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Pharmacovigilance and Safety
Safety and Pharmacovigilance


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GENERAL CAPABILITIES




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With recent updates in global regulatory requirements, clinical trials requiring centralized, formal adjudication of study endpoints are becoming critical. With the frequent overlap in reporting of SAEs and Clinical Events/Endpoints, the Clinical Endpoint team works collaboratively with Clinical Safety. This allows for more efficient processing of cases, communications with sites and sponsors, and prevention of unreported events.

The Medpace Clinical Endpoint team is composed of dedicated Clinical Endpoint personnel and in-house medical experts who provide clinical oversight and support, team training, and practical experience in adjudication processing and regulatory requirements. Clinical Endpoint associates have healthcare related degrees (e.g. registered nurses, pharmacists, physicians) allowing for critical and clinical review of all data prior to submission to the Clinical Adjudication Committee (CAC).

Services offered include the following:

  • Development of CAC Charters, site training tools, and other adjudication materials
  • CAC management, including selection, contracting, training and facilitation of meetings as well as collaboration with Academic Research Organizations
  • Streamlined communications; one point of contact for endpoint events and SAEs for Sponsors, Investigative sites, and CAC members
  • Event package compilation in tandem with SAE processing, including translation coordination and clinical/medical quality control reviews
  • Preparation of standard and customized adjudication status reports
  • Experience in endpoint adjudication in a variety of therapeutic areas including cardiovascular, oncology, neurology, infectious disease, and rare indications
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