two pieces of tech in particular that I’m seeing used regularly at my sons’ training and matches. One is a Veo sports camera, which follows the ball and records the play, the other is an APEX GPS tag. This handy piece of kit is worn in the back of my son’s shirt when he’s playing, and all the data collected throughout the match is recorded on a smartphone, recording metrics such as speed, average position, and provides an overall performance review.
It’s amazing to see two of my previously completely separate worlds – football and technology – coming together, and it is really interesting to see how this technology is enabling football. As a coach, it also allows me to see and read the data available, so that we can then determine what is needed to improve in a game.
Scimcon is not a technology company, it is a people company that helps to solve the technology challenges for our clients, whether they be implementation, process or project-related. I am happy that I am not a techie, but very much a team and a people-person who can always learn and bring new skills to the table.Industry leader interviews: Mark Elsley?
I am Mark Elsley, a Senior Clinical Research / Data Management Executive with 30 years’ experience working within the pharmaceutical sector worldwide for companies including IQVIA, Boehringer Ingelheim, Novo Nordisk and GSK Vaccines. I am skilled in leading multi-disciplinary teams on projects through full lifecycles to conduct a breadth of clinical studies including Real World Evidence (RWE) research. My specialist area of expertise is in clinical data management, and I have published a book on this topic called “A Guide to GCP for Clinical Data Management” which is published by Brookwood Global.
Data quality is a passion of mine and now receives a lot of focus from the regulators, especially since the updated requirements for source data in the latest revision of ICH-GCP. It is a concept which is often ill-understood, leading to organisations continuing to collect poor quality data whilst risking their potential rejection by the regulators.
White and Gonzalez1 created a data quality equation which I think is a really good definition: They suggested that Data Quality = Data Integrity + Data Management. Data integrity is made up of many components. In the new version of ICH-GCP it states that source data should be attributable, legible, contemporaneous, original, accurate, and complete. The Data Management part of the equation refers to the people who work with the data, the systems they use and the processes they follow. Put simply, staff working with clinical data must be qualified and trained on the systems and processes, processes must be clearly documented in SOPs and systems must be validated. Everyone working in clinical research must have a data focus… Data management is not just for data managers!
By adopting effective strategies to maximise data quality, the variability of the data are reduced. This means study teams will need to enrol fewer patients because of sufficient statistical power (which also has a knock-on impact on the cost of managing trials).2 Fewer participants also leads to quicker conclusions being drawn, which ultimately allows new therapies to reach patients sooner.
I believe that clinical trials data are vitally important. These assets are the sole attribute that regulators use to decide whether to approve a marketing authorization application or not, which ultimately allows us to improve patient outcomes by getting new, effective drugs to market faster. For a pharmaceutical company, the success of clinical trial data can influence the stock price and hence the value of a pharmaceutical company3 by billions of dollars. On average, positive trials will lead to a 9.4% increase while negative trials contribute to a 4.5% decrease. The cost of managing clinical trials amounts to a median cost per patient of US$ 41,4134 or US$ 69 per data point (based on 599 data points per patient).5. In short, clinical data have a huge impact on the economics of the pharmaceutical industry.
Healthcare organizations generate and use immense amounts of data, and use of good study data can go on to significantly reduce healthcare costs 6, 7. Capturing, sharing, and storing vast amounts of healthcare data and transactions, as well as the expeditious processing of big data tools, have transformed the healthcare industry by improving patient outcomes while reducing costs. Data quality is not just a nice-to-have – the prioritization of high-quality data should be the emphasis for any healthcare organization.
However, when data quality is not seen as a top priority in health organizations, subsequently large negative impacts can be seen. For example, Public Health England recently reported that nearly 16,000 coronavirus cases went unreported in England. When outputs such as this are unreliable, guesswork and risk in decision making are heightened. This exemplifies that the better the data quality, the more confidence users will have in the outputs they produce, lowering risk in the outcomes, and increasing efficiency.
ICH-GCP8 for interventional studies and GPP9 for non-interventional studies contain many requirements with respect to clinical data so a thorough understanding of those is essential. It is impossible to achieve 100% data quality so a risk-based approach will help you decide which areas to focus on. The most important data in a clinical trial are patient safety and primary end point data so the study team should consider the risks to these data in detail. For example, for adverse event data, one of the risks to consider could include the recall period of the patient if they visit the site infrequently. A patient is unlikely to have a detailed recollection of a minor event that happened a month ago. Collection of symptoms via an electronic diary could significantly decrease the risk and improve the data quality in this example. Risks should be routinely reviewed and updated as needed. By following the guidelines and adopting a risk-based approach to data collection and management, you can be sure that analysis of the key parameters of the study is robust and trust-worthy.
Aside from the risk-based approach which I mentioned before, another area which I feel is important is to only collect the data you need; anything more is a waste of money, and results in delays getting drugs to patients. If you over-burden sites and clinical research teams with huge volumes of data this increases the risks of mistakes. I still see many studies where data are collected but are never analysed. It is better to only collect the data you need and dedicate the time saved towards increasing the quality of that smaller dataset.
Did you know that:
In 2016, the FDA published guidance12 for late stage/post approval studies, stating that excessive safety data collection may discourage the conduct of these types of trials by increasing the resources needed to perform them and could be a disincentive to investigator and patient participation in clinical trials.
The guidance also stated that selective safety data collection may facilitate the conduct of larger trials without compromising the integrity and the validity of trial results. It also has the potential to facilitate investigators and patients’ participation in clinical trials and help contain costs by making more-efficient use of clinical trial resources.
Technology, such as Electronic Health Records (HER) and electronic patient reported outcomes (ePRO), drug safety systems and other digital-based emerging technologies are currently being used in many areas of healthcare. Technology such as these can increase data quality but simultaneously increase the number of factors involved. It impacts costs, involves the management of vendors and adds to the compliance burden, especially in the areas of vendor qualification, system validation, and transfer validation.
