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.
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.
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.
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.
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.
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.
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.
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.
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.
ePRO works better in lockdown: How ePRO serves to keep clinical trials on track, from a distance?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:
https://www.ncbi.nlm.nih.gov/pubmed/25300613 and http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm328691.pdf
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.
