Pharmacovigilance Clinical Study Support

Clinical Study Pharmacovigilance Support

Our team of clinical study pharmacovigilance specialists will partner with you throughout every phase of your drug’s development. We understand the critical importance of having a robust protocol in place before study start-up.

Our experts will collaborate with you, offering guidance on the best approach to safety sections during protocol writing, ensuring everything is aligned for optimal safety oversight.
Additionally, the PDS team provides thorough support in reviewing Reference Safety Information, clinical study reports, and final study reports. We are committed to delivering timely, solutions-driven support, knowing that clinical study pharmacovigilance is vital to the success of your product.

At PDS, our clients benefit from personalised service provided by a highly qualified, proactive, and forward-thinking pharmacovigilance team. We work closely with you across all aspects of clinical study pharmacovigilance, ensuring seamless collaboration and expert guidance every step of the way.

Choose from our Services:

• Medical monitoring and advice
• Pharmacovigilance Risk Management Plan
• Global Literature Search
• Reconciliation of SAE’s
• Development of Safety Update Report (DSUR) and submission  
• Investigator Meeting PV Training
• Drug Safety Project Management
• Electronic expedited Reporting or Eudravigilance
• Reporting to the Ethics committees, investigator sites and Competent Authorities in the case of adverse events