Clinical Trial Stage PV support

The provision of pharmacovigilance support in the clinical development stage requires a balance between the need to establish robust compliance programmes for safety monitoring whilst adjusting for the changing nature of development programmes.

Our PV department offers scalable services to meet the demands of the smallest Phase I study, through to complex multi-centre and global clinical trials. The team has experience in trials involving a broad range of indications, and product types including advanced therapies. Services include:

  • Drug Safety Project Management
  • Collection and follow-up of Serious Adverse Events (SAEs) from clinical trials
  • Electronic management of SAEs on the ARISg™ database
  • Expedited reporting to Competent Authorities
  • Expedited reporting to Ethics Committees and investigator sites
  • Six monthly and quarterly reporting to Competent Authorities and Ethics Committees
  • Responsible Person for Eudravigilance oversight
  • Reconciliation with clinical database
  • Compliance review and oversight
  • Eudravigilance set up and management
  • Signal Detection
  • 24 hour cover.
 

Named-patient and Compassionate Use Programmes

We provide a dedicated pharmacovigilance service for named-patient and compassionate use monitoring. These specialist services include:

  • Filing and Archiving
  • Drug Safety Project Management
  • Collection and follow-up of Adverse Events (AEs) from named-patient and compassionate use programs
  • Weekly literature searches of Medline
  • Electronic management of AEs on the ARISg™ database
  • Electronic expedited reporting to Health Authorities
  • Eudravigilance set-up and management
  • EU Qualified Person for Pharmacovigilance (QPPV) and deputy QPPV oversight
  • Compliance oversight
  • 24-hour cover
  • Filing and archiving.