I may be biased as my job title includes the word ‘Data’ but I firmly believe that data are the most important assets in clinical research, and I have data to prove it!
Scimcon is proud to support clients around the globe with managing data at its highest quality. For more information, contact us.
1White, Christopher H., and Lizzandra Rivrea González. “The Data Quality Equation—A Pragmatic Approach to Data Integrity.” Www.Ivtnetwork.Com, 17 Aug. 2015, www.ivtnetwork.com/article/data-quality-equation%E2%80%94-pragmatic-approach-data-integrity#:~:text=Data%20quality%20may%20be%20explained. Accessed 25 Sept. 2020.
2Alsumidaie, Moe, and Artem Andrianov. “How Do We Define Clinical Trial Data Quality If No Guidelines Exist?” Applied Clinical Trials Online, 19 May 2015, www.appliedclinicaltrialsonline.com/view/how-do-we-define-clinical-trial-data-quality-if-no-guidelines-exist. Accessed 26 Sept. 2020.
3Rothenstein, Jeffrey & Tomlinson, George & Tannock, Ian & Detsky, Allan. (2011). Company Stock Prices Before and After Public Announcements Related to Oncology Drugs. Journal of the National Cancer Institute. 103. 1507-12. 10.1093/jnci/djr338.
4Moore, T. J., Heyward, J., Anderson, G., & Alexander, G. C. (2020). Variation in the estimated costs of pivotal clinical benefit trials supporting the US approval of new therapeutic agents, 2015-2017: a cross-sectional study. BMJ open, 10(6), e038863. https://doi.org/10.1136/bmjopen-2020-038863
5O’Leary E, Seow H, Julian J, Levine M, Pond GR. Data collection in cancer clinical trials: Too much of a good thing? Clin Trials. 2013 Aug;10(4):624-32. doi: 10.1177/1740774513491337. PMID: 23785066.
6Khunti K, Alsifri S, Aronson R, et al. Rates and predictors of hypoglycaemia in 27 585 people from 24 countries with insulin-treated type 1 and type 2 diabetes: the global HAT study. Diabetes Obes Metab. 2016;18(9):907-915. doi:10.1111/dom.12689
7Evans M, Moes RGJ, Pedersen KS, Gundgaard J, Pieber TR. Cost-Effectiveness of Insulin Degludec Versus Insulin Glargine U300 in the Netherlands: Evidence From a Randomised Controlled Trial. Adv Ther. 2020;37(5):2413-2426. doi:10.1007/s12325-020-01332-y
8Ema.europa.eu. 2016. Guideline for good clinical practice E6(R2). [online] Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-6-r2-guideline-good-clinical-practice-step-5_en.pdf [Accessed 10 May 2021].
9Pharmacoepi.org. 2020. Guidelines For Good Pharmacoepidemiology Practices (GPP) – International Society For Pharmacoepidemiology. [online] Available at: https://www.pharmacoepi.org/resources/policies/guidelines-08027/ [Accessed 31 October 2020].
10Medical Device Innovation Consortium. Medical Device Innovation Consortium Project Report: Excessive Data Collection in Medical Device Clinical Trials. 19 Aug. 2016. https://mdic.org/wp-content/uploads/2016/06/MDIC-Excessive-Data-Collection-in-Clinical-Trials-report.pdf
11O’Leary E, Seow H, Julian J, Levine M, Pond GR. Data collection in cancer clinical trials: Too much of a good thing? Clin Trials. 2013 Aug;10(4):624-32. doi: 10.1177/1740774513491337. PMID: 23785066.
12FDA. Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations Guidance for Industry. Feb. 2016.Meet Scimcon: Geoff Parker?
That’s an easy question, I love the constantly changing challenges that informatics consultancy throws up and helping customers and our own internal teams to creatively meet those challenges.
We help customers in pharma, biopharma, and clinical trials to identify and evaluate the goals and challenges ahead and use this to influence information system strategies. We assist with programme and project direction; vendor and product selection (of LIMS, SDMS, ELNs and ePRO solutions); and to drive successful software implementations.
The works is often equal parts frustrating, challenging, and exciting but as people who have been involved in this type of work will recognise, it is ultimately extremely rewarding.
I am somewhat cursed by having multiple passions to fit into my spare time. Being a keen mountain biker, avid photographer and relentless traveller does present some time-management dilemmas.
Photography is something I have been fascinated by since I was at school, and is something that I have picked up and put down intermittently since then. However, three years ago I was lucky enough to spend a week riding bikes with a professional photographer and this really inspired me to develop my skills and style. You can view some of my results of my photography journey on my portfolio site.
My addiction to mountain biking started when I moved to Scotland ten years ago, as there is some of the best riding in the world, right here. The mixture of physical demands, technical riding skills and the pure pleasure of being surrounded by forest and mountains has proved irresistible. Not that the abundance of local riding has stopped me traveling with my bike. Ten years of truly amazing riding has taken me to some of the best trails in Morocco, Nepal, USA, New Zealand, Switzerland, Norway, Iceland, and Chile! Like most people, I am looking forward to when travel once again becomes possible, then maybe I can put my planned trips to Kyrgyzstan and Bhutan into action.
I’m not sure I can pick a favourite, as it depends on the activity involved. For a chilled afternoon walk drinking coffee, I would have to say San Francisco. Relaxed attitude, wide open streets and great culture make it a hard place to beat.
For mountain biking, it could be any of those places I mentioned above. My trip spending a week on HMS Gassten, a converted World War Two minesweeper, with a group of good friends riding high above the fjords in Norway deserves special mention. Also, I think Nepal’s Mustang Valley was a special trip. Amazing culture, fantastic people, and as for those mountains – they build them big over there!
