Our brands & services
Safety
reporting
ClinSearch is your trusted partner in ensuring patient safety.
The ClinSearch team has expertise with training investigators and supporting staff, reviewing medical data on CRFs, and writing safety reports. Our MedDRA-certified safety specialists (MD, PharmD, PhD, MSc) focus on the handling and reconciliation of ADRs and SAEs, signal & incident management, risk management, and minimization plans.
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 EDClinTM.
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
Resources
Senior clinical operations director
Safety physician
Pharmd safety specialist
QARA manager
MedDRA coders
Activities
AEs & SAEs reporting
MedDRA coding
Safety reports