Depression and RDC.

Depression

In a study of major depression in children and adolescents, INC Research pediatrics’ division was challenged with qualifying 40 sites to meet strict customer and FDA criteria. The project team interviewed 350 pediatric sites using an extensive feasibility process to ensure compliance with FDA requirements for child psychiatry experience in specific diagnostic and endpoint assessments. Following therapeutic and protocol training of the monitoring team, 59 evaluation visits were conducted at 47 sites in a 4-week period. Within weeks from the development of the feasibility questionnaires, visit reports were completed, site qualifications were analyzed and a recommended list of 40 sites was presented to the study sponsor.

RDC

INC Research’ data group was chosen to manage the data for a European phase I pain study with 48 patients. We were tasked with building an Oracle Clinical RDC project-specific database to mirror the customer’s in-house databases so that data could be directly loaded into their system. The site and customer staff also needed to be trained in the use of RDC. Within 6 weeks from the receipt of annotated CRF from the customer, the RDC database was finalized and available for entry and discrepancy management. 113 Unique CRF pages were created and tested; 250 edit checks were programmed, tested and finalized; and all staff was trained before the first subject was randomized. Data extraction from our database to the customer’s database was successful. And the scope of work actually decreased in the customer’s favor because of the highly efficient study conduct by our team.