Newsletter | October 15, 2025

10.15.25 -- Mastering The Monitoring Visit: Key Tips For Site Success

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Join Clinical Leader on October 23 at 1PM ET for a virtual panel discussion on FSO or FSP? What Works, When, and Why. Registration is free with support from Catalyst Flex.

TRIAL MANAGEMENT

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.

Everest Group Life Sciences eCOA Peak Matrix Assessment 2025

Discover how digital platforms are revolutionizing clinical trials by improving data quality and patient engagement in this comprehensive market assessment.

Designing More Representative Trials Through Strategic Planning

Strategic planning for representative clinical trials improves outcomes, regulatory alignment, recruitment efficiency, and commercial value by ensuring study populations mirror real-world patients.

Leveraging Biomarkers In Early PK/PD Studies

Integrating biomarkers into early clinical studies is crucial to determine whether a new therapy engages its biological target, triggers the intended PD effects, and shows early signs of efficacy.

A Patient-Centered Approach For Advancing Rare Disease Trials

On your journey to developing and executing a successful rare disease trial, it is critical to focus on patient experience and accessibility from the earliest stages of trial design.

First In Human (FIH) Fact Sheet

For small or large molecules, simple or complex trials, we have the expertise, purpose-built Phase 1 facilities, and seamless processes to deliver quality with speed and ease.

Pharmacovigilance Quality Assurance & Inspection Readiness

Whether preparing for a product launch or entering a new market, we ensure your safety systems are compliant, efficient, and built to withstand regulatory scrutiny.

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DECENTRALIZED TRIALS

What The FDA Says About Investigator Responsibilities In DCTs

Learn exactly what the FDA says about the use of healthcare providers (HCPs), telemedicine, licensing, and practice standard requirements when executing a DCT.

Success In Vulnerable Patient Populations With Mobile Research Nurses

Dr. Steven Cummings highlights the role of PCM Trials certified mobile research nurses in making possible large-scale home-based clinical trial.

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You're receiving the Wednesday edition of the Clinical Leader newsletter, focusing on Decentralized Trials and Trial Management. 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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