Interesting how weeks become months when you're writing and updating blogs. This CTMS project certainly hasn't gone away, but it did go on a bit of a hiatus while my "day job" intervened. Enough excuses. Mea Culpa. On to the fun!
As we discussed in the previous post, the key to a clinical trials management system is thinking of it in terms of a project - after all, the people who run the clinical trial think of it in terms of a project, and it is measured in project management terms, so why not treat it that way from an architectural point of view?
A second and equally important "requirement" is one that we are increasingly seeing as an industry trend: having EDC (Electronic Data Capture) functionality and CTMS (Clinical Trials Management System) functionality in the same system, or at the very least having EDC and CTMS closely integrate and interoperate.
The clinical trials world of today is fairly fractured. Think of all the different systems - often standalone systems - that are used by Life Science organizations:
What if you could have a system that gets close to doing all of that - or at least being able to manage all of it - through one interface? How much would that save in training costs, integration costs, and implementation costs?
Well - that's the vision. Here's how we pull it off:
EDC forms in Forms Server can even handle digital signatures (with compliance and security being the subject of a future post) inside the InfoPath forms. This has implications for those organizations that are involved with SAFE BioPharma (worth checking out).
The beauty of all of this is that it is all Web Service enabled, which means that you have easier integration mechanisms with existing analysis and EDC systems:
Resources to get you started:
Finally - there are other organizations and software vendors that are thinking along these lines. Check out the following solutions:
Next up in this series: