Preclarus™: Pilot Of In-House CRA And Cross-Functional Data Liaison (CDL)

While conducting a high profile Phase III irritable bowel syndrome (IBS) program, PPD faced high screen failure rates and low enrollment. To ensure data currency and appropriate enrollment strategy adjustments, PPD had to work within the fixed price budget to develop the correct monitoring and data management strategy to meet the complex needs of this client’s program.

Ensure timely entry of subject data into the electronic data capture (EDC) system and provide timely and accurate resolution to database queries to maintain high data currency, provide the study team and client real-time access to study metrics and provide in-house support to clinical research associates (CRAs) servicing a high volume of sites.