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Medical products companies are often forced to make complex decisions with minimar hard data. Decisions about product safety are most often made in this fashion because during drug development, it is infrequent that well controlled clinical trials are designed and powered to answer safety questions. Unfortunately, questions about whether safety information constitutes a "signal" must be answered each day within medical products companies.
The process by which a company takes these decisions is critical for several reasons:
- From a patient safety perspective, good decision making is necessary to ensure appropriate availability of medicines that convey least risks.
- From a product liability perspective, good governance processes are important to ensure that medical/scientific decisions regarding safety can be made in a robust, defensible manner
- From an organizational perspective, it is important that organizations are aware of who has decision making authority around certain critical issues
SSI Strategy has vast experience in designing and effecting robust and reproducible safety governance systems and is well positioned to perform a diagnostic review of the set of governance processes in place within a safety system. We can advice on the best fit design for a particular organization.
In the event that a company prefers to have external governance, SSI Strategy can develop and administer such a system from an independent, third-party perspective.
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