Newsletter | November 14, 2025

11.14.25 -- Why CRA Proficiency Needs A Boost From Better Assessment And Training

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Spotlight the Best in CRO Partnerships—Share Your Voice!

Help shape the future of CRO excellence! Take part in the 2025 CRO Leadership Awards Survey, conducted by Tufts CSDD and Clinical Leader. Your confidential feedback will determine the top CROs in project management, services, culture, and more. Winners will be celebrated through Clinical Leader events—don’t miss your chance to spotlight outstanding collaboration in our industry!

CLINICAL DATA MANAGEMENT & ANALYTICS

Why AbbVie Moved Risk Assessment To The Draft Protocol Stage

Ann Hale, Head of Study Risk Management and Central Monitoring at AbbVie, discusses the company's shift toward conducting risk assessments earlier in the protocol development process using cross-functional teams. She emphasizes the importance of data criticality assessments and asking the fundamental question "What is truly critical?" to identify genuine showstoppers versus nice-to-have data points.

Reclaiming Your Time: Save Thousands Of Hours With Agentic AI

Reimagine the clinical trial lifecycle by automating slow, manual workflows, removing barriers in the clinical process, and introducing new ways to achieve R&D goals like never before.

What We Learned At SCDM 2025 — And How To Act On It

SCDM 2025 spotlighted six key shifts in clinical data management — from explainable AI to ICH-M11 — offering actionable strategies for teams embracing digital transformation.

Designing More Precise Clinical Trials Using AI-Driven Analytics

Clinical trials face staggering failure rates and inefficiencies. Discover how AI and real-world evidence streamline patient recruitment and trial design to help reshape the future of clinical research.

The Clinical Imaging Strategy That Safeguards Ocular Endpoints

GLP-1 and neurology trials depend on detecting subtle retinal or neuro-ophthalmic changes early. By planning an imaging strategy upfront, sponsors can de-risk studies and protect critical endpoints.

How FAIR Data Principles Deliver Clinical Success

Prioritize data management that adheres to FAIR principles — findable, accessible, interoperable, and reusable — to gain operational insights that enable quick decisions and ensure participant well-being.

Timely Lab Data To Inform Outreach To Healthcare Professionals

Learn how you can leverage a system that offers flexible data delivery formats and integration into commercialization workflows while also ensuring HIPAA-compliant deidentified data for patient privacy.

Computer Systems Assurance And Validation

Computer System Validation to cover all your GMP, GLP, GCP, and QA/QC software applications. CompliancePath currently has 30+ active projects globally supporting clients in CSV/CSA compliance.

Medidata Clinical Data Studio: AI-Assisted Data Reconciliation

AI supports clinical data managers by streamlining reconciliation of adverse events, medical history, labs, and medications — reducing manual effort and improving data accuracy.

The PPD Clinical Trial Forecasting Suite

An advanced AI-powered platform designed to revolutionize clinical trial planning and execution leverages deep learning and proprietary performance data to deliver highly accurate, real-time forecasts.

TRIAL MONITORING

Why CRA Proficiency Needs A Boost From Better Assessment And Training

CRAs intend to fulfill clinical research’s commitment to patient safety. Yet, some fall short of true proficiency, and Gerald DeWolfe contends better evaluations and training can help.

Understanding How To Build And Leverage A DSMB Statistical Plan

Get an overview of the essential components involved in providing independent statistical center support for a data safety monitoring board (DSMB), also known as a data monitoring committee (DMC).

Improving Clinical Trial Performance Through Central eSource

See how a top five pharmaceutical company leveraged our esource platform to enhance site performance, improve data consistency, and enable remote monitoring.

CHOOSE YOUR OWN ADVENTURE

You're receiving the Friday edition of the Clinical Leader newsletter, focusing on Clinical Data Management & Analytics and Trial Monitoring. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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