The Medpace Clinical Safety, Clinical Endpoint Adjudication, and Postmarketing Pharmacovigilance Teams Understand Lifecycle Risk
At Medpace, we take nothing for granted. Managing risk is a critical component to a compound’s success, both during the development process and into commercialization. The ability to manage global adverse events and product complaints requires a quality driven process, innovative technology, and robust services designed to drive a comprehensive program.
Safety and pharmacovigilance risk management has gained increased importance in global drug development due to a number of recent high profile drug withdrawals and growing expectations from consumers regarding product safety. While Medpace is focused on the rapid approval of your compound and pharmacovigilance monitoring thereafter, we also recognize the importance of identifying and assessing risk during clinical trials.
To meet increasingly complex and diverse global regulatory requirements, Medpace has developed a comprehensive suite of pre- and post-authorization services designed to expedite approvals and ensure ongoing safety. This process is monitored by licensed healthcare professionals (e.g. registered nurses, physicians and pharmacists) who are trained to effectively assess, analyze and evaluate the emerging safety profile of your compound with an exceptional level of quality and compliance.
Medpace is a global full-service clinical research organization (CRO) providing Phase I-IV core development services for drug, biologic, and device programs as well as post-authorization pharmacovigilance services. The Medpace Clinical Safety, Clinical Endpoints, and Postmarketing Pharmacovigilance teams offer global capabilities with offices and personnel in the United States and the European Union (EU).
Medpace Safety and Pharmacovigilance Call Center
The Medpace Call Center provides phone center coverage during business hours Monday through Friday, excluding holidays. The call center team consists of healthcare professionals who manage all incoming and outgoing calls.
- Special request accommodations are available (e.g. medical inquires and litigation inquires)
- Voicemail options are available 24/7
Medpace Safety and Pharmacovigilance Medical Monitor Team
Medpace is unique in its physician-driven approach to clinical research which gives Sponsors the advantage of early and ongoing insight and guidance from therapeutic experts throughout trial design and execution.
The Safety Evaluation and Medical Review of adverse event cases is performed by a Medpace Medical Monitor (MM), who is an appropriately qualified and trained physician. The MM also routinely monitors and evaluates for newly identified safety signals and assists in aggregate report preparation.
Medpace Safety and Pharmacovigilance Aggregate Reports
The Aggregate Reporting process is a collaborative approach between various Medpace teams including Safety, Medical Monitoring and Regulatory Affairs to prepare, QC, publish and submit periodic and annual reports (e.g. DSURs, PSURs, and PADERs). Local and global reports are written and submitted as per regulatory regulations specific to each product and as requested by the sponsor.
Medpace Safety and Pharmacovigilance Technology
The Medpace Safety and Pharmacovigilance team uses ClinTrak®, a bespoke scalable technology platform that is fully validated and 21 CFR part 11 compliant, for electronic tracking, review and reconciliation of source information received from multiple media sources.
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