Newsletter | May 26, 2026

05.26.26 -- Human-In-The-Loop In AI Validation And Control

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Reducing Avoidable Protocol Amendments By Anticipating Operational Pitfalls Hidden In Clinical Trial Design

Protocol amendments are often treated as inevitable, yet operational trial data reveals that many follow predictable patterns tied to early study design decisions.  Learn how amendment drivers vary across therapeutic areas and how those changes impact execution, patient burden, site workload, timelines, and study costs.

CLINICAL TRIAL TECHNOLOGY

Human-In-The-Loop In AI Validation And Control: From Principle To Practice

Guest Column | By Donatella Ballerini

Explores how human-in-the-loop oversight can move from principle to practice. with a risk-based framework for determining when HITL is required, how the human role should be defined, and what organizational factors influence its effectiveness.

A New Approach To The Complex Clinical-Trial Ecosystem

Article | IQVIA Technologies

To navigate the growing number of vendor portals required for clinical trials, sites are seeking a vendor- and sponsor-agnostic solution to enable single sign-on and study organization.

A Guide To Digital Endpoints In Respiratory Diseases

White Paper | Ametris (formerly ActiGraph)

Learn how wearables and DHTs are alleviating the trial participation burden, increasing the likelihood of trial success, and enhancing the overall management of these conditions.

A Fair, Ethical Framework For Participant Payments In Clinical Trials

Article | Mural Health

Participant payments in clinical trials have long been fraught with inconsistency, raising questions about the role of IRBs, tax implications, and fair reimbursement structures.

Ensuring Timeliness, Completeness, And Quality With Digital Solutions

Article | Florence Healthcare

A well-maintained TMF, supported by digital solutions, is the backbone of successful clinical trials, improving trial management and readiness for audits or regulatory submissions.

From Complexity To Clarity: Automate eCOA Configuration With AI

Video | Medable

Clinical trials are more complex than ever, but building and launching global studies doesn’t have to be.

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The True Science Behind eCOA, Shaped By Patient and Site Insights

This webinar explores how eCOA strategies in clinical trials can better balance scientific rigor with patient and site realities. Through panel discussions, participants will examine patient burden, operational challenges, inclusive digital tools, and the meaning of “eCOA science.” The session advocates for collaborative protocol design that embeds patient and site insights to improve participation, data quality, and trial outcomes. Click here to learn more.

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