Recognizing the fact that benefit-risk balance is periodically reviewed by the regulatory authorities and that many of the risksassociated with the use of a medicinal product will only be discovered and characterised post-authorisation, it is very vital to have an effective risk management plan of the medicinal product for its continued existence in the market.
VST Research has a broad range of experience in designing, implementing and managing Risk Evaluation and Mitigation Strategy (REMS). We create comprehensive REMS programs to comply with current FDA directives. Our programs are based on effective communication tools with targeted patient education and outreach initiatives combined with on-line clinical support services and electronic collection of comprehensive safety information.
The goal of the REMS program is to define the risk/benefit of a client’s product and to include such an analysis as part of its regulatory submission, labelling, and branding for post-marketing launch. VST Research takes a multi-faceted approach for a complete REMS program to help minimize risks for adverse events (AE’s), support patient compliance, monitor the occurrence of AE’s and side effects of investigational products and compile thorough safety profiles for submission to the FDA.
Our extensive experience in integrating REMS programs into product commercialization plans enables us to deliver solutions to our clients quickly and efficiently.
Our Risk Management services include:
- Commercial integration
- Communication tools and plan development
- Medical communication
- Observational study strategies and execution
- Additional pharmacovigilance activities
- Regulatory documentation development
- REMS analysis/evaluation