“Are You Comfortable With The State of Your Clinical Trial SOPs?”
Many biotech start-ups struggle with developing standard operating procedures (SOPs) as they move into the clinical phase of product development. This is especially true when executives aren't well-versed in clinical trial operations or when sponsors are just beginning to get their feet wet with smaller trials in the post-market setting where regulatory authority oversight isn't required beyond that of the institutional review board (IRB).
SOPs create operational efficiency by ensuring processes have been scrutinized and optimized. While the protocol and trial plans define study-specific processes related to the research objectives, SOPs define the general processes common to running all studies. We must promote these values while avoiding the falsification or misrepresentation of results.
Most importantly, we must ensure participant protection by taking special precautions with vulnerable populations, minimizing harm and maximizing benefits, and promoting respect for privacy, autonomy, and dignity.
The Summa Consulting Group can develop an entire library of clinical trial-related SOPs that are phase-appropriate in an expedited manner.
Contact us today to learn more. ([email protected])
