Clinical Trial Pharmacovigilance
Pharmacovigilance during clinical development is just one of the many services that PDS provide. You can be assured of a balance between robust compliance programmes for safety monitoring whilst keeping abreast of the changing nature of development programmes.
The Pharmacovigilance team here at PDS offers scalable services to meet the needs and demands of the small Phase 1 studies, right the way through to complex multi-centre and global studies. Our team has experience in studies involving a wide range of indications, product types and advanced therapies. PDS Services include:-
• Drug Safety Project Management
• EudraVigilance set up and management
• Responsible Person for EudraVigilance oversight
• 24 hour cover
• Development of Safety Management Plans (RMPs)
• Serious Adverse Events (SAEs) collection and follow up from clinical studies
• PV247 database for electronic management of SAEs
• Expedited Reporting to Competent Authorities
• Expedited reporting to Ethics Committees and investigator sites
• Reporting to Competent Authorities and Ethics Committees – quarterly and six monthly
• Reconciliation with Clinical Database
• Compliance review and oversight
• Signal Detection
• Independent Medical Review
Pharmacovigilance for both Clinical Studies and Post Marketing is what we do to help you. Managing risk and providing you with a service specifically built to help accomplish your goals.
Call us now on +44(0) 1476 512395 to discuss your project with one of our team.