Newsletter | January 23, 2026

01.23.26 -- How AI Is Rewriting The Future Of TMF And Clinical Quality

SPONSOR

Webinar: Embedding AI and Critical IRB Operations Data to Drive Intelligent Study Design

Study design is increasingly empowered by a rich and diverse array of data. New sources continue to emerge, fueled by advances in AI that enable the integration of information from literature, ClinicalTrials.gov, digitized protocols, and beyond. Join us for a dynamic discussion on how to critically evaluate and integrate these data streams into study design decisions. Click here to learn more.

CLINICAL DATA MANAGEMENT & ANALYTICS

Why HEOR Keeps Arriving Too Late — And How ClinOps Can Fix It

Rob Abbott, CEO of ISPOR, breaks down why HEOR timing keeps clashing with ClinOps timelines and offers practical ways to integrate value, evidence, and payer expectations much earlier in development.

Challenges Of EDC Solutions In Phase 1 And Phase 4 Clinical Trials

Learn how phase-specific EDC strategies can overcome early- and late-phase trial challenges while ensuring data continuity and success across the full clinical development lifecycle.

The Case For A New Paradigm In Geographic Atrophy Clinical Trials

Explore a new framework for GA clinical development that integrates genetic profiling, novel biomarkers, and predictive analytics.

Advancing Dose Escalation Strategies With Bayesian Modeling

A biotechnology sponsor engaged a CRO while developing a novel oncology therapy design and executed a multicenter, open-label Phase 1/2 dose escalation and expansion study in advanced solid tumors.

Simple Description Of Clinical Analytics

Without teamwork, the best solutions still fall short. Unlock your clinical data's potential and transform chaos into clarity by starting with clear questions, adapting to insights, and fostering collaboration.

A New PV Ecosystem: Automation, AI, And Continuous Improvement

As Pharmacovigilance (PV) evolves into a proactive, value-driven discipline innovations like robotic process automation and artificial intelligence help improve efficiency and data utility.

Generate Regulatory-Grade, RWE With Speed And Efficiency

For teams managing real-world evidence or post-market studies, automation offers a scalable solution to streamline workflows, maintain compliance, and accelerate decision-making.

Document Review Integrations And Technology Partners

Achieve seamless collaboration and enhance your document review process through a partnership that brings you strategic alliances with leading technology providers across the life science industry.

TRIAL MONITORING

How AI Is Rewriting The Future Of TMF And Clinical Quality

Discover how AI is transforming the TMF from a reactive repository into a proactive, intelligent co-pilot for clinical trials.

Key Items Auditors Look For When Reviewing An Investigator Site File

Gain insight on how to prepare investigator site files (ISF) for audits and what teams should consider when looking to enhance efficiency and compliance.

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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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