Newsletter | August 8, 2025

08.08.25 -- 5 Cs For Responding To FDA-483s — Strategies For Effective Compliance And Resolution

SPONSOR

Partnerships with Sites, held September 15, 2025, in Philadelphia, is purpose-built for clinical operations professionals looking to elevate collaboration with research sites. Through real-world case studies and strategic discussions, attendees will gain tools to reduce burden, accelerate enrollment, and build stronger sponsor-site relationships. Use code LSL20 for 20% off your registration.

CLINICAL DATA MANAGEMENT & ANALYTICS

More Personalized, Precision Medicine Needed In Psychiatry Clinical Trials

Arrivo Bioventures' Joel Raskin, MD, and Greg Rigdon, Ph.D., discuss the importance of personalized and precision medicine in psychiatry clinical trials.

Impact Of Data Concerns In Neurological Clinical Trials: Quality Matters

This is Part 1 of a 3-part series demonstrating how robust data analytics can address the real-world implications of data quality issues that affect patients waiting for effective treatments.

Phase 4 Trials: A Critical Component Of Post-Marketing Insight

Uncover how Phase 4 trials play an essential role in gathering additional real-world data on the treatment’s performance over a longer period of time and in more diverse patient populations.

Fomenting A Culture Of Analytical Excellence In Clinical Development

Building an "analytics culture" in clinical research requires striking a balance between fast, flexible technologies and the right support for trial teams working to integrate these solutions.

Customer-Centric, Cost-Effective, Quality-Focused Solutions

Learn about Medical Information (MI) Services that deliver innovative, AI-driven, and globally scalable solutions to meet the evolving needs of pharmaceutical companies.

TRIAL MONITORING

5 Cs For Responding To FDA-483s — Strategies For Effective Compliance And Resolution

Former FDA Director of Bioresearch Monitoring Division (West) Eric Pittman, MBA, shares his top five tips for responding to FDA-483s.

The Evolving Role Of AI And Innovation In Cardiac Monitoring

In this presentation, the panel of experts focuses on the changes AI has brought to cardiac monitoring data during clinical trials and addresses the skepticism over the use of new innovations.

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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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