Let’s take, for instance, the electronic trial master file, or eTMF. (For background on eTMF versus traditional TMF, check out our previous blog post.) You can’t just drop a bunch of files into a Dropbox and call it a solution. There are i’s to dot and t’s to cross to make sure everything is being recorded and stored appropriately — things like checking that the data aligns with the DIA Reference Model, that the system is 21 CFR Part 11 compliant, that there’s a clear audit trail and full activity log. Plus, keeping in mind the functional reality that an eTMF has to play nice with the clinical trial management system (CTMS).
So, you can see how the time and money and hassles can start piling up.
What does sensible eTMF look like?
This is especially important, of course, for smaller organizations that are perpetually dealing with resource constraints and facing decisions about spending priorities. Is it really necessary to invest hundreds of thousands of dollars in an enterprise-class behemoth just to cover your regulatory bases?
The short answer? No. Which leads to the obvious question: What would an alternative solution look like?
For starters, a more practical approach would check all of the boxes we mentioned above, including the all-important CTMS integration. On top of that, you’d want a solution that’s easy to set up, easy to learn and use — no point in investing in something that’s going to create headaches and impede efficiency down the road.
Sounds simple. The trick is getting all of this without breaking the bank. Oh, and while we’re building our wish list: being able to get all of it up and running as close to yesterday as possible.
The best way to do eTMF is your way.
Spoiler alert: This sensible approach to eTMF actually exists. Yes, we know it’s not what you may have been hearing. There’s been a drumbeat in the industry that if an eTMF solution isn’t immense, doesn’t have every bell and whistle, and doesn’t take months to define (and even longer to implement) — translation: doesn’t cost and arm and a leg — it can’t be any good.
We can tell you from experience that’s simply not true. (We’ve been at this for a while now, and we have the CTMS to prove it.) Yes, some large organizations do require expensive, custom-made eTMF solutions. But most don’t. In the vast majority of cases, it’s preferable to have a solid, flexible eTMF that gets the job done just as well and can be installed in a small fraction of the time for an even smaller fraction of the cost.
It’s all about maximizing the value of your investment — not just for today but as your organization and clinical trial needs grow.
That’s where the flexibility is key. Someday, you may want to work with a different vendor. Someday, you may have the need for a more heavy-duty or customized solution. Someday, it may make sense to invest in full-scale document management system. Whenever and whichever someday comes, you’ll want a painless path for migrating eTMF data and records, not to mention a complete soup-to-nuts archive easily accessible for future reference.
eTMF: That was easy.
To sum up: Getting compliance-ready, robust eTMF doesn’t have to be agonizing or expensive. In fact, when you get eTMF as part of Bioclinica CTMS, you can take advantage of incremental add-on pricing and quick-start implementation.
Ready to find out more?