Pharmacovigilance

Our strategy

ArrayDiagnostica’s pharmacovigilance units job is to identify the potential sources of risk and take a proactive approach to you and your patients’ safety needs, from study design issues such as inclusion/exclusion criteria optimization, through post-trial monitoring and follow-up. We have establised a Indian sourcing unit in Bangalore with a unique mix of Nordic dialogue based working tradition integrated into a Indian highly educated and effective workforce. Most foreign sourcing experiences struggles with misunderstandings in communication and working habits. Our PV unit is designed with a Nordic management and a stringent focus on our clients SOP’s and IT systems.
You will get the best of two continents. The result: an integrated safety and pharmacovigilance approach that maximizes program success, minimizes cost and delays, and optimizes your entire development program.

Our Safety & Pharmacovigilance services include:
  • Safety database set-up and management

  • Safety case processing and reporting

  • Medical monitoring

  • DSMB charter development, selection, contracting and management

  • Medical coding

  • Safety data review and management

  • Subject narrative writing