Comprehensive safety management for clinical trials, including Safety Management Plan (SMP) development, SAE processing, and independent Data Safety Monitoring Board (DSMB) oversight.

Optimize Clinical Safety

We deliver risk-proportionate safety management tailored to your study’s phase and complexity. Our services extend beyond SMP creation to include full SAE/SUSAR reporting, aggregate safety reporting, and Risk-Based Quality Management (RBQM). With our expert DSMB support, we ensure independent oversight and data integrity throughout your clinical development program.

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.