08.14.25 -- Why CRO Site Network Strategies Confuse Me

Selecting the right vendors sets the foundation for efficient operations and reliable outcomes, and these ten essential principles can guide sponsors in making informed vendor choices.

For early-stage biotech companies, the road from discovery to market is fraught with challenges, and in this environment, strategic partnerships with CROs have become a cornerstone of clinical success.

This piece explores intentional culture-building as a strategic asset in FSP engagements, transforming transactional relationships into enduring, high-performing partnerships.

Rare disease clinical studies demand a specialized full-service CRO with expertise in enrollment, site selection, and global regulatory knowledge for accelerated recruitment.

An expert answers your question about the regulatory advantages of conducting your clinical study in Canada versus Australia. Watch now to learn more.

As cell and gene therapies (CAGTs) evolve, adaptive strategies are crucial to accelerating development and ensuring timely patient access.

The FDA’s recent draft guidance on accelerated approval outlines tougher standards for confirmatory trials and introduces a faster process for withdrawing approvals.

Explore the rapidly evolving landscape of regulatory processes as they undergo a profound digital transformation, highlighting how emerging technologies are reshaping traditional regulatory frameworks.

Strategic guidance helped SpringWorks Therapeutics, a biopharmaceutical company dedicated to advancing precision medicine, to refine their regulatory strategy for late-stage development.

Learn how an innovative formulation platform reduced development timelines and allowed a sponsor to find the optimal nafamostat formulation without adding unnecessary delays.

Successful clinical trials start with an efficient protocol review. Get your clinical trial to the starting line while ensuring participant health and safety.