The biggest difference is that I have been at home for the longest period in about 22 years! In the last 12 months, I have only managed to travel down to our office in Newmarket twice (from my home in Scotland). I would normally travel 2 or 3 weeks out of 4, so it has been a big change.
Distancing from family and friends has also been difficult, as it has for most. I have stayed in touch as much as possible with family and friends the same way anyone else has; telephone calls, meeting in car parks and standing 4 metres apart, in addition to several Zoom quizzes!
I have had a long fascination with technology, which of course in part has led to my role at Scimcon. We have obviously come a long way since I first became involved in technology. I started programming on home computers during the explosion of affordable devices in the UK during the early 1980s.
Everything has continued to stem from there, to a point where I’m now the co-founder of a scientific technology consultancy, using technology to drive change and deliver scientific value.
In terms of devices, I use pretty much anything you can imagine. I have electronic shifting on a couple of my bikes, and I have some amazing camera equipment that even five years ago would have been inconceivable.
I don’t think my use of technology in my everyday is too different to how I would use it at work. At Scimcon we try to use technology in a way that enhances people’s work lives, so that they can focus on what is important. If I look at technology in bikes and cameras, what excites me is the same thing – not the technology itself, but what it allows you to do.
For example, when I started photography at school, the process was incredibly different to how it is now. You tried different methods of taking photographs and would be left with a roll of film afterwards that if you were lucky, you’d get developed a week later. Of course, you could guarantee that you would get the photos back after all that time and wonder “what on earth was I trying to do?” Nowadays, we have digital cameras, so you take the photo, see the result, and if it does not work you can just try again instantly.
That’s exactly how we try to use technology at Scimcon. We don’t want technology to get in the way or slow down the result you want to achieve, we want it to enable you to do the work you are trying to do – whether that’s riding bikes, taking photographs, or integrating your LIMS to streamline your workflow.
Prior to joining Scimcon I had worked for large and medium sized corporations. I enjoyed my time in these organisations, but one of the qualities that initially attracted me to Scimcon was the small, close nit team that felt more like a family where every individual really matters to the success of the company. As it is a small company, you cannot hide, sit back and let others do the work for you. Everyone pulls their weight, and we back each other up if we face challenges.
Scimcon has also allowed me to work on a variety of interesting projects in areas I may not have been able to access in my previous roles.
I have always had an interest in photography, but my real passion lies in astrophotography. My degree was in Physics and Astronomy, and I have therefore always had a fascination with the Universe. I like to take photos of the Milky Way, and I have travelled to Lapland and Iceland where I was lucky enough to have been able to get photos of the Aurora Borealis. I also recently took a photo of the Neowise comet over Ely Cathedral. My 9-year-old daughter has recently become interested in photography, so when we get chance to go for a walk in the countryside as a family, we take our cameras and try to get some landscape photos or photos of flowers, birds, and similar.
Something else I do in my spare time is exercise – I would not say it was a hobby, but more of a chore! I exercise for at least an hour a day, six days a week. This consists of two days at my local bootcamp at 6:20am, outside in the cold, dark and often rain in the winter, with an instructor and a team of about 20 other people. The other four days are purely aerobic, either jogging or using the cross trainer. I am a member of my local gym where I used their cross trainer, but due to the lockdown closing all gyms back in March I bought my own, and haven’t been to the gym since.
When I get the opportunity, I like to have a round of golf too. I usually play with my Dad who is a member of his local golf club, however I do not do it very often as 18 holes usually takes up three hours at least. As I do not play too often, I’m not terribly good, but conversely, I’m not terrible.
When we go on holiday we like to travel to interesting places and try to immerse ourselves in the culture. Some of the more interesting places we have been on holiday are; as mentioned above, Lapland and Iceland, but we have also been to Beijing and walked along the Great Wall of China, Istanbul, Malaysia, Singapore. Once COVID-19 is behind us we would like to take the kids to Australia and Japan.
Prior to COVID-19, it was nice to spend time with friends, having a drink and a laugh, however with the changing restrictions it is not something we get to enjoy regularly at the moment. One thing my friends and I enjoyed doing was a games night. Poker, Black-Jack and Trivial Pursuit; it’s very light-hearted, but it brings out the competitive nature in people.
With the restrictions discouraging activities with people outside of your household, we have recently taken up coarse fishing as a family. It is something that we thought would be something fun to do, to get out of the house and enjoy together. We fish on the nearby Great Ouse river and catch fish such as perch, roach and rudd. It is purely something we do for fun, so we always return the fish back to the river.
This question brings a smile to my face as my wife knows only too well how much I like technology, much to her annoyance. Over the years I have added more and more Philips Hue lights to the house, to the point where every room has at least one. We use Alexa to turn lights on and off.
Similarly, we have a number of Sonos speakers around the house which are also controlled through Alexa. I like the idea of having an electronic assistant, I think it reminds me of some scifi films of the 80’s and 90’s.
I use a Macbook and Adobe Lightroom to edit photos and I share them on Instagram (if I think they’re good enough).
My use of technology at home is very different to work. However, I think the skills I learn from setting up a new device or configuring the way it works can be applied to my work. The use of these devices, and the associated interconnectivity in the home setting helps me keep abreast of the latest technology, which has applications within projects at work too
Clearly good cell network or WIFI connectivity is of primary importance when thinking about using ePRO in a clinical study. Sites should conduct a feasibility activity in their local vicinity during the study initiation phase to understand if cell network strengths are good enough for ePRO and if not, if there is likely to be a large population of subjects that have home WIFI. For remote locations with possible issues with either the cell network coverage or even with the availability of electricity, these sites should be reconsidered before a decision is made to use ePRO.
