Electronic Data Capture (EDC)

EDC means different things when used in different parts of the clinical trial process/operations. The overall objective is to skip or combine paper based data capture with electronic means. EDC has become a "standard practice" in large pharma companies moving up from around 20% in 2005 to more than 45% in 2007 which translates to a $3.1 billion market for 2006-2011.

The (purported)  benefits of EDC according to HealthInsights EDC report (available online) :

1. Reduction in time from last patient visit to database release
2. Reduction in the number of required queries
3. Efficiency gains from the reuse of forms
4. Reduction in site-monitoring costs
5. Reduction in project management costs
6. Reduction in time surrounding patient enrollment tracking

Now, that huge a market definetly attracts lot of players, a ball-park figure for number of EDC vendors would be more than 100, with 20 or so having a decent market share.  The list of vendors is large and includes:

1.  PhaseForward
2. DataTrak
3. eTrials
4. Medidata Solutions 
5. Oracle
   
6. Akaza Research (OpenClinica)
7. InferMed (actually a decision support software vendor)

If you would like to build your own EDC system please refer to FDA guidance on this at this website. Independent of which company you work with (by the way Excel or Access would not count towards EDC) you will be faced with one EDC system or more. So we will make it point to elaborate on the different vendors and their key strengths in future posts.