At Veristat we work with the sites, monitors, sponsors, and investigators to ensure proper and timely reporting of all safety issues, thus helping ensure the safety of trial volunteers. We provide:

Clinical Trial Safety Planning

Development of the safety management plan inclusive of outlining the safety management responsibilities between Veristat and the sponsor.
Creation of the pregnancy/safety guidelines and forms to ensure proper reporting of pregnancy and SAEs.
Oversight of the build and maintenance of the safety database based on the requiredments of the study specific protocol (in conjunction with the Data Management team).

Safety Adverse Event (SAE) Management

Triage of all initial and follow-up source documentation to ensure criteria for a reportable case(s) are met and review for accuracy and completeness
Assignment of case numbers to all new SAEs
Obtaining the causality assessment from the medical monitor within 24 hours
Communication with site(s) to obtain all supporting documentation (ex. Discharge summaries, autopsy reports, laboratory and diagnostics reports, etc)
Drafting of safety narrative(s) according to ICH guidance encompassing medically relevant information and query the site for additional or discrepant information
Completion of MedWatch/CIOMS forms
Provision of Global Submission of SUSARs to regulatory agencies

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Clinical Trial Patient Safety Management

Patient Safety in Clinical Trials is Our Number One Priority

Clinical Trial Safety Management Services

Clinical Trial Safety Planning

Pharmacovigilance in Europe

Safety Adverse Event (SAE) Management

Clinical Trial Patient Safety Management

Patient Safety in Clinical Trials is Our Number One Priority

Clinical Trial Safety Management Services

Clinical Trial Safety Planning

Pharmacovigilance in Europe

Safety Adverse Event (SAE) Management

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