Drug, Device and Pharma Safety Surveillance Overview
Clinquest’s Drug Safety/Medical Device Pharmacovigilance and Medical Information teams have provided our clients with pre- and post-marketing safety services for nearly a decade.
Clinquest’s team of well-trained professionals has diverse and complementary technical backgrounds in medicine, nursing and public health, with experience in a variety of therapeutic areas.
- Comprehensive Case Management
- Trained pharmacovigilance specialists
- Coverage of pharmaceuticals, biologics, medical devices and nutritional supplements
- Direct patient safety and risk management support and consulting services
- Periodic Safety Reports
- Integrated Safety Summaries
- Special Issue work-up
- Company Core Data Sheet maintenance
- Development and implementation of safety and surveillance programs for investigational and marketed products
- Risk Mitigation and Management Plans
- Risk Evaluation and Mitigation Programs (REMS)
- Regulatory support and/or participation in FDA/EMA meetings
- Safety and risk management programs for new products
- Chief Medical Officer (CMO) services for clients without medical personnel
- Scientific Advisory Boards (SAB) and Data Safety Monitoring Boards (DSMB)
- Investment presentations
- Pharmacovigilance and Medical Information hosting services
- Medical Information and complaint reporting Call Center
- Medical Information services for distribution of peer-to-peer communication
- Literature Review Services and Medical Reviews
Clinquest is committed to safety and dedicated to the continual education of our team members involved in collecting, processing and analyzing this data. To support our commitment, we have developed an extensive proprietary training program for all of our pharmacovigilance personnel.
Clinquest’s client profiles range from start-up to large pharmaceutical companies with multiple development programs and pre-market and marketed products. Our team has worked in a variety of capacities on behalf of client organizations either on-site or as an on-shore service provider.