Safety Oversight & Pharmacovigilance

We develop and implement safety-monitoring plans for all phases of clinical trials and global plans.  Our team provides clinical, scientific, research, and statistical expertise to provide ongoing assessments of clinical trials.

We offer the following safety Oversight services:

• Data Safety Monitoring Board/Safety Monitoring Committee (Set-up, Administration, and Management)
• IND Safety Report Preparation
• Expedited Safety Reporting to FDA and Sponsor
• Writing of SAE Narratives
• Study and Product-level (Sponsor) PVG
• Review and Evaluation of Adverse Event Reporting and Data
• Periodic Data Review
• Statistical Analysis and Reporting (SAP, Study/Protocol Design, Programming)

 

GENERAL INQUIRY
Corporate Headquarters
800.431.9640
330.278.2343
info@clinicalrm.comFederal Services Operations
301.620.1987
info@clinicalrm.comInternational Operations
800.431.9640
info@clinicalrm.com

 

DRIVING DIRECTIONS