SSRM Services
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Post approval risk management plays an important role for regulatory agencies to increase the save use of approved medical products. FDA as well as EMEA understands the need to give the public access to beneficial medical product as long as residual risk is properly managed. One effective method for active risk management is the use of a Post Approval Safety Surveillance (PASS) also addressed as Large Simple Safety Study (LSSS). They allow the collection of additional safety information under standard practice condition. To extend the information base already available from clinical trials phase I to III, phase IV trials or registries usually involve a high number of patients and run over a longer period of time. Efficient data collection methods are a prerequisite in order to handle the trial cost effectively. |
