Choosing the optimal EDC platform for your clinical trial

The use of Electronic Data Capture (EDC) and Electronic Case Report Forms (eCRFs) has become the gold standard in clinical research.
As a result the market has become flooded with EDC vendors of varying levels of functionality and quality. 

To choose the correct platform for a study, the following aspects of the EDC vendor should be considered:

• Reliable and user-friendly EDC system – a critical factor
• An experienced team responsible for the process of EDC and eCRF set-up
• Set-up and validation of the eCRF contents and online edit checks
• Fast implementation with maximum control
• EDC support, 24/7 help desk
• 21 CFR part 11 compliance
• Additional modules that can be included:
         Pharmacovigilance (including generation of MedWatch 3500A and CIOMS forms)
         Laboratory data processing (multi-center study)
         Flexible management listings and reports
         Integration with other systems: IWRS / CTMS
         eSource – electronic source documents
         eICF – electronic informed consent form signature
         ePro – electronic patient report outcome (questionnaires/diaries)

The following should be considered as “must have” functionalities when choosing an EDC platform:

• Data security
• Multiple environments – demo vs. production
•  Good performance and stability

The budget is an important factor when choosing an EDC system. Try to choose a platform with minimal surprises to avoid unexpected payments for each additional task. It is important to note that even the best planned studies will require some adjustments.

We at TechnoSTAT have a track record of dozens of studies and thousands of patients which are managed and executed using the Target Health EDC system.