Newsletter | November 7, 2025

11.07.25 -- Powering Standards With Code: The Role Of Open Source In CDISC 360i

SPONSOR

Join the CRO Solutions Expo: Finding the Right Partner for Early-Stage Oncology Trials on Nov. 19, 2025. In just 2 hours, hear 15-minute presentations from leading CROs, compare Phase 1 & 2 oncology capabilities, and engage in live Q&A. Designed for clinical ops leaders, procurement teams, and oncology sponsors, this event helps you build a curated shortlist of CRO partners—faster, smarter, and without travel. Featuring insights from Clin.AI on CRO selection success.

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.

The Regional Site Manager Is The Swiss Army Knife Of Trial Monitoring

The Regional Site Manager (RSM) monitoring model eliminates numerous clinical trial risks by leveraging efficient, start-to-finish site management by a single, expert point of contact.

A New Blueprint For Transforming Feasibility And Recruitment

Clinical trials often fail due to poor feasibility planning. A new AI-powered approach bridges protocol design with real-world patient access to improve enrollment success.

SPONSOR

Webinar: Rethinking effectiveness in clinical operations: balancing tradeoffs in an era of disruption

Discover how leading pharma organizations are rethinking their clinical operating models to drive innovation, efficiency, and agility. Join PA Consulting’s experts as they explore R&D structure choices, outsourcing strategies, and the impact of digital transformation on speed, cost, and quality. Gain practical insights to optimize decision-making and boost clinical operations performance in a rapidly changing landscape. Click here to learn more.

CLINICAL DATA MANAGEMENT & ANALYTICS

Powering Standards With Code: The Role Of Open Source In CDISC 360i

Discover how to implement CDISC standards in automated research data pipelines that are fast, scalable, and reliable.

Strategies For QA Professionals In Life Sciences

Explore challenges QA professionals face in document reviews and expert strategies to boost accuracy, streamline workflows, and ensure compliance with evolving regulatory standards.

Eliminate Clinical Trial White Space With The Right AI Strategy

Learn how sponsors and CROs are using agentic AI to eliminate the unproductive time caused by manual, sequential processes and fragmented data systems.

Can AI Move Beyond Surface-Level Insights: Part Two

Yochi Slonim, cofounder and CEO of Anima Biotech, explores how AI is evolving from generating ideas that anyone can access to building disease models that leverage proprietary data.

Digging Through The Hype: Can AI/ML Assist Clinical Development?

AI has great potential to enhance the efforts of your team members by accelerating data interactions. Watch this webinar and discover how AI can improve clinical trial outcomes and data management.

Driving The Next Wave Of Innovation In Clinical Data Management

To better accommodate growing clinical data volume and decentralized trials, many organizations are activating AI-enabled trial tools to enhance workflows and ensure real time data review.

Tackling Special Characters With SAS And R

Hidden non-printable characters often compromise study data integrity. Automated SAS and R tools ensure your datasets are clean, reproducible, and ready for regulatory submission, saving crucial time.

Real-World Data And Real-World Evidence

As clinical research evolves, RWD and RWE play a crucial role in complementing conventional randomized controlled trials (RCTs) by capturing insights that accurately reflect clinical practice.

The Industry’s First And Only Unified Platform For RWE Generation

Built on interoperability, intelligence, and regulatory rigor, Castor Catalyst provides the infrastructure to connect, the automation to scale, and the expertise to turn complex data into actionable evidence.

What Our Portal Does For Sites, Sponsors, And Patients

Clinical trial portals should reduce friction—not add it. Streamlined tools empower sites, support patients, and give sponsors visibility without micromanagement or unnecessary complexity.

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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