Our approach: risk-based but proportionate, focused on ’unearthing’ concerning safety patterns.

Sponsors need a reliable and centralized system to track signals, ensuring all safety actions are reconciled in a standard manner, independent of therapeutic category or geography. A signal generally involves an active substance regardless of its indication, strength or route of administration and applies to all brand names/medicinal products containing the active substance, including fixed combinations.

Our multidisciplinary team of scientists in collaboration with PV physicians have designed, implemented and overseen compliant signal management processes for over 650 INNs throughout the lifecycle of medicinal products – using the formal guidelines on SD in GVP Module IX, which also refers to CIOMS VIII – and have identified safety patterns emanated from AR data suggesting new safety information.

These processes:

  • Involve accurate source selection ranging from medical literature and social media to observational studies and clinical campaigns/trials/investigations; all scientific information concerning the use of medicinal products including quality, non-clinical, clinical, PV and pharmacoepidemiologic data are continuously screened;
    • Data sources include: clinical trial data, e-RMRs and line listings from EVDAS, FAERS, application dossiers, product information, PSURs, RMPs, EPITT, scientific literature, data provided by MAHs and sources such as registries and databases
  • Focus on the detection of any concerning safety patterns
  • Appositely update clinical campaigns through safety related protocols amendments, safety revision in the PIS/ICF and the IB (RSI) when applicable and confirm or reject potential risks or identified risks
  • Provide an adequate and tailored system set-up, which has been proven by excellent inspection outcomes, from EU and ex-EU (FDA, Health Canada) authorities
  • Ensure that requests from regulatory bodies – e.g., submission of an ad-hoc PSUR recommended by Pharmacovigilance Risk Assessment Committee’s (PRAC) or a recommendation to conduct a PASS – are tracked by the Safety & Medical Writing team in a timely manner.