There is an advantage in centralizing all safety data, clinical data, analysis and reporting with one provider. By combining resolve’s substantial biometrics, medical writing, and pharmacovigilance expertise, we offer a fully compliant and high-quality complete package of pharmacovigilance services. Our goal is to help our customers meet the strict regulatory requirements, along with managing the risk-benefit profile of products, in order to maximise product potential, whilst ensuring patient safety. From outsourcing of individual activities to the setup and management of an effective and efficient global pharmacovigilance system, Resolve provides solutions specific to the requirements of our customer’s organization and products.

If you would like to have control over your safety data but do not want the cost and delay of setting up a compliant safety processing system, Resolve has an alternative. We can set up and host your safety database and write your SOPs.

From Phase I to IV we cover drug and vaccine safety right through to the development cycle ensuring that ICH Good Clinical Practices are fulfilled. We have a passion to provide excellence and solutions for the services you require.

Pharmacovigilance Services

Resolve offer the following pharmacovigilance services:

  • PV Consultancy and Project Management
  • Serious Adverse Event Case Processing of Initial/Follow-up reports
  • MedDRA coding
  • Case Narratives
  • Medical Monitoring
  • Global Expedited Case Reporting
  • Medicinal Product Dictionary (XEVMPD) entry and maintenance
  • Safety Data Management & Global Safety Database – Oracle Argus
  • Legacy case transfer
  • Signal Detection & Evaluation
  • Development Safety Update Report (DSUR) preparation and submission
  • Global Literature Search & Review in support of the DSUR
  • Pharmacovigilance Quality Assurance including SOP development
  • Monthly compliance and status reporting
  • Pharmacovigilance Awareness Training
  • Reconciliation of Serious Adverse Events
  • Risk Management
  • Study documentation review and update, including protocol and Investigator’s Brochure