Clinical Guest Contributors
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3 Practical Solutions For Easing Site Burdens
10/22/2024
Clinical research expert and breast cancer survivor Rosalie Filling shares three straightforward ways sponsor companies can help support clinical research sites.
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With The Rise Of PAOs And Site Networks, What Will The CRO's Role Be?
10/21/2024
In part two of this series, Jeremy Weitz discusses the roles of PAOs and site networks, as well as how CROs are partnering with them, and predicts how CROs might reinvent themselves.
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The Role Of The CRO Is Changing. Why?
10/21/2024
The role of the CRO is in flux. As sponsors shift to full-service outsourced (FSO) models to functional service provider (FSP) models, CROs are finding themselves redefining their role in the outsourcing relationship. Jeremy Weitz explains in this two-part series. on the changing role of the CRO.
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FDA Issues Bioresearch Monitoring Technical Specifications Document To Help You Organize Your Submission
10/18/2024
The FDA has issued the latest version of Bioresearch Monitoring Technical Conformance Guide: Technical Specifications Document: version 3.1. This version will likely be in place for a significant length of time as a road map for constructing this part of the NDA or BLA that you submit.
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Why Site-CRO Relationships Are So Strained — And How To Fix Them
10/18/2024
Empactful Ventures Founder Denise Bronner explains the issues that strain site-sponsor relationships and how to resolve them.
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Overcoming Trial Barriers By Looking Through The Lens Of Product Adoption
10/17/2024
In the final article of this series, Liam and Kim Eves explore how various drug candidates come inherent with barriers to adoption that directly impact how participants and providers engage with clinical research.
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Understanding How Strategies For Product Adoption Can Inform Clinical Trial Delivery
10/16/2024
In part two of this series, Liam and Kim Eves discuss product archetypes and adoption drivers as they relate to commercial endeavors and looks closely at how they can be applied to clinical trial execution.
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What Can Clinical Researchers Learn From Commercial Product Launches?
10/15/2024
Part one of this three-part series exploring modern drug development and its impact on clinical trials and new drug launches connects product adoption concepts with much earlier clinical trial activities.
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AI's Potential Must Reconcile With R&D And Regulatory Bottlenecks
10/11/2024
Evaluate's Daniel Chancellor explains that by working together to expand AI resources and adapt regulatory frameworks, the FDA and others can ensure the benefits of AI are fully realized while maintaining high standards of safety and efficacy.
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The Regulatory Affairs Function Is Evolving. Are You Evolving With It?
10/10/2024
The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the function is growing more complex, and specific AI tools can help regulatory processes.