NIDA Clinical and Data Management Services

Client: National Institute on Drug Abuse (NIDA), NIH

Client/study focus and needs: We provided clinical trial support for 22 NIDA studies whose goal was to develop new pharmacologic and behavioral therapies to treat addiction to cocaine, stimulants, and other drugs. We initiated and monitored operations at study sites, developed and maintained a data management system, developed study materials and documented procedures, and provided quality assurance and regulatory support.

Our customized approach: Using our Smart Study™© clinical data management system, we developed standardized data collection forms and procedures that could be used across studies, thereby saving time and resources as we moved from study to study. These standardization efforts allowed for easy aggregation of data across studies to facilitate meta-analyses. Lessons learned from each study were incorporated into subsequent ones to improve quality and efficiency.

Services: Clinical study coordination, monitoring, data management, statistical programming, medical writing, quality assurance, regulatory support

Results: Data from each study were analyzed and added to the body of knowledge about the treatment of cocaine and methamphetamine addiction. Studies ranged in size from single-site with 12 participants to multi-site with over 250 participants. Data aggregated across several studies provided a snapshot of the safety profile of therapeutics and a natural history of the manifestation and progression of substance abuse in studied populations.