Newsletter | October 31, 2025

10.31.25 -- Mastering The Monitoring Visit: Tips For Site Success

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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

RWE Is Growing Up, And Here's Why That Matters

Real-world evidence is shifting from the margins to the mainstream of drug development, but data quality, trust, and regulatory clarity remain hurdles. ISPOR is helping set the standards to guide its future.

Data Distortions: When Statistics Can Lead Us Astray In Drug Safety

Post-marketing signals and AE frequency comparisons need careful interpretation. Discover how confounding factors and misunderstood statistics often mislead drug safety professionals.

Bottlenecks To Breakthroughs: AI Is Transforming Translation Timelines

Take a deeper look at AI-enabled translations and uncover how they are able to drive a remarkable 43% reduction in overall translation timelines.

Real-World EHR Data For Deeper Insights Into Ophthalmic Conditions

In ophthalmology research and drug development, reliance on broad ICD-10 codes often obscures critical clinical details that are essential for precise patient stratification and safety assessment.

Advanced Technology And The Expertise Of A Highly Skilled Team

Explore a cutting-edge service in powder blending, encapsulation, tablet compression, and on-site laboratory testing that meets the highest standards to ensure quality and compliance.

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TRIAL MONITORING

Mastering The Monitoring Visit: Key Tips For Site Success

The ACRP Atlanta Chapter recently hosted a Lunch-n-Learn session on “Mastering the Monitoring Visit: Key Tips for Site Success.” The conversation highlighted the shared goal of CRAs and CRCs: ensuring compliance, protecting data integrity, and making monitoring visits a collaborative — not adversarial — experience.

Strategies For Efficient Clinical Supply Management And Forecasting

Drive excellence in clinical trials by utilizing forecasting to better plan clinical supply budgets and project timelines, and identify potential supply-related issues before they negatively impact a study.

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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