EQMS Implementation & Use in the Clinical Trials Industry: Part 1- EQMS and e-Learning Tools
Clinical Trials - 9 September 2015
We recently had the opportunity to interview Nathalie Bourgouin, PMP, and Senior Consultant and Project Manager at Skillpad, to gather her thoughts on the potential use of Enterprise Quality Management Systems (EQMS) for compliance in the Clinical Trials industry. In addition to having over 24 years’ worth of Compliance and Quality/R&D/GxP experience, she has also overseen compliance in clinical trials, and has structured e-learning and industrial training curriculums for the Life Sciences.
For this multi-part blog series, we asked her opinion about the current and future status of EQMS and e-learning tools in the Clinical Trials industry.
Daniel: In general, Nathalie, can you speak about the Clinical Studies and how EQMS and e-learning tools might fit in?
Nathalie: Sure, well first, in the clinical trials industry we must protect the patients and uphold ethical standards. Additionally we have to adequately obtain consent, and we have to ensure data integrity and protect it; we have to track and analyze and safeguard this data, and ensure it’s not being endangered or misrepresented. Although a lot of companies use tracking tools, there are still many incidents in a clinical trial tracked through informal channels such as emails, and recorded in spreadsheets. An EQMS would assist us in reducing risks in clinical trials by dependably tracking and addressing quality incidents, storing quality data, tracking subject files, and minimizing the risk of having to disqualify subjects. It would also assist us in building an appropriate, standardized clinical trial training curriculum, tracking what training is required by the various players, ensuring that training content is available, and confirming that training is completed in a timely manner.
Secondly, at any given moment, there’s a network of pharmaceutical multi-nationals (Sponsors), contract research organizations (CROs), and sub-contractors working on a vast number of trials, normally all in parallel, and they’re required to operate like well-oiled machines. Research used to be divided more into national jurisdictions, but now we increasingly find that scientists follow the lead of international organizations and governments. This is done in the pursuit of more unified methods that make working in tandem with scientists across the globe more feasible. Providing a cloud based EQMS to research scientists in clinical trials allows them to train, as well as track, record and capture information in the same system, further allowing them to more reliably reproduce repeatable, standardized data. In my opinion–and I’ve overseen compliance in a number of trials–there’s really no overstating the need for this.
Time is another important factor to consider in regards to compliance. In the time it takes a clinical trial to be completed, and they are immensely expensive and can stretch over years, you have people entering and leaving the company, you may lose your records, or getting them back may be a long, complex IT process. No one wants to spend 3 weeks with IT, forcing them to do forensic excavation in someone’s Outlook Inbox who no longer works for the company and who may not have for years. The difference between the regulation and the real world is of course the gap we’re trying to narrow with an integrated tool like SOLABS QM/Skillpad. It provides a level of continuity and a compliant, central repository… And it can do so over time.