Our Services

Safety & Medical Monitoring

At Trident Clinical Research, we understand that safety is paramount during all phases of clinical research. That is why Trident has a qualified in-house Medical Monitor and an experienced dedicated Safety Officer who can attend to your medical monitoring and safety-related requirements.

Our in-house Medical Monitor is GCP-trained and experienced in all phases of clinical research and can provide the following medical monitoring services:

  • 24/7 medical support to sites for study protocol interpretation and subject medical management.
  • Medical review and assessment of serious adverse event (SAE) reports.
  • Preparation of SAE narratives for regulatory reporting or inclusion in clinical study reports.
  • Assistance with, and participation in, Data Safety Monitoring Boards.

Our dedicated Safety Officer is highly familiar with local safety reporting requirements and can provide the following safety-related services:

  • Receipt and processing of initial SAE reports.
  • Communication to sponsor within 1 business day for all SAEs.
  • Timely follow-up of SAEs to case closure.
  • Safety reporting in compliance with local regulatory requirements.
  • Preparation and distribution of investigator notification letters.