Newsletter | February 19, 2025

02.19.25 -- Mobile Research Trends And Recommendations

SPONSOR

Webinar: Introducing Rave Lite- A Smarter, More Cost-Effective Way to Run Clinical Trials and Medical Device Studies

Many in the industry consider EDC a commodity product. It has never been more important to have a robust, scalable, flexible, and easy-to-use solution. Discover how Rave Lite changes the game by offering a simpler, more affordable alternative that enables sponsors and CROs to launch studies faster, with fewer resources, and at a lower cost. Register here.

TRIAL MANAGEMENT

How One Biotech Is Using FDA 505(b)(2) To Get Drugs To Patients Quicker And Cheaper

Guest Column | A conversation with Terran Biosciences CEO Sam Clark, MD, Ph.D.

Terran Biosciences CEO Sam Clark, MD, Ph.D. explains how his team is leveraging the 505(b)(2) regulatory pathway to get its new schizophrenia drug to patients quickly and affordably. 

Improving The Patient Experience In Clinical Research

Article | By Mike Stratton, CSSi - An Elixia Company

To preserve the quality of care and build a more effective approach to trial design, a sponsor must consider their approach to patient recruitment and enrollment early and often.

Three Ways To Accelerate From Trial To Market

Article | Halloran Consulting

Moving from pre-IND to IND involves preparing for FDA interactions with a focused pre-IND meeting request and package, Selecting the right CRO, and ensuring data integrity.

Advancing Your API To First Human Dose Trials More Efficiently

Application Note | By Ed Groleau, PCI Pharma Services

Learn how end-to-end support for development and manufacturing, clinical trial services, advanced drug delivery, and commercial packaging can accelerate drug development and time to market.

Think U.S.A.: The Operations Behind Your Clinical Trials

Video | Altasciences

Ready to think differently about early-phase clinical development? Check out the spotlight on our U.S. clinical facilities and the incredible teams behind them.

SPONSOR

The Health Equity Congress (May 5-7, Atlanta) is the premier gathering where pharma, biotech, and med device leaders unite to drive organizational transformation in health equity. Industry pioneers share data-backed strategies to enhance patient recruitment, accessibility, and community engagement. Gain critical tools to scale representation efforts, build trust, and integrate equity into corporate strategies. This one-of-a-kind event turns competitors into collaborators, accelerating sustainable health equity.

DECENTRALIZED TRIALS

Not A Bad First Year

From The Editor | By Dan Schell, chief editor, Clinical Leader

Dan Schell, chief Editor or Clinical Leader, summarizes his first year in this role and highlights some of his key takeaways and lists some of the people who have helped him better understand the clinical trials ecosystem. 

DCTs For Older Adults: Mobile Research Trends And Recommendations

Article | By Miranda McLaren, PCM Trials

Learn how DCTs can be tailored to suit the needs of older adults, potentially transforming geriatric clinical research and addressing the unique challenges faced by this growing population.

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You're receiving the Wednesday edition of the Clinical Leader newsletter, focusing on Decentralized Trials and Trial Management. To make changes to your newsletter selections, update your topic preferences.

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  • Clinical Trial Technology (Tuesday)
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