However, even with bad cell network coverage, it is possible to conduct a study with ePRO by ensuring the correct messaging appears to the subjects on the device. All ePRO systems allow the subjects to access and complete their diaries on a daily basis without cell or WIFI connectivity. The data entered by the subject is stored on the device until connectivity is established. There are circumstances where the site may need to be made aware of certain responses in real time in order to maintain subject safety. If connectivity is established and the data is sent in real time, the site staff may receive an alert from the system asking them to contact the participant. In order to ensure participant safety is maintained it is good practice to alert the participant to contact the sites / study doctor if certain responses in the diary are provided, such as if the participant required emergency medical attention.
As mentioned earlier in an earlier instalment, translation is an aspect not typically associated with clinical systems such as EDC. Additionally, because the ePRO devices are in the hands of the participants, the screens, in their local languages, must be submitted to the local ethics committees within the countries that the study is to take place in.
It should not be forgotten that paper PRO is also subject to a translation process. However, the additional complexity with ePRO is the need to apply the translated text to the software in order to generate the questionnaire screens. This involves multiple review and update rounds between the ePRO vendor and the translation vendor which increases time, effort and therefore cost. Once the screens are generated there may be further review rounds during the in-country review between the local sponsor representatives, ePRO vendor and translation vendor. All of these review rounds increase the timescales for an activity that is already time critical.
Often the date for submission to the ethics committee is set during the planning phase of the study by the sponsor study team. If the submission date is missed it could result in a delay to the study start. Consequently, it is important to ensure clear timelines are in place between agreeing the ePRO requirements, which will decide what is displayed on each of the screens, and submitting the screen report to the ethics committees. The ePRO vendor will need to be made aware of these timelines at the earliest opportunity. It can take more than 12 weeks for the completion of the translations resulting in the creation of the finalized screen reports. These timelines are difficult to manage if the process includes an in-country review round which allows for local country representatives from the sponsor to review the translations. It is important to make clear to the reviewers what it is that these stakeholders are reviewing. Translation is not an exact science. There are many ways of writing the same sentence. As the translator is the trained expert in translations it should be left to them to choose the most appropriate wording in the local language which most faithfully represents the English version. The in-country review, if indeed one is required, should only be conducted to ensure the correct screens are displayed in the screen reports. Allowing the in-country reviewer to make suggestions on preferred wording risks multiple back and forth review rounds, increasing timelines and jeopardizing study start dates.
As briefly mentioned in part one of this series, possibly the most crucial aspect when introducing a new system or process to a user base is change management. If you do not bring your users along the journey with you, you are less likely to gain their acceptance.
How does this manifest itself? With ePRO there is plenty of opportunity for issues to arise, from delays in getting devices to sites, to errors in the software, to usability and connectivity issues. All of which can affect the investigators ability to get on with their daily work. If you have not put in place a good change management process you will find the investigators very quickly become disenchanted with the system and even the smallest of issues will become magnified, resulting in escalations to the sponsors senior management team.
It is important from the outset to set the stage with the investigators. Why are we using ePRO? What benefits does it bring to the sponsor? It may require more work on behalf of the investigator which will need to be compensated for. It is also about setting expectations. Things will go wrong, issues will need to be resolved, backup processes may need to be utilized, but the investigator must be aware that they have the support when needed and how they can access that support.
When implementing ePRO thought should go into understanding how to improve the investigators experience. For example, investigators can be working on multiple studies at the same time for different sponsors all using ePRO, so adding labels onto the packaging of shipped devices so that investigators can quickly store them together is a quick win.
As a sponsor it may also be necessary to implement an additional layer of support for the study team. When issues arise the investigator will contact the vendor helpdesk. Often the helpdesk are unable to provide an immediate remedy so the investigator will then contact the sponsor’s study team representatives. The additional layer of support sits between the study team and the vendor, collating issues, communicating technical information back and forth in a manner that is easily digestible and holding the ePRO vendor to account. This relieves the frustration experienced within the sponsor’s study team and reduces the likelihood of escalation.
It is important to remember that in accordance with ICH GCP guidance section 5.2.1  the sponsor may transfer trial-related duties to a vendor, however the ultimate responsibility for the quality and data integrity of the trial data always resides with the sponsor. In order to ensure data is collected, stored and transferred in accordance with ICH-GCP guidance the sponsor will need a suitable oversight strategy of the vendor’s processes. This may, at a minimum, include a qualification activity which involves auditing the ePRO vendor on a regular basis. It may also invoke some internal validation work to ensure, as the sponsor, your own organisation’s technical and study specific requirements for clinical systems are met.
It is not recommended for the sponsor to leave the responsibility of vendor oversight to the individual study teams. The study teams may not have the experience or technical know-how necessary to understand the challenges and considerations discussed earlier in this blog.
We would recommend a two stage process.
Stage one is the qualification of the vendors system by a centralized team including stakeholders from the data management and computer system quality departments. Once qualified, the vendor’s system can be classed as a platform that can subsequently be used on multiple studies.
Stage two is to have experienced stakeholders conduct study specific User Acceptance Testing (UAT) in order to test the many scenarios and nuances associated with ePRO and to ensure the system meets the requirements of the study Protocol. Once implemented and running live on a study it is far more difficult to update the system than finding and fixing the issue during the implementation phase.
However, UAT is the very least the Sponsor must do as part of the overall study specific validation activity (Stage two). The Sponsor’s quality management system (QMS) may also mandate that the implementation of any clinical system (which would include ePRO) requires internal validation documentation to supplement the vendor’s validation package. This can include documents such as a sponsor Validation Plan, Requirements Specification, Risk Assessment, Traceability Matrix and Validation Report.
ePRO vendors will often offer to provide a service to create UAT script on behalf of the Sponsor, however this is not recommended as a misunderstanding of requirements by the vendor may also manifest itself in the scripting. This can result in the script passing when executed when in fact it does not meet the requirements of the Sponsor.
