Newsletter | April 3, 2025

04.03.25 -- UCB Reaffirms Importance Of Including Women In Clinical Research

REGULATORY & COMPLIANCE

As FDA's "Sex Differences" Guidance Reemerges, UCB Reaffirms Importance Of Including Women In Clinical Research

UCB Biopharma's Marie Teil explores reasons to prioritize women's inclusion in research and how FDA guidance is poised to support that endeavor.

Transforming Medicine: Strategies In CAGT Development

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

Improving ISR Success Rates In Bioanalysis Of Small Molecule Drugs

Leveraging incurred sample reanalysis (ISR) in your quality control helps your team mitigate risks, establish regulatory compliance, and instill confidence in your pharmacokinetic modeling.

Top-Tier University Stays Compliant With HRPP Assessment

Discover how one university was able to identify and resolve programmatic gaps in compliance with federal regulations and revitalize its Human Research Protection Program.

OUTSOURCING MODELS

Biopharma R&D Faces Productivity And Attrition Challenges In 2025

Evaluate VP of Thought Leadership Daniel Chancellor discusses trends for 2025 as the surge in R&D, coupled with rapidly evolving industry dynamics, presents a productivity and attrition challenge for the industry.

Build Vs. Buy Vs. Partner In Life Sciences: Making The Right Call

Discover when life sciences organizations should develop technology in-house, buy off-the-shelf solutions, or form strategic partnerships.

Tips And Tricks For Developing Rare Cancer Clinical Trials

Conducting clinical trials for rare cancers presents unique challenges, making a partnership with an experienced Oncology CRO crucial for overcoming hurdles and ensuring trial success.

Optimize CMC And Clinical Strategies For Injectable, Oral Peptide Drugs

Advances in peptide drug delivery have opened new opportunities for peptide drug products, with non-parenteral routes of administration — such as oral and nasal — now feasible.

Streamlining Phase I/II Oncology Trials: A Global CRO Partnership

Through strategic planning, adaptive trial execution, and proactive collaboration, TFS successfully navigated the complexities of this early-phase oncology study.

Flipping The Drug Development Industry On Its Head

This video dives into the obstacles of the traditional outsourcing relationship between CROs and sponsors, and how Altasciences has broken from tradition to offer an alternative model.

Sachet Packaging Solutions

Discover versatile, high-quality sachets for manufacturers and consumers with an ideal fill weight of 2 grams and above that is suitable for food or liquid formulas.

A People-First Culture: Are You Ready To Make An Impact?

With a focus on small and mid-sized biopharma companies, this premier CRO specializes in delivering innovative solutions in oncology and infectious diseases.

Oncology CRO Services

Biotechnology companies are facing increased challenges around participant recruitment and retention, lengthy timeframes and relatively high costs.

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