FDA 21 CFR Part 11
A leading global clinical research organization (CRO) aimed to conduct Risk Evaluation and Mitigation Strategy (REMS) surveys—an essential process for ensuring the safe use of medications with serious risks. However, they faced challenges in finding a reliable partner with the expertise to navigate the specific REMS survey requirements while ensuring compliance with 21 CFR Part 11 and maintaining the highest levels of data protection. The CRO required a cost-effective, flexible, and scalable solution that met FDA regulations and allowed for expedited setup.
Read More: https://www.dacimasoftware...
A leading global clinical research organization (CRO) aimed to conduct Risk Evaluation and Mitigation Strategy (REMS) surveys—an essential process for ensuring the safe use of medications with serious risks. However, they faced challenges in finding a reliable partner with the expertise to navigate the specific REMS survey requirements while ensuring compliance with 21 CFR Part 11 and maintaining the highest levels of data protection. The CRO required a cost-effective, flexible, and scalable solution that met FDA regulations and allowed for expedited setup.
Read More: https://www.dacimasoftware...
07:32 AM - May 23, 2025 (UTC)
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