Newsletter | October 10, 2025

10.10.25 -- GCP Oversight Simplified: A Quick Guide

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Webinar: From Protocol to Execution: Unlock the Future of AI-Powered Clinical Trials

Unlock peak performance with Medidata’s AI-powered study start-up and execution solutions. This session reveals how Medidata transforms trials with centralized platforms, intelligent workflows, and complete visibility. Learn to accelerate start-up, eliminate silos, and align every task, team, and timeline. Don’t just start strong—finish faster with Medidata’s precision, consistency, and efficiency from first patient enrolled to last patient out. Click here to learn more.

TRIAL MONITORING

GCP Oversight Simplified: A Quick Guide

Discover practical, real-world strategies for sponsors to operationalize GCP oversight in a way that is collaborative, measurable, and scalable.

GLP-1 Ocular Safety Monitoring At Point-Of-Need

Regulators are sharpening their focus on ocular safety in GLP-1 receptor agonist trials following emerging evidence linking semaglutide to non-arteritic anterior ischemic optic neuropathy (NAION).

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Join Clinical Leader on October 23 at 1PM ET for a virtual panel discussion on FSO or FSP? What Works, When, and Why. Registration is free with support from Catalyst Flex.

CLINICAL DATA MANAGEMENT & ANALYTICS

Seriously … Are We Making Any Progress?

Ken Getz’s DPHARM talk revealed how ballooning data collection in trial protocols drives costs, delays, and site burden. New ICH E6 R3 guidance pushes for more flexible designs, but real progress will require collaboration — and restraint.

The Data Dilemma: Balancing Innovation With Trust In Healthcare

Despite frequent data breaches, patients remain willing to share their health data with trusted healthcare providers that prioritize transparency and ethical stewardship.

Accelerating Clinical Data Review With Traceable Workflows

Discover how streamlined workflows and enhanced collaboration between data managers and medical reviewers can boost clinical trial efficiency, improve data quality, and ensure patient safety.

Ten Ways To Solve Your Document Review Headaches In Life Sciences

Struggling with document chaos in life sciences? Join James Wilding to uncover smart strategies and tools that streamline reviews, boost compliance, and enhance collaboration.

Integrated Approach To Biostatistics, Data Management, Programming

By aligning biometrics expertise with advanced technologies and global regulatory standards, sponsors can optimize resources, ensure patient safety, and bring transformative therapies to market faster.

Simplify The Complexities Of RWE Generation

By accelerating your research processes, see how this will also help in achieving more reliable outcomes, ultimately supporting the development of effective treatments and therapies.

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  • 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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