clinical - Scimcon

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.

Please can you explain what data quality means to you?

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.

Why is data quality such an important asset in pharma?

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.

Why is the prioritization of data quality so important for healthcare organizations?

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.

Data quality, where should organisations start?

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.

If you were to give just one tip for ensuring data quality in clinical trials, what would it be?

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.

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.

What is the role of technology on data quality?

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.

References

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

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.

With 20 years’ experience in the Biotech and Life Sciences industry, Micah Rimer’s success has been primarily due to his ability to read organisations, frame the problems and identify the best path to bring people together to achieve the desired goals. During Micah’s time working in Biotech and at big pharma he has successfully deployed consultancy groups within lab informatics and clinical projects.

Scimcon has supported Micah and his teams extensively on high profile projects in big pharma and Biotech. In this blog, Micah draws on his valuable experience to provide insight and tips on how to best to engage and work with consultancy groups.

Deciding on the right Informatics Consultant for your pharma or Biotech company is not a simple task, despite the various vendors available. Informatics in the Life Sciences industry covers a wide scope, so it is unlikely you will find an appropriate consultant through Google’s search algorithms. To find the best fit, you should consider what the key priorities are for your engagement, find a partner that you can trust and work well with and one that can bring a unique perspective to your collaboration.

Identifying the right Informatics Consultant for you

Starting out with the key skills and contributions that are needed, as in any selection process, is the first step in identifying the right Informatics Consultant.

While technology is constantly advancing, I would encourage you to think hard if the tech skills are really the most important aspect for a successful collaboration. From my experience, while an understanding of the underlying technology and what it is capable of is important (be that LIMS, ELN, eCOA, eDiaries, PV software etc), what is of more importance is someone who can both communicate and partner with the organisation. A successful computerised system consists not just of the software, but also the people that will use it and the processes they will follow. All of those components must be balanced for a successful implementation, so while the technology piece may feel like the most obvious area to address, do not underestimate the work with the people and processes.

For example, there was a point in my career where I was asked to implement a Pharmacovigilance (PV) signal detection system for an organisation I was employed by. This had been a critical gap in the organisation for a long period of time, and there were several options on how to proceed, but no easily defined right answer. We could look to either evaluate and buy something off the shelf, hire a company to build a custom-designed tool, or alternately we could try to finalise a prototype that a programmer in the department had been playing around with for a while. (His tool had nice features, but still some technical gaps and no clear path forward to make it robust enough to use in such a highly regulated environment). In looking for external help, some may have favoured looking to recruit Informatics Consultants with a background in Pharmacovigilance, or perhaps with the technology skills to leverage the drug safety system platform. But in choosing Scimcon, I went with the partner I trusted to help evaluate the options and lead a successful implementation in that particular organisation. A fantastic off-the-shelf tool would never have been a success if people did not want to use it because they preferred the home grown highly customized (but invalidated) prototype.

What can an informatics consultancy bring to the table?

With Scimcon on board, we were able to evaluate the pharma and drug safety landscape and determined that there could be a good path forward with the prototype that had already been developed. We were able to establish an effective team, drawing upon the Pharmacovigilance expertise in the department to address business process and usage questions. The programmer who built the prototype had the vision for how the software should work and what needed to be done from a technical perspective. Scimcon was able provide the knowledge and experience of how to move a prototype to a production system and validate a custom-defined tool that had been built by a programmer who does not have expertise in documentation. The output was widely recognised as a huge success.

It is important to keep in mind what gaps you are trying to close and what capabilities are needed to fill them: – Maybe you need the knowhow to get a project completed in a challenging environment; the technical skills to do the programming; the expertise with documentation; or you need to access people who have exceptional attention to detail to make sure a system is appropriately qualified and works as intended.

Whatever your challenge, you should ensure that the skillsets available from your informatics consultancy match the challenges you are facing.

