Pharmacovigilance / Drug Safety
Pharmacovigilance and Drug Safety services for patient safety
Our expert Pharmacovigilance and Drug Safety Services teams located across Europe are focused on safety in clinical trial and post-marketing activities. Their exceptional, and vast experience spans multiple therapeutic areas and combines a global approach with local knowledge to ensure safety and compliance.
From early phase clinical development through to post-marketing, and whether as a full-service solution or stand-alone pharmacovigilance clinical trials and post-marketing activities, our experience and understanding free you up to do what you do best. Whether as part of a full-service solution or a stand-alone pharmacovigilance project, we rigorously extract and analyse safety data to detect signals, validate assessments, and compile comprehensive reports that support regulatory compliance and informed risk-benefit evaluations.
Navigating regulatory requirements is key to patient safety
We are committed to patient safety through meticulous data collection and innovative technologies.
Risk management is part of the overall safety assessment. Safety signal management is part of our risk management strategy. Signal management is key to identifying and managing safety issues. We provide safety solutions for pharmaceutical and consumer goods industries. We conduct safety surveillance during clinical trials and post marketing. Due to our expertise in safety writing we have the capability to deliver a wide range of safety reports and risk management plans. We provide an experienced team with a focus on clinical research and pharmacovigilance in drug trials and post-market with additional expertise in medical devices, combinations, immunotherapy, and gene therapy.
- A Team of 70 Safety Experts in Pharmacovigilance Cosmetovigilance
- Pharmacovigilance
- Medical Device Vigilance
- Cosmetovigilance
- Safety Data Exchange Agreement and Safety Monitoring Plan
- SAE Forms
- Pregnancy Forms
- Narrative Templates
- Submission Packages
- Timelines for Expedited and Non-Expedited Cases
- Safety Reporting
- Training Material for the Sites and The Project
- Team Adverse Event management (full case management from reception to submission)
- Management of back-log cases
- Aggregate Safety Reports (DSUR, PSUR/PBRER, RCO) writing
- Expedited and periodic reporting to competent authorities (electronic or paper)
- Line listing and summary tabulation management
- Global and local literature search
- Monthly activity and compliance reports
- Safety signal detection
- Regulatory Intelligence
- EudraVigilance Registration
- xEVMPD Entry and Update
- Safety Database Management
Expert team in Pharmacovigilance
With an average of 24 years of experience for each team member, we have successfully provided services to over 160 studies across the US and Europe. We have strong local and global coverage with involvement in product approvals, including processes from early phase to NDA, and expertly managing EU CT safety submissions with a focus on regulatory compliance.
Why working with us?
Helping you succeed in your project
How can we support your next project?
Whether you’re looking for a protocol review or a proposal,
simply reach out to us by filling our request for proposal.
