Regulatory Insights
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Explore The 2024 Edition of Industry Pages™ — A Strategic Guide To Running Smarter, Faster, And Leaner Studies
6/10/2025
This 2024 Industry Pages report provides an in-depth examination of the Central and Eastern European (CEE) clinical trial strategy, highlighting its pivotal role in global drug development.
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The Benefits Of U.S. Biotechs Conducting Clinical Trials In Australia
6/5/2025
As U.S. biotech investment continues to rise, cross-border collaboration and trial design innovations are expected to further solidify Australia’s role in the early-stage biotech development pipeline.
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Ensuring Compliance When Using Wearables In Clinical Trials
6/4/2025
As wearable technology takes on a central role in clinical research, explore how its benefits can be maximized while navigating the increasing complexity of regulatory compliance.
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DCTs And Community-Based Research Execution And Compliance
5/28/2025
The FDA's regulatory endorsement of DCTs enhances their credibility, offering a pathway to more inclusive and accessible clinical research that benefits both patients and sponsors.
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RWD's Significance In The Largest FDA-Funded IOL Study Of Pediatric Patients
5/28/2025
With FDA grant support, the American Academy of Ophthalmology and Verana Health conducted the largest real-world study to date on intraocular lens (IOL) use in pediatric cataract patients.
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The Makings Of 'Regulatory-Grade' RWD In Ophthalmology Using AI
5/25/2025
Regulatory bodies like the FDA and EMA now prioritize real-world data in clinical research. Learn more about its value in enhancing drug development, regulatory decisions, and patient outcomes.
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How AI Is Shaping The Creation Of 'Regulatory-Grade' Real-World Data
5/20/2025
Regulatory agencies such as the U.S. FDA and the EMA are increasingly recognizing the value of real-world data (RWD) in shaping clinical research and informing regulatory decisions.
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Mastering The Complexities Of Gene Therapy Document Writing
5/20/2025
Gain the insight and strategic flexibility needed to confidently navigate the unique scientific, regulatory, and documentation challenges of gene therapy development.
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Balancing Science With Intellectual Property
5/16/2025
Joshua Kresh, Emily Michiko Morris, and Mark Schultz from IPPI: The Intellectual Property (IP) Policy Institute discuss the dos and don’ts of IP and trade secrecy protections for biotech.
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Why ePROs In Oncology Are Perfect For Capturing The Patient's Voice
5/15/2025
Recently released FDA guidance showcases why electronic patient-reported outcomes (ePROs) are ideal for capturing the “voice” of the patient. See how ePRO eases oncology trials.