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Pharmacovigilance and Safety
Safety and Pharmacovigilance

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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 rapid approval of your compound, 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 services designed to ensure safety and expedite approvals. This process is monitored by licensed physicians who are trained to provide appropriate oversight and to analyze and evaluate the emerging safety profile of your compound.

Services provided by Medpace Safety and Pharmacovigilance include:

  • Global adverse event management for pharmaceutical (chemical and biologicals) and device trials
  • Collection, evaluation, analysis, and reporting of safety information, including serious adverse events, unanticipated adverse device effects, and other significant safety events
  • Safety narrative writing including physician review
  • Global Safety Event Reporting System: Providing a safety database for the life of your compound
  • Coding (MedDRA, WHO Drug) of adverse event information
  • Assessment and evaluation of reportability and submission of reportable events to global regulatory authorities, EudraVigilance reporting and e-reporting in the EU
  • Experienced certified user of EudraVigilance
  • Provide expertise on safety-specific national regulatory requirements in the many countries worldwide
  • Preparation and submission of annual safety reports, biannual line listing, and periodic reports to global regulatory authorities
  • Custom safety surveillance including adverse event and laboratory trend analysis for detection of safety signals
  • Pharmacovigilance for marketed products
  • Maintenance of a certified pharamacovigilance system for pharmaceutical companies in the EU
  • QPPV services for all EU countries
  • Preparation of post-marketing surveillance reports, including periodic safety update reports (PSURs) and periodic adverse drug experience reports (PADERs)

Adjudication Services

  • In-house Medical Experts provide clinical oversight and support, team training, and practical experience in adjudication processing and regulatory requirements
  • Associates have healthcare related degrees (i.e. RNs, pharmacists, MDs) allowing for critical and clinical review of all data prior to submission to the CAC
  • Development of CAC Charters, site training tools, and other adjudication materials
  • CAC management, including selection, contracting, training and facilitation of meetings
  • Streamlined communications; one point of contact for 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
  • Global capabilities with offices and personnel in the US and Europe

ClinTrak® Event Adjudication Management (EAM) System

The system is fully validated, 21 CFR part 11 compliant, and integrated with the full suite of ClinTrak systems. CAC members have 24/7 web-based access for independent review of cases and receive real-time electronic notification when data packages are ready for review. Formal adjudications are entered into ClinTrak EAM for inclusion in the final adjudication database with audit trails of the entire process. The result is rapid turnaround of adjudications, in days versus weeks. Want to learn more about Clintrak? Visit ClinTrak®

Want to learn more? Contact the location nearest you.