How to evaluate informatics consultancy candidates

As with many relationships, the more time you work together, the more trust you build up. This just proves that the importance of having established relationships and ways of working cannot be understated. No one is perfect, but the devil you know may indeed be a better fit than someone new to you. Always think about building up relationships for the future; it is a small world.

Dealing with adversity

With this in mind, when looking for life science Informatics Consultants to partner with, one key consideration is to determine how they will be able to deal with adversity. What are they prepared to do if they see that a project is starting to go sideways? When speaking with them, ask them about projects that did not go according to plan or did not work out, and how did they manage that situation? What did they learn from that? Do they do anything differently from those lessons learned? Consultants, and Informatics Consultants especially, have all been thrown into projects where the requirements and expectations were not appropriately set in the beginning, which lead to problems later. Good consultants always learn from these situations and avoid repeating the mistakes that led them down that path.

The quality of their questions

Another key consideration for the interviewing and recruitment process is the quality of the questions the consultants ask and how well they listen.

Before you speak with them, think about what questions you would ask if you were in their shoes, and not having access to all the internal information you have: – Do they ask the right questions? Maybe they ask some questions you had not thought of? And how well are they able to play back what you have told them?

Often sales or account managers are very focused on telling you how easy it is for their teams to deliver, and how they will be able to deliver no matter what restrictions and conditions you add into the situation. Are there any conditions of the setup that would prevent the consultants from accepting the assignment? If there is nothing you can state that would cause them to be concerned, then maybe they are too good to be true! Look for their understanding that implementing systems is not usually a walk in the park. A truthful consultant is extraordinarily valuable.

Hands-on experience

Of course, it is always good to check the references as well. Does the life science informatics consultant have customers that have worked with them over a long period of time at different companies?

Bringing in consultants is typically not so easy, so numerous long-term engagements at different stops can itself also be a sign of delivering quality.

You should also look for feedback on the work the consultants delivered. There is a huge business out there for the larger agencies which spend time and resources selling at the executive level, but then use more junior resources to do the work. Having senior people presenting and being able to provide a concise message is important, but by and large you typically want to find people who are getting the work done. You must never lose sight of the goals to deliver projects on time and the overall drive for results.

Consider all of these aspects and listen to your instincts. Typically, these are not small or unimportant investments in the first place. Taking time to ensure you have the right fit is important. At the end of the day, you need to feel comfortable and confident that the people you choose can be counted on to deliver for you.

The most valuable skills to look out for

To me, one of the most valuable skills I look for with Informatics Consultants is the ability to bring a unique perspective. In a management training course I once took, the advisor summed it up this way: “Look, you are all smart people. If you come to a situation where you do not see a solution, it is probably because there is not just one solution. When you arrive at a situation like that you will have to find some way to balance and continually adjust, as there is likely no one right answer.” When I am bringing people in to support me on projects, I am looking for that ability to connect the dots and leverage previous experiences to help find the best solution.

One of the valuable parts of working as a consultant is that you get to see a variety of companies, all with different setups. While some people find that lifestyle stressful or challenging, there is an inherent value in being exposed to so many alternative organisational environments. If you can synthesize new information and learn rapidly, all these experiences add up to quite some knowledge. The more you can see things repeated with modified parameters, the easier you can find what works and what does not work, which is why we look to simulations to find some solutions. Informatics Consultants that have worked in different Biotech and big pharma settings with a wide exposure to different projects can help bring that knowledge to your organisation.

Finding consultants who have worked in various parts of life sciences or in other fields can also help to provide a more well-rounded view. At times, that enables seeing solutions in places you might not expect. They can also recognise patterns in the organisation you may be too close to see. The combination of being able to share these insights, as well having seen so many challenges and varying situations, can allow consultants to provide services to you that you simply are not able to manage internally.

Final thoughts

Finding the right Informatics Consultant for your life sciences organisation is not an easy task; you need to make sure that you are bringing in the right skillset to match your situation.