For these reasons, having experienced validation professionals generating the deliverables and executing the testing is recommended.
The two parts of this blog have detailed, at a high level, many of the challenges that can be experienced during the implementation and use of ePRO. These challenges are summarized below:
These challenges, and others, often create frustration for the investigators and study teams, and in the worst case scenarios, studies can be put on hold or stopped completely, costing millions of dollars and preventing a product from going to market.
A mechanism to help mitigate, or at the very least support the investigators and study teams through, many of these challenges is for the sponsor to put in place a centralized ePRO team within their organization. This team, consisting of internal sponsor stakeholders or perhaps supplementing Scimcon resources into the team, would be responsible for the qualification of the ePRO vendor, the strategic implementation of libraries and standards and for supporting the implementation of ePRO study-specifically, providing help with creating validation deliverables and executing UAT, and being a second level of support during the conduct phase of a study. ePRO is fast becoming the standard and it is worthwhile investing early on in an internal team to ensure success.
To discuss how Scimcon can support your organization with the implementation of ePRO, please contact one of our consultants for an informal conversation.
 ICH harmonised guideline integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2) ICH Consensus Guideline, https://ichgcp.netThe challenges of implementing ePRO – part one?
When it comes to documenting the advantages of using ePRO over paper in clinical trials, the benefits are clear.
With all the advantages to using ePRO over paper it seems to be a no-brainer to use ePRO whenever possible. However, it’s important to be mindful of certain considerations and challenges that come with the implementation of ePRO within your organization before jumping in.
Historically the implementation of electronic clinical systems in general has been challenging. In the majority of cases it requires the move from a paper-based process to an electronic system in an environment where the reliance has always been on paper, hindering the adoption of computer systems that are seen as alien. Taking EDC as an example, the response to an international survey cited that 46% of respondents identified inertia or concern with changing current process, and 40% identified resistance from investigative sites as the major causes for adoption delays .
ePRO is not immune to these challenges. In fact, it could be argued that ePRO is even more susceptible. While ePRO suffers from the traditional technical issues and user acceptance that EDC experiences, ePRO is also placed in the hands of potentially thousands of study participants many of whom may have little technical understanding. Additionally, ePRO relies on hardware (mobile device or tablet), cell network or WIFI connectivity, translation into the participant’s local language, multiple userbase (study teams, investigators and participants) and local helpdesk support, all of which comes with their own set of challenges and associated costs and few, if any, of which are encountered with EDC.
ePRO is one of the few electronic systems that directly collects source data and as a result comes under increased scrutiny from a data integrity and quality perspective, especially when used for primary or secondary end point data collection. The system must always be available in order to allow subjects to be activated on ePRO devices. If a participant leaves a clinical site without an active device, this can result in missed data which can be construed as a serious quality issue and perhaps put subject safety at risk.
Before I go into the more detailed challenges associated with ePRO, let’s first consider the financial costs.
On the surface of it, it would appear that implementing ePRO is significantly more costly than paper. The expense of the devices, associated logistics and data usage (monthly SIM costs), the licenses, helpdesk and translations all contribute to costs that range from hundreds of thousands of dollars to multi-million-dollar contracts per study.
When making a business case for ePRO it is important to take into account the hidden costs associated with paper in order to compare the two.
When conducting a full assessment, the gap between the cost of implementing ePRO vs paper reduces significantly. ePRO vendors have attempted to provide examples which result in paper diaries actually contributing more cost to a study budget than ePRO.
The business case for implementing ePRO should not be solely based on raw cost. This will likely result in failure to get agreement at the leadership level. You will find it easier to get acceptance if you can prove that ePRO costs are comparable to paper while also concentrating on the non-tangible benefits as, in the case of ePRO, these are the real reasons for its consideration. Increasing the quality of your data collection results in more confidence in that data, which in turn reduces the likelihood of rejection when submitted to the regulators (predominantly for primary and secondary end point data). Receiving the data in real time and reducing the need for data cleaning can aid the ability to get a product to market quicker by shortening the timelines to close the study, which in turn results in cost avoidance.
Many ePRO vendors will provide a cost calculator; a spreadsheet where the sponsor can plug in parameters associated with their study to provide an estimate of costs before engagement with the vendor. Only a small number of parameters are required to calculate a good estimate with the most important being the length of the study in months and the number of participants. The length of the study drives the helpdesk, data usage and PM costs, whereas the number of participants drives the device, logistics and shipping costs. There are other costs associated with the configuration of the system, translation, shipping, number of sites etc, however these are often negligible in comparison for larger studies.
In summary; it is important to build a business case for ePRO within your organization in order to assist in gaining acceptance at a leadership level. The business case should include areas of efficiency over paper together with examples of ePRO costs using the cost calculators provided by the vendors, as well as emphasizing the other benefits of ePRO, such as subject safety, compared to paper solutions.
In the past, ePRO implementations were customized pretty much from the ground up, coding the study specifics into the vendor’s study builder toolkit. This resulted in a huge effort required to validate the system to ensure errors and bugs were captured before studies went live. Inevitably despite all this testing some issues did make it through to the live study, causing frustration for the participants, investigators and study teams.
Over the past decade the systems have become more sophisticated. Less code is required during the implementation phase, which has been replaced with configuration. Vendors have also introduced library functionality which allow sponsors to define questionnaires up front that can be reused across studies. As the questionnaire is not rebuilt every time there is less opportunity to introduce errors. Additionally, the ability to reuse questionnaires from a library also results in less work by the vendor per study, less validation on behalf of the sponsor and can reduce the time and costs during the implementation phase.
