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Safety reporting

Resources

Senior Clinical Operations Director
Safety Physician
PharmD Safety Specialist
QARA Manager
MedDRA coders

Description

ClinSearch employs a MedDRA-certified safety physician and a PharmD safety specialist focusing on the handling and reconciliation of ADRs and SAEs, signal & incident management, and support with risk management and minimization plans. The ClinSearch team has expertise with training investigators and supporting staff, medical review of CRFs, and the writing of safety reports.

We are also able to recruit key opinion leaders for Clinical Event Committees (CEC) & Drug Safety Monitoring Boards (DSMB). ClinSearch staff can write the manuals, manage the meetings and ensure the adjudication of endpoints. It is possible to collect the adjudication results online from any part of the world through an extension of EDClin.

The department can develop customized SOPs and tools for safety reporting and management.

Our solutions

Risk management plan
Study staff training
Handling of Adverse Drug Reactions
Handling of Serious Adverse Events
Reporting to CA & EC
CEC & DSMB management
Medical review
MedDRA coding
Case & Periodic safety reports
Quality control

Standards & Guidelines

Eudravigilance
MEDDEV
MedDRA

Day-to-day activity

AEs & SAEs reporting
MedDRA coding
Safety reports