Newsletter | October 15, 2026

10.15.26 -- How Can You Be Sure You Found The Right CRO Partner?

SPONSOR

 

Rethinking Early Phase CNS Strategy for the Single-Phase 3 Era

Explore the strategic implications of the FDA’s evolving single-Phase 3 approval paradigm and how thoughtful Phase 1 and 2 trial design can help position CNS programs for regulatory and investor success. Read the Publication.

REGULATORY COMPLIANCE

 

Clinical Supply Systems Need IT General Controls

Guest Column | By Eshaan Jain

Validating a clinical trial system does not prove it stays trustworthy. IT general controls can protect data, supply decisions and patient safety long after go-live.

 

Initial IRB Submission: 7 Fundamentals Of Success

Infographic | BRANY

The initial IRB submission process can involve common challenges. To help you overcome these obstacles, discover seven fundamentals you should know about a successful initial IRB submission.

 

How Sponsors Are Responding To FDA's RTCT Request For Information

White Paper | Paradigm Health

Let's take a look at where continuous, real-time regulatory review can meaningfully speed drug development, and where it likely won't help much.

 

Relieving Pressure During Preparation Of A High-Volume sNDA

Case Study | Veristat, Inc.

Managing a complex sNDA under pressure? See how one sponsor achieved an early FDA submission through coordinated publishing, regulatory strategy, and flawless execution.

 

Transforming PAH Trials For Patient-Centric Care

Article | By Nicole Zandy and Scott Oakes, IQVIA Biotech

PAH trials need patient-focused strategies. See how innovative designs, digital tools, and real-world data can simplify recruitment, reduce complexity, and improve outcomes in this challenging space.

 

A More Intuitive IRB Submission Experience

Video | Univo IRB

Gain insight into a more intuitive IRB submission experience that can help reduce friction, improve transparency, and support today’s virtual research workflows.

SPONSOR

 

Webinar: Operationalizing Adaptive Design for FDA's One-Trial Era

The FDA’s 2026 One-Trial pathway is changing how sponsors approach pivotal trial design. In this webinar, Veristat’s adaptive design experts explore the statistical frameworks, regulatory strategies, and practical considerations for building a defensible single pivotal trial. Hear a real-world case study demonstrating how adaptive design can reduce development timelines and costs while maintaining trial quality, offering insights for today’s clinical development teams. Click here to learn more.

OUTSOURCING MODELS

 

Can Your Team Coordinate The CRO Model You've Chosen?

Guest Column | By Manu Joshi, Beroe, and Suzanne Vyvoda, Concordia BioStrategies

Choosing the right CRO model matters less than a sponsor’s ability to coordinate it. Here’s how to match outsourcing strategy to internal capacity.

 

The Bioanalysis CRO Selection Checklist Every Sponsor Should Use

Article | Dash Bio

Choosing a CRO requires more than proposals. Assess reliability, automation, GLP rigor, scientific engagement, pricing clarity, and capacity to find partners who deliver defensible data on real timelines.

 

Finding The Right CRO Partner For Early-Stage Oncology Trials

Video | ClinAI

Discover how a data-driven CRO selection framework can replace manual processes, minimize bias, and build stronger, more collaborative sponsor–vendor relationships.

 

Dedicated Community Oncology Sites

Video | Flourish Research

Rapid activation, strong referral partnerships, diverse patient access, and specialized immunotherapy infrastructure are reshaping oncology research.

 

Delivering Oncology Clinical Trial Excellence Worldwide

Datasheet | Worldwide Clinical Trials Oncology

Accelerate oncology programs with deep therapeutic expertise and global scale. Master the complexities of ADCs and cell therapies through agile execution and high-retention project teams.
Connect With Clinical Leader: