Newsletter | September 24, 2026

09.24.26 -- Why ING Feels Different

SPONSOR

 

Webinar: Speed Meets Precision: Accelerating Oncology with Smarter Data

Oncology trials are generating more complex data than ever, increasing pressure on sponsors to move faster without compromising quality. Join oncology leaders as they explore how real-time data, AI-enabled analytics, and connected teams are transforming clinical development. Discover practical strategies for modernizing data flow, accelerating decision-making, and navigating evolving expectations, including the FDA’s Project Optimus, with greater speed, confidence, and agility. Click here to learn more.

OUTSOURCING MODELS

 

A Sponsor Playbook For Matching AI Use Cases To Readiness, Risk, And ROI

Clinical technology consultant Karen Maduschke explains why your next AI investment should solve a problem you can articulate, with data you can access, in a process you can change.

 

The Rise Of Chinese Biotechs And The Global CRO Question

As innovative therapies move beyond home markets, early planning across regulators and geographies helps avoid costly delays and protect trial budgets.

 

The Hidden Cost Of CRO Change Orders And How To Manage Them

Improve budget oversight, forecast costs more accurately, and maintain a clear audit trail to minimize surprises and streamline CRO change orders.

 

A CRO Built For Early-Phase Research Excellence

Discover how specialized expertise, innovative technology, and purpose-built resources can come together to accelerate early-phase clinical research and deliver quality, efficient outcomes.

 

Your IRB, Simplified: Fast, Friendly, And Focused

IRB approval does not have to be defined by delays or confusion. Learn how expert guidance, regulatory support, and modern technology can help research teams move forward with greater efficiency.

 

Biotech-Tailored Clinical Development

Strategic planning, data-driven decisions, and global coordination accelerate clinical timelines while ensuring quality. Explore risk-based monitoring and practical ways to overcome complexity.

REGULATORY COMPLIANCE

 

Why ING Feels Different

I’ve attended enough clinical trial conferences to know how similar they can feel. ING is different. Its Dive Teams, WhaleTank, and candid conversations are designed to get attendees participating, not just listening. This year, I’m especially interested in an off-the-record regulatory panel that could tackle some of the biggest changes facing clinical research.

 

Psychedelic Therapeutics: A Regulatory Inflection Point In Mental Health

A 2026 executive order is fast-tracking psychedelic therapies for depression, PTSD, and addiction. Understand what this regulatory shift means for your next clinical trial.

 

How Operation TrialBlazer Effects RTSM And Clinical Trials

Learn how evolving trial designs are changing RTSM requirements and driving demand for greater flexibility, traceability, and execution quality.

 

Barcode-Driven Verification: Enhancing Compliance

Investigational products present a distinctly high-risk environment for labeling and barcoding. Explore best practices for barcoding solutions that allow for improved medication safety in clinical trials.

 

Strategic ADC Development In A Shifting Regulatory Landscape

As ADC development grows more complex, sponsors must align safety, dose optimization, global trial design, regulatory strategy and CMC readiness early to reduce risk and accelerate approval.

 

Fast-Track Innovation, Address CMC Challenges In Expedited Pathways

Learn to overcome solubility challenges and utilize flexible development strategies to transition innovative treatments from early-phase trials to commercialization while ensuring patient safety.

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