Pharmacovigilance
Prologue Research International's global Pharmacovigilance team provides experienced drug safety staff with expertise in oncology, the global regulatory environment, and pre- and post-marketing drug safety surveillance. Prologue tailors each project-specific SAE Management Plan to address our client's unique business and regulatory needs. The following services include thorough examination and quality control of all safety reports, yielding complete and accurate information throughout the product lifecycle.
Clinical Trials Services:
- Safety management planning
- Safety database services - set-up/maintenance
- Clinical protocol safety section development
- Investigator/site training
- Medical safety monitoring
- Review of serious adverse events (SAEs)
- Safety data transfers and/or legacy database integration
- Remote data entry into client's global safety database
- Reconciliation services - safety/clinical databases
- Safety narratives
- Regulatory dictionary coding - MedDRA, sponsor-specific
- Regulatory reporting (MedWatch, CIOMS)
- Distribution of expedited safety reports to investigators/IRBs
- Interim safety listings and reports, i.e., project status monitoring, Data Safety Monitoring Boards (DSMBs)
- Annual reports to regulatory authorities
Post Marketing Surveillance:
- Spontaneous adverse event reporting
- Signal detection
- Patient registries
- Periodic Safety Update Reports (PSURs)
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