CTMS & EDC: A system to do both - and more

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:

• EDC - Electronic Data Capture
• CTMS - Clinical Trials Management Systems
• CLIP - Clinical Investigator Portals
• Project - Clinical Trials Project Management
• Analysis - OK, it's SAS, but how do you get the data there?  What about real-time analytics?
• IRB & DSMB - Outside organizations with their own management systems, like a Click Commerce Research Compliance Automation solution?

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:

1. Start with Microsoft Office SharePoint Server 2007 and SQL Server 2008 as the foundation to build upon.
2. As discussed in the last post, we'll use Microsoft Office Project Server as a way to organize the information and provide us with a trial specific taxonomy, along with roll-up of reporting metrics.
3. To cover the EDC aspects, we'll utilize Microsoft Office Forms Server 2007 - which is a web facing InfoPath solution - to handle data entry and front-ending the workflow for data checks, etc.

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:

• SAS - With integration with .NET, SOAP, and Web Services.
• Medidata - We've demonstrated use of their Web Services API module that utilizes CDISC.
• Perceptive Informatics - At the DIA annual meeting a couple years ago, we did a demonstration using DataLabs (now Perceptive) and InfoPath integration, using Web Services and about 5 lines of code!
• EHR/EMR Integration - While it is still on the horizon, I think it is getting closer.  Check it out.

Resources to get you started:

• Configuring SharePoint for 21 CFR Part 11 Compliance
• Project Server and Office SharePoint Server 2007 Integration
• Project Server Architecture and Programmability
• InfoPath Forms Server Form Template Authoring
• Microsoft Clinical Trial Initiation solution

Finally - there are other organizations and software vendors that are thinking along these lines.  Check out the following solutions:

• A solution in place in the US Department of Veteran Affairs
• TENALEA - Trans European Network for Clinical Trials Services
• Transenda - An Office & Project based CTMS system
• StreamLogic - A Project Based CTMS system

Next up in this series:

• Using MOSS templates for maintaining Part 11 compliance
• Extranets & Identity Management
• Architecture Diagrams & Screen shots
• Validation and compliance