It may also be possible to standardize other areas of functionality, perhaps the workflow as to when questionnaires are made available to the participants, or the alerting system, or the visit schedule. It may not be possible to standardize across therapeutic areas, but within a therapeutic area where multiple studies collect the same data this approach can result in substantially reduced timelines during the implementation phase, while reducing the risk of software errors on the studies.
ePRO can be implemented in a number of different modalities. In this blog, we are concentrating on provisioned devices; devices that are provided by the ePRO vendor at a cost to the study Sponsor, and “bring your own device” (BYOD); where a subject’s own device is used as the ePRO instrument. It should be noted that all studies require provisioned devices to a certain degree in order to cater for cases where a subject either does not own a compatible mobile device or does not own a mobile device at all.
When provisioning devices, ePRO vendors are responsible for the associated logistics such as software installation and shipping. Vendors are generally very knowledgeable when it comes to the customs regulations in many countries, including the average timelines required to get a shipment to a site.
In scenarios where competitive recruitment between sites is employed, it is particularly important to plan ahead. As it may not be possible to predict the number of subjects that will be recruited at a specific site and therefore the number of devices required at that site, it is necessary to purchase a sensible overage of provisioned devices. Although costly it ensures sites will not run out of devices.
With an increasing number of the world’s population now owning smart phones, BYOD was seen as the natural progression for ePRO. It reduces the costs and burden of acquiring devices and the associated logistics and also reduces the monthly costs for data usage. These costs do not completely disappear as a certain level of provisioning is required for those cases where participants don’t own a compatible smart phone. BYOD also reduces risks associated with not having enough devices on site, especially, as mentioned above, with competitive recruitment. However, BYOD does come with own set of unique challenges, mainly associated with data integrity and privacy. Some considerations might be:
There are clearly a lot of benefits of using BYOD over provisioned devices with more and more sponsors feeling comfortable moving into this space, however it is important to consider the implications before doing so.
In the next instalment of this blog, we will discuss some other challenges of implementing ePRO in your organisation, such as connectivity, translations, and end user acceptance testing. Keep an eye on our Opinion page for part two of the series, coming soon.
 ‘Electronic for Industry – Electronic Source Data in Clinical Investigations’, FDA 2013 http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm328691.pdf
 ‘Welker JA. Implementation of electronic data capture systems: barriers and solutions.’ Contemp Clin Trials. 2007 May;28(3):329-36. doi: 10.1016/j.cct.2007.01.001. Epub 2007 Jan 11. PMID: 17287151.Planning for successful User Acceptance Testing in a lab or clinical setting?
User Acceptance Testing (UAT) is one of the latter stages of a software implementation project. UAT fits in the project timeline between the completion of configuration / customisation of the system and go live. Within a regulated lab or clinical setting UAT can be informal testing prior to validation, or more often forms the Performance Qualification (PQ).
Whether UAT is performed in a non-regulated or regulated environment it is important to note that UAT exists to ensure that business processes are correctly reflected within the software. In short, does the new software function correctly for your ways of working?
You would never go into any project without clear objectives, and software implementations are no exception. It is important to understand exactly how you need software workflows and processes to operate.
To clarify your needs, it is essential to have a set of requirements outlining the intended outcomes of the processes. How do you want each workflow to perform? How will you use this system? What functionality do you need and how do you need the results presented? These are all questions that must be considered before going ahead with a software implementation project.
Creating detailed requirements will highlight areas of the business processes that will need to be tested within the software by the team leading the User Acceptance Testing.
Requirements, like the applications they describe, have a lifecycle and they are normally defined early in the purchase phase of a project. These ‘pre-purchase’ requirements will be product independent and will evolve multiple times as the application is selected, and implementation decisions are made.
While it is good practice to constantly revise the requirements list as the project proceeds, it is often the case that they are not well maintained. This can be due to a variety of reasons, but regardless of the reason you should ensure the system requirements are up to date before designing your plan for UAT.
A common mistake for inexperienced testing teams is to test too many items or outcomes. It may seem like a good idea to test as much as possible, but this invariably means all requirements from critical to the inconsequential are tested to the same low level.
Requirements are often prioritised during product selection and implementation phases according to MoSCoW analysis. This divides requirements into Must-have, Should-have, Could-have and Wont-have and is a great tool for assessing requirements in these earlier phases.
During the UAT phase these classifications are less useful, for example there may be requirements for a complex calculation within a LIMS, ELN or ePRO system. These calculations may be classified as ‘Could-have’ or low priority because there are other options to perform the calculations outside of the system. However, if these calculations are added to the system during implementation, they are most likely, due to their complexity, a high priority for testing.
To avoid this the requirements, or more precisely their priorities, need to be re-assessed as part of the initial UAT phase.
A simple but effective way to set priority is to assess each requirement against the risk criteria and assign a testing score. The following criteria are often used together to assess risk:
Once the priority of the requirements has been classified the UAT team can then agree how to address the requirements in each category.
A low score could mean the requirement is not tested or included in a simple checklist.
A medium score could mean the requirement is included in a test script with several requirements.
A high score could mean the requirement is the subject of a dedicated test script.
A key question often asked of our team is how many test scripts will be needed and in what order should they be executed? These questions can be answered by creating a Critical Test Plan (CTP). The CTP approach requires that you first rise above the requirements and identify the key business workflows you are replicating in the system. For a LIMS system these would include:
Sample creation, Sample Receipt, Sample Prep, Testing, Result Review, Approval and Final Reporting.
Next the test titles required for each key workflow are added in a logical order to a CTP diagram, which assists in clarifying the relationship between each test. The CTP is also a great tool to communicate the planned testing and helps to visualise any workflows that may have been overlooked.
Now that the test titles have been decided upon, requirements can be assigned to a test title and we are ready to start authoring the scripts.
There are several different approaches to test script formats. These range from simple checklists, ‘objective based’ where an overview of the areas to test are given but not the specifics of how to test, to very prescriptive step by step instruction-based scripts.
