Risk-proportionate approaches to monitoring and management of your clinical trials.

Our clinical safety consultants can advise on the best way to develop the safety management plan (SMP) of your clinical trial or study, taking into consideration:

  • The study phase and indication
  • Cross reporting of SUSARs to/from other clinical studies with the same IMP Aggregate reporting
  • New target populations
  • Other parties or vendors involved in the trial execution, e.g., CROs, party responsible for the unblinding process
  • If the study is a voluntary or an imposed PASS; normally warranted under exceptional circumstances (for rare diseases)
  • If the study is a ‘sub-protocol’ of a complex clinical trial and characterized by extensive prospective adaptations such as planned additions of new Investigational Medicinal Products (IMPs) or intervention models based on sequential assignment e.g., ascending dose studies.

These parameters determine:

  • Serious Adverse Event (SAEs) reporting processes
  • Reference Safety Information (RSI) to be used as well as the terms of updating it
  • Reconciliation procedures
  • The handling of pregnancy reports and pregnancy follow-up
  • Reporting of serious breaches and of urgent safety measures (USM)
  • Continuous risk-benefit assessment (DSUR, IB, dRMP or dCSI) which will be used as the basis for developing the list of safety concerns for the RMP.

We co-develop and review safety management plans, with all associated forms, including business contingency planning for SAE/Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting, clean communication lines and documentation requirements. We collaborate with your team to minimize compliance gaps and to build an effective safety data management system keeping in mind  that all safety-related training pertinent to a clinical trial derives from the contents of the SMP.