Newsletter | January 23, 2026

01.23.26 -- Why The EU Biotech Act Matters To The U.S.: A Clinical Perspective

FOCUS ON CLINICAL TRIALS

Why The EU Biotech Act Matters To The U.S.: A Clinical Perspective

The EU Biotech Act has international implications, especially for U.S.-based biotech sponsors developing advanced therapy medicinal products (ATMPs, also called cell and gene therapies), oncology therapies, or other high-complexity modalities. 

The Defensiveness Trap In Vendor Selection And Management

In clinical research, sponsor–vendor relationships are often framed as negotiations. Yet while both sides want to achieve a successful study, the process often becomes a tug-of-war.

Clinical Analytics Use Cases For AI

Automating FDA data validation rules and analyzing audit trail data can significantly reduce fraud and predict areas of concern. Discover how these advancements can transform your clinical trials.

The Strategic Advantage Of Australia And Asia For U.S. Biotechs

This expert panel explores how Australia, Taiwan, and South Korea provide a strategic advantage in conducting early, mid, and late-phase oncology trials.

Comply With The New NIH Transparency Rules For r/sNA Molecule Research

Review new transparency requirements for NIH-funded institutions engaged in research involving r/sNA molecules and regulations for Institutional Biosafety Committees (IBCs).

From Missing To Meaningful: Solving EHR Data Gaps

When data is missing or delayed, it can slow down trial progress. Improving EHR data quality strengthens clinical research and ensures faster access to life-changing therapies for patients in need.

Gain Quantitative ROI With DCTs For Patient Recruitment

Through dedicated staffing, operational oversight, and collaboration with site teams, see how a struggling cardiology study transformed into a revitalized recruitment effort.

An Integrated Approach To Biostatistics, Data Management, And Programming

By aligning biometrics expertise with advanced technologies and global regulatory standards, sponsors can optimize resources, ensure patient safety, and bring transformative therapies to market faster.

CLINICAL TRIALS SOLUTIONS

Connecting Highly Qualified Patients To Clinical Trials - Quest Diagnostics

Data Integrity Drives Every Step Of Your Clinical Trial - Biorasi

Recruitment Strategies: A Behind The Scenes Look - CHDR

FOCUS ON SUPPLY CHAIN

Flexible Freeze Containers In Gene Therapy Manufacturing

With each batch of cell and gene therapy product representing a wealth of lifesaving potential, this biopharma company needed the right packaging solution for its relatively new therapy applications.

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