Newsletter | November 4, 2026

11.04.26 -- Feasibility Isn't Just A Technology Problem

SPONSOR

How Well Is Your CRO Governing Your Clinical Data?

Outsourcing clinical trial execution does not remove a sponsor’s responsibility for the data. Learn how to assess a CRO’s data governance, from accountability and data integrity to issue management, system controls and inspection readiness, using a structured, risk-based approach. Read the article.

DECENTRALIZED TRIALS

RFK Jr. Wants Every American Wearing A Wearable. How Can Pharma Build A Business Around It?

The timing is now for pharma to be all-in on using wearables as their new business strategy, says Digital Medicine Society (DiMe) Director of Partnerships Smit Patel, PharmD.

At-Home Clinical Trials: When At-Home Ophthalmic Exams Make Sense

At-home ophthalmic exams in clinical trials improve patient accessibility, reduce site burden, and maintain data integrity, enabling decentralized research without sacrificing quality or compliance.

SPONSOR

Webinar: Vendor Selection to Last Invoice: Lessons in Clinical Financial Management

Clinical trial finances involve far more than choosing a CRO. From vendor selection and budget negotiations to forecasting, change orders, and final invoices, every stage can impact efficiency and financial control. Join Crescent Biopharma and Clin.AI experts for practical strategies to improve financial visibility, manage budgets, strengthen vendor collaboration, and make smarter decisions across the clinical trial lifecycle. Click here to learn more.

TRIAL MANAGEMENT

Feasibility Isn't Just A Technology Problem

Vanessa Gertsen acknowledges the growing number of technology and AI tools available for feasibility, but brings the discussion back to the realities facing patients and sites. Trial participation requires a major commitment from both, while sponsors are often competing for the same sites and patients.

Why Do Mid-Study RTSM Software Changes Take So Long?

Explore the root causes of slow, risky RTSM change control, focusing on diagnosing the problem so sponsors can better evaluate RTSM software and processes before the next mid-study change.

The Phase 2 Endpoint Dilemma

Phase 2 neuro endpoints can miss subtle change. Learn when composites help or hinder, how to align cognition, function, and biomarkers with real-world data for go/no-go decisions.

The Answer To Advance Your Allogeneic CAR-T Cell Clinical Trial

Dozens of assays, a shifting sample analysis plan, and a network of specialty labs: see how coordinated oversight kept an allogeneic CAR-T trial on track.

Understanding Subjective Outcome Measures In HAP Studies

Understanding how a participant "feels" is essential for drug safety. Explore how subjective measures and specialized training provide the data needed to evaluate human abuse potential.

Clinical Trial Supply Services: End-To-End Patient-Ready IMP Delivery

At the center of every clinical trial is a patient waiting for a treatment to arrive safely, securely, and on time. Clinical trial supply services make that possible.

Execute And Understand Your Study Within One Connected System

Design, build, simulate, and analyze clinical studies in one connected system. Embedded intelligence supports the full lifecycle, from protocol development to closeout.

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