The PSI Difference

The PSI Difference in DMC Establishment & Management

20+ years of experience in managing all types of data and safety monitoring committees
Specially dedicated independent DMC Support Group provides all organizational and logistical support to DMCs
A strong team of biostatisticians who are highly experienced in DMC statistical support
A proprietary database of potential DMC members consisting of 800+ experts from different therapeutic areas

For more information, download our white paper How to Use Data & Safety Monitoring Boards: From Planning to Execution

Our Services

Identification of DMC members
Development of DMC charter
Generation of statistical outputs and their distribution to the DMC members
Administrative oversight at all stages of the DMC set-up and functioning
Scheduling and organization of DMC meetings
Preparation, finalization, and archiving of DMC meeting minutes
Filing of all DMC-related documentation and correspondence in the Trial Master File
Managing payments to DMC members

JOIN US IN SALES

References

¹ Fleming TR, DeMets DL, Roe MT, et al. Data monitoring committees: promoting best practices to address emerging challenges. Clin Trials 2017; 14:115–23.doi:10.1177/1740774516688915

² Califf R, Zarin D, Kramer J. et al. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA, 2012; 307 (17): 1838-1847.

³ Use of data monitoring committees in clinical trials. Guidance for industry. February 2024.