The priority is to find people you can trust and who you feel confident can work in your environment. While the technology of course plays a role, do not overstate the importance of it and dismiss the (not insignificant) people and the processes aspect to our work. The system in itself will not be considered successful if people are not comfortably using it. Look for companies that can adjust to your needs and find solutions to your challenges as the landscape continues to change. In the end, that is what counts, finding a way to get the job done.

Scimcon is proud to offer its consultancy services to Biotech and big pharma companies around the world. To find out how we can help you achieve success in your implementation project, contact us.

As a leader in a pharmaceutical or life sciences organisation, getting the most out of your team and resources is always a top priority. After making the decision to proceed with a critical investment in consulting services, there may even be more pressure to find the optimal use of these time-limited external resources. So, how can you make sure you are using these resources to their full potential? In this blog, our industry expert Micah Rimer will show you how.

During Micah’s 20 years’ working at big pharma & vaccines corporations, including Bayer, Chiron, Novartis and GSK, he has successfully deployed consultancy groups within lab informatics and clinical projects. Micah has worked with Scimcon to support his teams on high profile critical projects

Frame the problem – what does your implementation project need to achieve?

As with any business situation, it is important that there is a common goal that everyone is aligned around.

It is essential that you do not waste valuable time revisiting the same conversations. Ask yourself: “Is it obvious what problem we are trying to solve?” Often, issues can arise when people are arguing about implementing a solution, whilst losing sight of the challenge at hand.

Take the example of Remote Clinical Monitoring: You might decide that it would be beneficial to have your Clinical Research Associates (CRAs) track and monitor the progress of a clinical study without traveling to clinical sites. That sounds like it could be very promising, but what is the problem that needs to be solved?

Without clear goals on what you want to accomplish with Remote Clinical Monitoring, it will be difficult to declare an implementation a success. In addition, if you and your organisation do not know what you are trying to achieve with a particular technical solution, it will be impossible to give your informatics consultants a clear set of deliverables.

One of the first times I hired Scimcon to support me with an informatics project, I had recently joined a pharma company and found myself in the middle of conflicting department objectives, with what seemed to be no clear path out of the mess I had inherited. The organisation had purchased an expensive new software system that had already become a failed implementation. After spending a year continuously configuring and programming it, it was no closer to meeting the business needs than when the project had started. There were two loud criticisms to address on that point:

This also highlighted a far wider range of issues, such as some people who felt their skills were not being properly utilised while problems went unsolved, and that the bioinformatics department might not have the right goals to begin with.

To solve this challenge, we sat down with Scimcon to identify all the different problems associated with the inherited project, and to clarify what we needed to do to turn it into a success. In taking time to review the situation and without too much effort, we were able to come up with four key areas to address:

With the help of Scimcon, we were able to define these problems and then focus on finding answers to each of the questions. In the end it turned out to be one of our most successful engagements together, award winning even. By just asking senior management what their biggest challenge was, we found their overriding priority was to have an overview of all the R&D projects going on. And while the new software was not particularly well suited for solving the bioinformatics problem that it had been acquired for, it could easily be used to map out the R&D process for portfolio tracking. Then, we turned our attention to the bioinformatics problem, which was easily solved by a bit of custom code from one of the bioinformatics programmers who felt that previously his skills were not being properly utilised.

Once we knew where we were, and where we wanted to get to, all we had to do was get there one challenge at a time.

Manage internal expectations – how will the informatics consultants work with your clincial/analytical teams?

Once you have identified and agreed on the problem that you want to solve, the next step is making sure the organisation is ready to work with your consultants. As with all relationships, business or otherwise, a crucial step is to make sure that everyone has the same expectations, and that all the relevant stakeholders are on the same page.

As there can be so many different roles and perspectives on the use of consultants, you need to make sure that you address all the different stakeholder perspectives. It is important to establish a positive situation, as you want the consultants to be able to work with your teams without unnecessary tension.

