Newsletter | August 29, 2025

08.29.25 -- What Clinical Operations Should Know About Medical Affairs And MSLs

SPONSOR

Smart Sourcing: IRT/RTSM Technology Showcase

Join us on September 24, 2025, for a free virtual expo tailored to clinical teams evaluating IRT/RTSM platforms. Get live 15-minute demos, real-time Q&A, and side-by-side comparisons from top vendors. Ideal for Clinical Ops, Trial Supply, Data Management, and Procurement professionals, this event helps accelerate vendor selection and streamline study planning.

TRIAL MONITORING

What Clinical Operations Should Know About Medical Affairs And MSLs

Guest Column | By William Soliman, Ph.D., BCMAS

Having spent years in medical affairs and leading MSL teams, William Soliman, Ph.D., BCMAS, explores how clinical operations and medical affairs thrive in collaboration or struggle in silos and offers tips for better partnerships.

From Study Feasibility And Recruitment To Trial Monitoring

Product | Southern Star Research

Our team of experts will guide you through the clinical trial process using a proactive and collaborative approach, ensuring that your stakeholders are always informed.

SPONSOR

The Rare Trials Summit brings together biopharma leaders, researchers, patient advocates, and regulators to accelerate the development of rare disease therapies. Over two days in Boston, attendees will engage in high-impact sessions, interactive workshops, and networking designed to spark collaboration, solve operational challenges, and improve patient outcomes—turning innovative ideas into actionable strategies for rare disease clinical trials.

CLINICAL DATA MANAGEMENT & ANALYTICS

EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance

Guest Column | By Peter H. Calcott, Ph.D., FRSC, Calcott Consulting LLC

The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

Clinical Trials In The Age Of Cost Caps

Article | By Charlie Paterson, PA Consulting

On February 7, 2025, the NIH introduced a pivotal policy (NOT-OD-25-068), capping indirect cost recovery at 15% for research grants.

6 AI And Machine Learning Considerations For Trial Management

Infographic | PPD Clinical Research Business of Thermo Fisher Scientific

Are you considering integrating AI and ML into your workflow? These six considerations will help you plan out an effective trial.

Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration

Case Study | Ideagen

A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.

Distribute, Monitor, And Exchange Study Documents With Every Site

Product | Florence Healthcare

Effortlessly distribute, monitor, and exchange study documents with every site—wherever they work, whenever they need it.

Data Management: Turning Data Into Insights

Product | Catalyst Flex

At Catalyst Flex, we understand that clean data is the foundation of successful analyses.

What If Your Study Portal Actually Helped Patients?

Product | Scout

Patients shouldn’t have to jump through hoops. Discover an innovative portal that lets them handle travel and reimbursement directly—securely, simply, and without extra calls to the site.

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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