Clinical Data Management
Flexible Clinical Data Management Enables a Successful CNS IND Submission
A start-up Pharmaceutical Company, with limited existing infrastructure and SOPs, was working on an investigational new drug (IND) for autism which required Clinical Data Management Support. The study involved providing inputs to protocol development, setting-up the database and providing full data management support including Biostatistics and Statistical Programming services.
This study was conducted primarily at 2 sites in the United States which required local client project team support that functioned as their extended team.
