Safety Oversight & Pharmacovigilance

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)


 
AWARDS

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GENERAL INQUIRY

Corporate Headquarters 800.431.9640 330.278.2343 info@clinicalrm.com
Federal Services Operations 301.620.1987 info@clinicalrm.com
International Operations 800.431.9640 info@clinicalrm.com

 
DRIVING DIRECTIONS