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Why You Need a Validated Imaging Data Management Solution

In this white paper, we explore how organizations can follow 21 CFR Part 11 in clinical trials involving imaging data for submitting novel drug-based therapies and creating approvable, usable AI.

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To ensure the safety and efficacy of new therapies, rigorous regulation has been put in place to ensure their development has been documented properly. Research entities such as pharmaceutical and biotech organizations, academic medical centers (AMCs) and contract research organizations (CROs) must adhere to these regulations before a new treatment is approved for general use. 

In this white paper, we explore how pharmaceutical and healthcare organizations can follow 21 CFR Part 11 in clinical trials involving imaging data for submitting novel drug-based therapies and creating approvable, usable artificial intelligence (AI) for use in clinical workflows.