Newsletter | November 12, 2026

11.12.26 -- AI, Trial Compliance, And HEOR Are Testing Operational Readiness

WHERE TRIAL ACCOUNTABILITY STARTS

How Trial Disclosure Noncompliance Fell From 73% To 2.4%

By John Oncea, Chief Editor, Clinical Tech Leader

Yolanda Davis explains how defined ownership, tracking, and standardized workflows cut a university’s trial disclosure noncompliance in two years.

 

How AI Governance Supports Responsible Trial Adoption

By John Oncea, Chief Editor, Clinical Tech Leader

Velocity leaders explain how clean data, a governance council, and human review help teams evaluate AI tools without making oversight a barrier to adoption.

Why Biostatisticians Need A Role Before Trial Enrollment

By John Oncea, Chief Editor, Clinical Tech Leader

A Pfizer and Cytel veteran explains why early statistical input matters and how outsourced contracts can limit collaboration during trial design.

AI, EVIDENCE, AND CHANGE UNDER OPERATIONAL PRESSURE

Why Clinical Trial AI Needs Workflows, Not Just Models

By Abraham Gutman, AG Mednet

AI outputs only help when teams can review, act on, and document them. Explore how governed workflows connect automation with human accountability.

HEOR In 2026-27: AI, RWE, And Eight More Trends To Watch

By ISPOR—The Professional Society for Health Economics and Outcomes Research

Drawing on input from 740 professionals, ISPOR examines how AI, RWE, pricing, and evolving HTA approaches are reshaping healthcare decisions.

Why Protocol Amendments Need Change-Ready RTSM Systems

By Endpoint Clinical

Explore how structured governance, testing, and traceability help teams manage amendment impacts across randomization, supply, sites, and data.

Four Vendor Oversight Priorities For Trial Teams To Track

By Kalyan Obalampalli, ClinAI

Focus vendor oversight on time, money, quality, and relationships. Learn how actionable metrics help teams monitor performance without unnecessary complexity.

CRF Validation: Reduce Trial Rework Without Burdening Sites

By Crucial Data Solutions

Early planning, clear edit checks, and risk-based validation help teams prevent data discrepancies without creating unnecessary site workload.

TOOLS FOR MONITORING, PATIENT SUPPORT, AND SOURCE DATA

Agentic Clinical Monitoring In Action: More Than A Copilot

Medable

Patient Payments And Travel Tools To Reduce Site Burden

Suvoda

CRIO Central eSource For Standardized Trial Data Capture

CRIO