When testing a system within the regulated space you generally have little choice but to use the step by step approach.
Test scripts containing step by step instruction should have a number of elements for each step:
A typical example is given below.
However, when using the step by step format for test scripts, there are still pragmatic steps that can be taken to ensure efficient testing.
Data Setup – Often it is necessary to create system objects to test within a script. In an ELN this could be an experiment, reagent or instrument, or in ePRO a subject or site. If you are not directly testing the creation of these system objects in the test script, their creation should be detailed in a separate data setup section outside of the ‘step by step’ instructions. Besides saving time during script writing, any mistakes made in the data setup will not be classified as script errors and can be quickly corrected without impacting test execution.
Low Risk Requirements – If you have decided to test low risk requirements then consider the most appropriate way to demonstrate that they are functioning correctly. A method we have used successfully is to add low risk requirements to a table outside of the step by step instructions. The table acts as a checklist with script executers marking each requirement that they see working correctly during executing the main body of step by step instructions. This avoids adding the low requirements into the main body of the test script but still ensures they are tested.
Test Script Length – A common mistake made during script writing is to make them too long. If a step fails while executing a script, one of the resulting actions could be to re-run the script. This is onerous enough when you are on page 14 of a 15 page script. However, this is significantly more time-consuming if you are on page 99 out of 100. While there is no hard and fast rule on number of steps or pages to have within a script, it is best to keep them to a reasonable length. An alternative way to deal with longer scripts is to separate them into sections which allows the option of restarting the current block of instructions within a script, instead of the whole script.
An important task when co-ordinating UAT is be fully transparent about which requirements are to be tested and in which scripts. We recommend adding this detail against each requirement in the User Requirements Specification (URS). This appended URS is often referred to as a Requirements Trace Matrix. For additional clarity we normally add a section to each test script that details all the requirements tested in the script as well as adding the individual requirement identifiers to the steps in the scripts that test them.
UAT is an essential phase in implementing new software, and for inexperienced users it can become time-consuming and difficult to progress. However, following the above steps from our team of experts will assist in authoring appropriate test scripts and leading to the overall success of a UAT project. In a future blog we will look at dry running scripts and formal test execution, so keep an eye on our Opinion page for further updates.Digital transformation: Revolutionising the labs of the future?
Scimcon has worked with many lab-based clients throughout our 20 years in the industry, across a vast range of projects. Here we discuss the current challenges that labs are facing in 2020, and the work that needs to be done through digital transformation to ensure that labs in the future can streamline and manage their data.
The limitations of the current laboratory information systems landscape
Today’s labs are facing similar challenges as camera companies. Camera manufacturers such as Nikon and Canon are now faced with the challenge of selling to a new generation of budding photographers, most of whom by now have grown up with increasingly higher-quality smartphone cameras. As a result of having access to technology that is designed for ease of use, this generation of users find themselves progressively more frustrated with traditional technology and methods required to operate today’s ‘real’ cameras. Where smartphones can offer instant uploads to online services; amazing results that leverage computational photography; and synchronicity between multiple devices, traditional cameras appear complicated, difficult to control and impractical. Camera companies therefore face the challenge of building usability, such as that found in smartphone cameras into their existing products, otherwise they risk losing a whole demographic of potential customers.
The analogy is that modern labs are facing a similar problem. As new generations of scientists join laboratory settings, many are finding the lack of synchronicity and usability of information management systems increasingly frustrating. Why can’t we check instruments remotely whenever we want? Why can’t data be easily transferred between devices or colleagues? Why isn’t all this information seamless? Limitations such as these can be hugely time-consuming, as well as resulting in reduced productivity and security risks for data with minimal protection. Similar to the camera makers, we are risking losing the best new talent to other areas of science. Digital transformation addresses these challenges head on, with the proficiency to make your lab more intuitive and efficient.
What is digital transformation and how can it enhance your current lab setup?
Digital transformation involves the integration of new technology and methods into existing lab technology. Although this advancement in technology is a relatively new development within the laboratory setting, lab managers are quick to realise that digital transformation is essential in optimising workflows and productivity. In 2018, 70% of labs were reported to have a digital lab strategy in place or were working towards one1– a number that we can only expect to have significantly increased since then.
Significant effort has taken place in laboratories over the past two decades or more, which has delivered substantial benefits. This effort has been focused on the key lab workflows and the matching informatics systems such as CDS, LIMS, ELN, LES and SDMS, to mention a few. The next decade needs to build on this success to create a true digital laboratory.
Digital labs of the future: what can we expect?
Digital lab transformation is more than just implementing informatics systems, it involves taking these systems and pushing them a step further. For example, a lab could connect instruments bi-directionally to LIMS or ELN, but digital lab transformation would also facilitate online monitoring of instrument status, automatic ordering of consumables, reserving instrument time, auto-tracking utilisation and the use of telemetry data to predict faults before they happen.
A digital lab may also utilise a feature rich LIMS, ELN or LES that enables collation and review of all results for an experiment, but a digitally transformed lab would also be able to collate results across potentially several LIMS and ELNs throughout an organisation. This would allow the promotion of internal and external collaborations, enabling the ‘science later’ paradigm of cross team, cross technique and cross experiment data mining. This, in turn, will progress artificial intelligence and machine learning.
Overall, a digital transformation is more than just providing scientists with the means to spend more time on actual science. It provides the complete toolset of a lab wherever a scientist may be, whether that is in the lab itself, in an off-site office, in a café or even at the kitchen table.
At present, even top laboratories face problems with a lack of modernisation, and this is a problem that is slowly trickling down to smaller labs that are starting to face similar challenges. If we continue to drive forward with the help of innovative technology, we could expect to see many labs becoming more efficient, more supportive of science and more reliable than ever before.
