Clinical PV Services
Ensuring Safe and Consistent Processes Throughout Your Clinical Trials
The capture and analysis of safety data is critical in clinical trial management, as trials ultimately must demonstrate safety as well as efficacy. This process can quickly become challenging, especially when there are multiple trials being managed by multiple contract research organizations (CROs). Variations in the safety processes themselves, as well as in the safety data located in separate databases, can bring accuracy of safety data into question and could compromise regulatory approval.
ProPharma Group’s experts manage safety requirements for clinical trials across a broad range of therapeutic areas, all while utilizing the single global safety database, Argus. By working with a dedicated safety provider, you can ensure consistent safety processes across all studies, even when running multiple trials with multiple CROs. Working closely with sponsors and CROs, we develop Safety Management Plans (SMP) to meet the requirements of study protocols. Our expert staff of pharmacists, nurses, and physicians work with you from start to finish, ensuring that your study meets all regulatory requirements for safety as well as the highest medical and scientific standards.
- Development of Safety Management Plans
- Processing of SAEs and Other Events of Interest
- Regulatory Report Submission for SUSARs
- Cross reporting to IRBs and Ethics Committees
- Annual Reports: IND, DSUR, etc.
- Responsible Persons
- Reconciliation with clinical database
- Signal Detection
- Safety Database Hosting
- Investigator Meetings
- Data Safety Monitoring Board Management and Participation
- Health Hazard Evaluations
- Protocol Development
- Audit and Advisory