MANAGING AND REPORTING SAFETY DATA … Reliable Vigilance
Monitoring patient safety is critical to the well-being of clinical trial subjects and to determining the risk profile of promising treatments. PROMETRIKA understands the crucial role of serious adverse event (SAE) data collection and management, safety reporting, safety signal detection, and other pharmacovigilance activities in the drug development process. PROMETRIKA has the clinical safety and regulatory expertise, and the appropriate tools, to support sponsors in this crucial activity.
PROMETRIKA understands that the success of your pharmacovigilance program relies on a well-designed Safety Management Plan, timely monitoring within a robust safety system, and consistent communication with safety experts. Our team provides the many required reports, such as the Annual Safety Report (ASR), Periodic Safety Update Report (PSUR), Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Periodic Adverse Drug Expert Report (PADER), and Integrated Summary of Safety (ISS). We generate the listings to support IDMCs and CECs and our safety experts are prepared to participate in these safety review meetings. All documentation is in accordance with FDA, ICH, CIOMS and GCP standards and guidelines.
Using ARISg™, an industry leader in pharmacovigilance and clinical safety systems, PROMETRIKA’s team of experts collect, analyze, and report events in the formats and time frames dictated by regulatory authorities. PROMETRIKA provides the entire range of safety services and can assist sponsors with the development of SOPs for safety management
PROMETRIKA adapts to the unique needs of your company and your clinical program to provide tailored safety reporting solutions, leveraging the collaborative expertise of our safety specialists, biostatisticians, medical writers, medical monitors, and regulatory affairs professionals with diligent adherence to regulatory standards.
- Safety Database hosting via ARISg™
- Real time EDC SAE notification trigger
- SAE case management (receipt, processing, follow-up and regulatory reporting)
- MedDRA coding
- Narrative writing per Good Pharmacovigilance Practice (GPP)
- Medical safety review
- Literature review
- SOP development
- Worldwide regulatory report preparation and submission
- Signal detection and Risk Evaluation & Mitigations Strategies (REMS)
- Aggregate reports (DSUR, PSUR)
- Listings for IDMC and CEC review
- Pharmacovigilance System Master File (PSMF) services
- Legacy case migration