When I was just starting out with my first LIMS implementation (Laboratory Information Management System), I remember being impressed that you could hire someone who had the specific experience and expertise to guide you on something they had done before but that was new to you. I wondered, “why was that not done all the time? Why do so many implementation projects fail when you can bring people in who had solved that particular problem before?” When I asked Russell Hall, a consultant at Scimcon for us on that first project, he said that not everyone is comfortable admitting they need help. As my career has progressed, I have come to value that feedback more and more. There are many people who are highly competent and effective in their jobs, but are not comfortable with the appearance that they are not sufficient on their own. It is always important to manage for those situations, rather than assuming that everyone will welcome external help.

Lastly, it is also critical to manage expectations, regarding the use of consultants. Your boss may need to defend the budget, or be prepared to stand behind recommendations or conclusions that are delivered from people outside of the organisation. It should also be considered that management might not readily accept something that might seem obvious to employees working at a different level. By liaising with senior leaders from the outset, you can make sure both parties are aligned how the consultants will interact with people in the company, and what their role will be. This is important both to achieve what you want internally and also to make sure the consultants have a proper expectation of how their efforts will be utilised.

Communicate and adjust – how is your information managed between your team and consultants?

While it can be very tempting to feel that you can leave the majority of the project to the experts, the reality is things rarely go as smoothly as planned. As the life science business and information management have advanced over the last few decades, the amount of complexity and details has grown tremendously. It is more and more difficult for a single person to maintain an overview of all the relevant facts. The only way to be successful is to communicate and make sure that the right people have the right information at the right time. Your consultants are no different.

Many organisations have challenges in terms of taking decisions and communicating them effectively. For your consultants who do not typically have all the same access and networks in the organisation that internal staff do, it is imperative that you make sure they are kept up to date. You want to avoid them spending valuable time on focusing on areas and deliverables that have shifted to being less important. Finding ways to keep consultants informed on all the latest developments is absolutely necessary for them to be able to deliver successfully. Figure out what makes sense by considering the organisation culture and the consulting engagement setup. Whether it is by use of frequent check-ins or online collaboration, be prepared to put in additional efforts to make sure that the information gets to where it needs to go.

As well as good communication, organisations have to be able to adjust as needed. Occasionally everything does work out according to plan, but that is more the exception than the rule when it comes to complex life science informatics projects. While timelines and commitments are critical, it is important to view any project as a collaboration. There will be unexpected software issues. There will be unplanned organisational changes and problems. People get sick, life happens. By having open and continuous dialogue, you can be best prepared to make the adjustments needed to find solutions together to unexpected problems.

Ensuring success in your informatics projects

If you’re interested in working with Scimcon on your upcoming informatics project, contact us today for a no-commitment chat about how we can help you succeed.

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.

Reference:

^{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/

Demonstrating the need for ePRO: COVID-19 makes the point

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.

Why ePRO works so well in lockdown

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,

Moving from paper: better reporting and ALCOA principles

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.

Digital Laboratory Transformation

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:

LIMS (Laboratory Information Management Systems)
ELNs (Electronic Lab Notebooks) & LES (Lab Execution Systems)
SDMS (Scientific Data Management Systems)
CDS (Chromatography Systems)
Integration of laboratory instruments
Document Management Systems
Sample and Freezer Management Systems
Biobank Management Systems
Stability Management Systems
Information System Strategies
Project leadership
Business analysis
Technical specialists
User requirements gathering
Technical Audits
Gap analysis
Project requirement scoping
Management of tenders and RFP management
Information systems implementation management
Systems validation
Vendor audits and vendor selection
Regulatory compliance including ISO 17025
E-Signatures and compliance with Part 11
Designing and delivering systems training

Clinical projects including eCOA, ePRO, eDiaries, Drug Safety Systems & EDC

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:

ePRO (electronic patient reported outcomes)
eCOA (Electronic Clinical Outcome Assessments)
eConsent
BYOD (Bring your own devices)
Electronic patient diaries
Drug Safety Systems
EDC (Electronic Data Capture)

Top tips for partnering on projects

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.

Mark, please introduce yourself