09.04.25 -- FDA's Elsa May Prompt Pharma To Rethink Regulatory Filings

Sponsors planning Phase 3 and pivotal clinical trials are facing fresh uncertainty as the FDA’s Diversity Action Plan guidance continues to shift.

Discover how Sarah Wilson, Director at Alkermes, revolutionized document collaboration using a document review platform to boost efficiency and overcome regulatory challenges in medical writing.

There were three new approvals across the therapeutic landscape in the second quarter of 2025, but despite those positive signs, overall dealmaking was flat for the quarter.

Delve into the importance of training and educating research staff on the sIRB process, fostering a culture of collaboration, and developing mechanisms for monitoring compliance and managing conflicts.

Learn about this integrated suite of services that spans global CRO capabilities, central laboratory services, and IVD & CDx regulatory development consulting.

Leaning on an interim Head of Quality offers advantages during the search for a full-time hire, such as flexibility and access to seasoned expertise for startups.

Site-facing technology is presented as a crucial enabler of efficient trial execution, aligning site operations with sponsor timelines and objectives.

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.

Targeted modalities are designed to bind specifically to receptors or biological targets, ensuring a more directed and effective treatment while reducing systemic exposure and unintended side-effects.

Selecting the right vendors can determine whether a clinical trial advances smoothly or stalls under budget overruns and delays.

Learn how a bioanalytical testing partner with comprehensive solutions and unwavering commitment to quality can help you bring safe and effective drugs to market with confidence.

Advancing biologics from start to finish is highly complex and full of challenges, requiring scientific strategies and implementation.

Discover a solution with nearly 50 years of excellence in solid oral dose manufacturing and packaging that has innovative facilities and skilled professionals to deliver trusted products worldwide.

Our extensive oncology expertise coupled with an end-to-end approach helps accelerate your clinical programs, giving you the confidence to bring breakthrough treatments to patients.