Outsourcing services is quite common in clinical development. We outsource everything… Lab analysis of subject samples (central clinical labs) Interpretation of subject medical images (central imaging readers) Data capture at clinical sites (EDC and ePRO) Randomization and management of investigational product (IVRS/IWRS) Trial master files (eTMF) …and the list goes on and on…. [Read More…]
The Top 3 Actions You Can Take To Protect Your Company’s ePRO Data
When site personnel complete subjects’ e-diaries, bad things happen. Don’t let them happen to your company! A recent FDA Warning Letter questions the validity and integrity of ePRO data captured at a clinical investigator site. What’s a sponsor to do to avoid the same fate? How to Protect Your ePRO Data 1. Select an ePRO… [Read More…]
