The increase in reporting of adverse events (AEs), scrutiny by public health policy makers, product recalls due to concerns over safety and efficacy and litigations against life science companies are now common. These factors combined with the complexity and rigor of the requirements of global regulatory agencies have resulted in companies paying greater attention to product safety in their pre-market approval process as well as post-marketing risk evaluation and mitigation strategies.
Sciformix’s comprehensive offerings in Safety and Risk Management include medical contact centers, case processing, reporting of individual safety reports, aggregate safety reporting, signal detection and risk management, and consulting all in support of our clients’ pre-market development and post marketing activities. Risk assessment requires expert judgment combined with input from scientists, clinicians, executives and strategic advisors. Sciformix’s comprehensive drug safety solutions approach of using the right expertise, process and technology means that decisions are based on superior knowledge, with unwavering attention to maintaining our client’s and the public’s trust.
We provide Safety and Risk Management expertise to support your pre- and post-launch activities in:
- Aggregate Reporting
- Signal Detection and Risk Management
- Safety Consulting
- Safety Technology
- Sciformix On-site Staffing (SOS) Services
We can use your systems and processes or ours and we can either provide end-to-end support or deliver select services. For organizations interested in comprehensive end-to-end PV support learn more about our PV in-a-box solution.
Sciformix’s Integrated Drug Safety solution seamlessly interweaves and synchronizes case processing (ICSR), aggregate reporting (PSUR, PADER, PBRER, ASR) and risk management across all phases of the product lifecycle. Our scientific experts aggregate and evaluate safety information from all sources, including individual cases, published safety data and competitive products to facilitate evidence-based proactive drug safety decisions.
Download information on our Safety and Risk Management services. (PDF)