Newsletter | December 5, 2025

12.05.25 -- GCP Oversight Simplified: A Quick Guide

SPONSOR

Clinical trials drive medical progress, and SCOPE brings the community together to advance them. Returning February 2–5, 2026, in Orlando, SCOPE builds on 2025’s record 4,500+ attendees, 630 speakers, and 300 exhibitors. The 2026 program features 30 tracks, new additions in Market Access, Safety, and Therapeutic Areas, major awards, and expanded coverage of AI, patient-centric design, site engagement, and trial operations. SCOPE unites global leaders shaping the future of clinical research. www.SCOPEsummit.com

CLINICAL DATA MANAGEMENT & ANALYTICS

How AI Is Transforming Patient Stratification

Discover how AI tools can help stratify or group patients into subtypes that respond differently to treatment.

Using AI Tools In Hepatology Drug Development

Explore how AI can help overcome key challenges in hepatology trials — from site selection and patient matching to data integration and engagement — while ensuring diversity, privacy, and transparency.

Rare Neurological Disease Trials: Smarter Design

Rare neurological trials face ethical and operational barriers. Natural history studies and external control arms provide accepted, practical alternatives to de-risk development and accelerate patient access.

The AI Revolution In Clinical Trials

AI is reshaping clinical trials by accelerating patient recruitment, optimizing protocol design, and improving data quality—driving faster, more efficient, and more inclusive research outcomes.

Rescuing Data Integrity: A Swift Transition And Quality Transformation

Uncover how a collaboration supported timely progress toward key study milestones, enabling smoother execution and more dependable output across data management and statistical activities.

Unlock Peak Performance: AI-Powered Study Start-Up And Execution

Speakers delve into how AI is reshaping every stage of the clinical trial journey — from designing smarter, more feasible protocols to streamlining study start-up and execution.

6 Key Ways Real-World Data Is Advancing Colorectal Cancer Therapies

Real-world data (RWD) is transforming colorectal cancer research by complementing traditional clinical trials, accelerating drug development, and improving patient outcomes.

Wrangling Data With AI To Help Shape The Industry's Future

Learn how biotech firms can harness emerging technologies and other AI-driven innovations to shape the future of data-powered healthcare and scientific discovery.

Gain Instant Access To HEOR Education With On-Demand Programs

The ISPOR Education Center provides access to Health Economics and Outcomes Research (HEOR) education with on-demand programs delivered through a personalized and flexible learning platform.

Regulated Document Review

A structured, stable, and robust environment for collaboration enables secure real-time document review, co-authoring, and redaction in order to shorten the document review process by up to 65%.

How AI Is Setting A New Standard In Clinical Development

Learn how to adopt artificial intelligence in practical, measurable ways, from protocol feasibility and cohort modeling to clinical trial disclosure and transparency.

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.

Clinical Analytics Solutions To Unify Your Data

Increasingly complex clinical trials require a fast, flexible data and analytics platform. See how access to real-time data is able to drive analytic efficiencies and bring new drugs to market faster.

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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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