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Business Risk Management-GettyImages-2151106988 The "One-Trial" Trap: Why 2026's FDA Efficiency Push Actually Doubles Your Operational Risk

When it comes to the FDA's new "one-trial" shift, researcher Johnathon Anderson, Ph.D., warns: Do not confuse efficiency with leniency. Here, Anderson offers three factors to consider when adapting to new FDA trial expectations.

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At Endpoint Clinical, our solutions proactively problem-solve. We expect the unexpected, so you can focus on reaching key clinical trial milestones.

Your trusted RTSM solution, PULSE is designed to support all study designs with configurable, pre-validated components. PULSE empowers study teams to easily manage randomization and trial supply workflows with flexibility and precision.

As a full-service contract research organization, Southern Star Research has the knowledge, industry relationships and technical expertise to get your early-phase clinical trial up and running safely and efficiently.

“Going the extra mile is a big part of our DNA. Personal attention can go a long way in ensuring the success of your next research study.”

Raffaella Hart, MS, CIP
Sr. Vice President, IRB and IBC Services

Fast, reliable IRB review for multisite studies backed by expert oversight and responsive support. With streamlined submissions, frequent meetings, and dedicated client managers, BRANY IRB helps you save time and money while maintaining full regulatory compliance.

Our dermatology studies provide results that are more than skin deep. Because the skin is the largest and most easily accessible organ, our dermatology research also facilitates drug development in other areas, including immunology and endocrinology. In addition, we are engaged in studying ways to improve wound healing.

Ergomed places patients and their care partners’ needs at the core of our services. We strive to build empathetic relationships with patients and their care partners, not just during the trial but also before and after. Our team provides personalized support, aiming to alleviate the burden of study participation. Ergomed and our trusted partners are deeply committed to bringing lifesaving treatments to patients.

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