EQMS Implementation & Use in the Clinical Trials Industry: Part 6 – Wrap-up
Clinical Trials - 16 December 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 part of our multi-part collaborative blog series, we asked her about how the current state of clinical trials, how SOLABS QM might serve these users, and how she thinks they’d benefit from the move.
Gordon: In general, can you speak about current models for Clinical Studies and how an EQMS might fit into that picture?
Nathalie: There are currently about three models for clinical trial organization at the infrastructure level, broadly speaking:
The sponsor company (either on their own or with CROs) more or less does everything in-house
Most or all work is outsourced to one or more companies that do this professionally, and then the announcements, etc. are published and/or circulated later
A more hybrid model, where an expert and highly-specialized team with pre-existing knowledge is hired—regardless of location in many cases—and they may be left to delegate or outsource themselves, but are always working towards a common goal, and always exchanging information.
And you can see with this exchange of information between teams, each with their own interests—but each with the trial’s and patients’ interests as well—that they would need something centralized that does versioning and keeps this all tracked and in synch. They need something that provides security, keeps detailed logs, allows feedback on reviews and approvals, and tracks and records all this for the regulators, if and when required. When I was listing those Clinical Trial models, I was mentally counting off the potential points of weakness as I went through the configurations: there’s a lot of junctures and exchanges going on in those scenarios, and a lot of places for something to go wrong!
"..if you’re working in a compliant, secure software with an audit trail—well then, the somewhat scary things we just mentioned are not even a possibility, because you’ve made Quality and regulatory compliance part of the way you do business. "
Gordon: And with this in mind, how might you convince companies and managers to break down the barriers to show them the potential results of the SOLABS/Skillpad collaboration?
Nathalie: Well, it’s fairly standard that we talk to them about the return on investment (ROI), as well as the lack of headaches. And then there are of course the more grave implications, like loss of license or liability, litigation, exposure, a bad public reception to an adverse event. But there’s also the more positive mindset that this can become the way you regularly do business, it can become routine for you. And if you’re working in a compliant, secure software with an audit trail—well then, the somewhat scary things we just mentioned are not even a possibility, because you’ve made Quality and regulatory compliance part of the way you do business.
We’re also sure to tell them that both Skillpad and SOLABS are user-centered, and this means things like we can provide both general and customized software at once, that can serve multiple user needs and various types of users.
But perhaps most importantly, we tell them that the continued use of an integrated EQMS/Training system like ours becomes not just training or document control or processes, but used across time and consistently, it produces results, it closes the loop in terms of Quality. And it’s then a part of operational excellence.
It’s when you make Quality a more active process rather than a passive one, that changes the way people use the software; it becomes a way for them to refine the process, improve staff knowledge and confidence, and have consistent, compliant business practices. So this is far more than training: it’s knowledge transfer as well. And it solves problems, and it has measurable benefits, and it lasts!