However, to do this, it is up to laboratory leaders to have a clear vision of where they see their lab going. It is hard to transform any business by only doing little bits, so it is up to the higher levels of lab personnel to decide what steps to take to ensure that their labs are working at optimal capacity and potential. This is where Scimcon can help.
How can Scimcon help to revolutionise your lab?
Scimcon is proud to offer a range of digital lab services to assist in digitising a lab, many of which are outlined in our introductory blog. We are also able to help labs go that step further, with our collective wealth of experience in the lab, both as scientists and project leaders. Whether it is the development of the strategy, the running of the programme, or providing resources and leadership for your projects, Scimcon can help you understand what you want to achieve, and how to reach it.
To find out more about types of projects we support, and how we can help you to transform your lab, get in touch.
1 ‘Despite steady growth in digital transformation initiatives, companies face budget and buy-in challenges’, https://www.zdnet.com/article/survey-despite-steady-growth-in-digital-transformation-initiatives-companies-face-budget-and-buy-in/
Outbreaks in recent years, such as SARS, avian flu, and Ebola, in retrospect seem to have been a testing ground for the current COVID-19 lockdown.
During those outbreaks, study sponsors experienced the challenges of managing clinical trials in traditional ways, and many therefore pushed forward their adoption of eClinical platforms to ensure they could still manage their trials in remote locations, while reducing the impact on their project timelines, ensuring their investigators and monitors remained safe, and enabling their subjects to demonstrate compliance.
The traditional process of conducting clinical trials involves face-to-face interaction with subjects, which is proving difficult in the current lockdown. Subjects still need to make visits to clinical study sites to meet with healthcare professionals however the need to take part in lengthy reviews of their paper diaries is removed when using ePRO. By adopting ePRO for subject reporting, it is possible to significantly reduce the need for close face-to-face interaction with subjects and speed up the collection of quality data. In addition study sponsors benefit from a huge reduction in the travel of the onsite monitoring teams as ePRO increases the ability to conduct remote study monitoring.
With ePRO, the reporting and audit trail is also improved, since it is possible to prove that patients respond daily in accordance with the study Protocol (not possible with manual records).
BYOD (Bring your own device) is another consideration. It is recognised by Scimcon that BYOD reduces hardware challenges associated with the shipment of devices, but more importantly in the current situation removing the need for devices to be passed from human to human both within the logistics departments of the vendors and between the investigators and subjects (often ePRO devices are reused between subjects on an individual study). An upcoming post will cover the BYOD topic in more detail,
The regulator’s requirements for Accurate, Legible, Contemporaneous, Original and Attributable (ALCOA) data are achievable with ePRO platforms, where it has always proved difficult to remove doubt with paper-based Patient Reported Outcomes. In paper records, it is far more difficult for instance to prove when information was recorded, whereas in eClinical platforms when and by whom data is entered is automatically recorded, giving more accurate insight. Legiblity issues obviously become an issue of the past with ePRO.
The clinical trials community has been debating the benefits of ePRO for many years, and with the advent of COVID-19 where face-to-face interactions need to be limited, its adoption seems prescient. ePRO is the no-brainer product for now and future trials, both on data quality and in order to reduce concerns of unnecessary social interactions. Scimcon has hands-on experience with global clinical trials projects and is proven with ePRO platforms, doing what we do best: serving the science community with our skilled project teams to manage data projects globally.
Read more about ePRO:
With 91 million results in google search for the term ‘digital laboratory transformation’, this area seems to be the buzzword of the 20s. Scimcon has long been a stalwart in this area, having provided global partnership in information management to big pharma, bio and clinical organizations for over two decades.
The combined experience of our team spans more than 200 years of hands-on project roles in life sciences! What Information Management projects need, Scimcon has delivered: we have seen every type of project from every type of angle and have a unique perspective on how to ensure success.
And digital laboratory transformation is our lifeblood.
So with the establishment of our new website, we are launching a blog to address the subject of the digital lab and eClinical systems, and try to tackle some of the challenges, whilst also dispelling some of the myths.
Analytical projects including Information System Strategies, LIMS, ELN & LES, SDMS, CDS, DMS, Stability Management and Instrument Integration to mention a few.
Scimcon’s original pedigree lies in the field of Information Management projects in the analytical laboratory. The company and its project consultants have extensive experience in:
With such an extensive knowledge of Information Management in laboratories and life sciences, Scimcon has more recently been invited to supply similar services for the clinical trials industry and especially in the move from paper to digital records. The development and adoption of new Drug Development Tools (DDTs) lies at the intersection between regulatory, science, academia and pharma drug innovation. It is generally thought that paper is a poor format for patient compliance in diaries, and data/ electronic adoption improves both compliance and record-keeping in clinical trials. With our relatable experience, Scimcon has been involved in applying its successful project leadership to the areas of:
Our blogs will help you to navigate the world of outsourcing project leadership for either your analytical or clinical Information Management project.
The first step is to recognize why partnering is helpful:
Successful projects happen when you can trust the partner who is helping you. You do not need to relinquish control of your Information Management projects, but to successfully take them forward a trusted supplier who is not afraid to challenge, and who is vendor-neutral, can bring so much to the table.
In both the largest and the smallest organization alike, the knowledge of the organization rests with its employees. This leads to a natural gap of knowledge between best practice, external and competitor knowledge, and learning from others.
Scimcon fills that gap, its combination of deep hands-on experience, combined with information systems skills, extensive scientific systems and organizational experience, and a commitment to project success, means that we are always committed to bringing successful projects over the line.
We know the shortcuts, we understand the limitations with vendor capabilities, we recognize the scope of your existing systems and we know how to get the best from your teams. And our 100% year-in, year-out experience as a project partner means that we are always working, always able to move projects forward, even when faced with organizational challenges.
Talk to us now, or contact us to discuss your projects, past and future alike.