Is the Clinical Research Project Manager Role Calling You?

If all the anecdotal evidence about how many clinical research professionals “fall into” their first role in the field without exactly meaning to and find themselves in “sink or swim” conditions can be taken at face value, perhaps some comfort can be gained from knowing that progression into later roles is more often achieved at a deliberate and rewarding pace. Given enough time and exposure to multiple other areas of specialization in the clinical trials environment, many professionals who wish to continue working in the research arena, but who also desire a change of pace with new responsibilities, turn to project management. 

Decentralized Clinical Trials Back in the Spotlight Thanks to New FDA Guidance

Just when it seemed as if decentralized clinical trials (DCTs) were in danger of becoming “yesterday’s news” in light of all the attention being paid lately to applications of artificial intelligence in the clinical research enterprise, the tables have turned, if perhaps only briefly, thanks to the release of finalized new U.S. Food and Drug Administration (FDA) regulatory guidance on DCTs. 
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Providing the Blueprint for Gen AI Adoption in Clinical Trials

The increased accessibility of generative artificial intelligence (Gen AI) models like OpenAI’s ChatGPT and DALL-E has captured the popular imagination. You’d be hard-pressed now to find any leadership team in any sector that isn’t at least considering ways to leverage Gen AI. 

What Can Institutions with Local IRBs Do to Prepare for the Proposed FDA Single IRB Mandate?

To comply with the 21st Century Cures Act,1 the U.S. Food and Drug Administration (FDA) has released two Notices of Proposed Rulemaking (NPRMs). NPRMs are the initial public notice of a proposed change to federal regulations. These two NPRMs are intended to harmonize the FDA institutional review board (IRB) and informed consent regulations with the Federal Policy for the Protection of Human Subjects (the “Common Rule”) to the extent possible.