Functional Expertise

Medical & Safety

Ensuring patient health is the most significant objective in a clinical study, and drug safety and risk management are key contributors to safeguarding patients. Catalyst’s medical and safety monitoring teams bring their extensive experience and clinical expertise to your study, ensuring the necessary medical and safety surveillances are in place.

Safety Services Include:

  • Review and management of suspected serious adverse reactions
  • Individual Case Safety Report (ICSR) processing for serious adverse events
  • Preparation and distribution of MedWatch and CIOMS
  • Coding of adverse events and medications (MedDRA and WHO Drug)
  • Preparation of safety narratives
  • Aggregate report creation including DSURs
  • Management of adjudication and data safety monitoring committees

Our team has worked with a variety of safety databases including ARISg, ARGUS and others. We are proud to be an early adopter of the newly released Veeva Vault Safety database, bringing a novel new cloud-based technology that allows for greater visibility for risk mitigation and compliance for all members of the project team including you, ensuring visibility and transparency for all.

Physician Support

At Catalyst, our Medical Monitors are board-certified oncologists with training and specialties across the cancer spectrum, including pediatric, hematological and solid tumors. They play a significant role providing rigorous medical oversight from study design through delivery to ensure patient safety, including:

  • Medical and safety monitoring on assigned projects
  • Input into the study protocol, informed consent forms and project risk assessment
  • Medical/scientific expertise and training to project teams
  • Patient inclusion/exclusion and safety queries from investigational sites
  • Medical data review (reviews laboratory values, adverse events, coding documentaries and data tables, listing and figures as needed)
  • Patient data review to identify trends and risks across the study

Our Streamlined and Sponsor-focused Approach to PVG

  • Transparency with Safety Data
  • EDC to Safety Database/E2B Imports
  • Elimination of Redundant Processes/Documents