Newsletter | March 7, 2025

03.07.25 -- What Should You Ask The FDA About AI

TRIAL MONITORING

Why Sponsors Must Check For Site GCP Adherence During Feasibility Studies

GCP consultant Donatella Ballerini explores how adherence to GCP influences site feasibility, shaping the success and credibility of a clinical trial.

RSMs: The Swiss Army Knife Of Clinical 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.

Cytokine Release Syndrome Monitoring

Here we introduce an innovative risk-monitoring solution aimed at mitigating Cytokine Release Syndrome (CRS), a critical complication in immunotherapy that often leads to prolonged hospitalization.

CLINICAL DATA MANAGEMENT & ANALYTICS

What Should You Ask The FDA About AI

Understanding some of the common questions the FDA gets about AI may help you when interacting with the agency.

What Do Biostatisticians Think Of The ICH E9(R1) Addendum?

Gain insights from Kristina Bondareva, Head of Biostatistics at OCT Clinical, on the significance of the Addendum and the importance of adopting the estimand framework in clinical trials.

FDA Guidance On The Use Of DMCs In Clinical Trials

Gain an overview of FDA guidance on the use of Data Monitoring Committees (DMCs) in clinical trials and their critical role in safeguarding patient safety and ensuring unbiased decision-making.

How SaaS Unlocks New Possibilities For Life Science Organizations

The rise of SaaS (software-as-a-service) has transformed industries, including life sciences, by enabling new possibilities. See how it’s already helping life science organizations around the world today.

Accelerate Your Operations With Smarter Trial Management

This cloud-based solution centralizes clinical and operational data to improve the efficiency and oversight of clinical trials.

The SaaS Clinical Data Science Platform

Learn about a comprehensive platform used to enable the rapid delivery of clinical insights that inform both clinical and operational study decisions.

Data Licensing For Clinical Trial Planning

Quest Diagnostics' data licensing solutions enhance clinical trial planning by optimizing site selection, investigator identification, and regulatory compliance.

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)

Learn more about our personalized newsletters here.

Connect With Clinical Leader: