Newsletter | July 11, 2025

07.11.25 -- Unsure About The New ICH Guidelines? TransCelerate Debuts 13 Tools To Help

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As clinical trials grow increasingly complex, traditional monitoring models are showing their cracks. Overextended CRAs, inconsistent site engagement, and reactive oversight can lead to delays, data quality issues, and strained site relationships. Join clinical operations experts for a candid conversation about what's not working in today's trial monitoring—and what could.

CLINICAL DATA MANAGEMENT & ANALYTICS

Breaking Down The FDA's Latest Guidance On Electronic Systems In Clinical Investigations

In October, the FDA took a significant step forward by releasing a new Q&A guidance clarifying the use of electronic systems, e-records, and e-signatures in clinical investigations.

Understanding How To Build And Leverage A DSMB Statistical Plan

Get an overview of the essential components involved in providing independent statistical center support for a data safety monitoring board (DSMB), also known as a data monitoring committee (DMC).

Cloud vs. On-Premises In The Pharmaceutical Industry

Many pharmaceutical companies are considering implementing cloud solutions to address the growing complexity of traditional clinical trials, fragile supply chains, and increasing regulatory pressures.

Top 9 AI Implementation Strategies For Pharmacovigilance

By following these nine strategies, organizations can implement AI in pharmacovigilance responsibly, ensuring systems that are aligned with the goal of improving patient safety and public health outcomes.

5 Ways Lab Data Can Help Commercialize Your Therapy

In this text, we delve into five pivotal insights for leveraging lab data effectively.

Introduction To An End-To-End Clinical Data Science Platform

Watch to learn about an end-to-end clinical data science platform designed to streamline the rapid generation of deep insights from clinical trial data, enabling efficient delivery of crucial analyses.

A QMS Software That Enhances Operational Excellence

This modular SaaS solution is designed with the needs of quality managers in mind. It is trusted by more than 6,000 customers worldwide to digitize quality management and comply with industry standards.

The PPD Clinical Trial Forecasting Suite

An advanced AI-powered platform designed to revolutionize clinical trial planning and execution leverages deep learning and proprietary performance data to deliver highly accurate, real-time forecasts.

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CRAACO: Clinical Research as a Care Option will be held September 15, 2025, in Philadelphia. This one-day event brings together stakeholders from across the life sciences and healthcare ecosystem to align clinical research with patient care. Learn how leading organizations are improving trial access, accelerating enrollment, and advancing integration. Use code LSL20 for 20% off your registration.

TRIAL MONITORING

Unsure About The New ICH Guidelines? TransCelerate Debuts 13 Tools To Help

TransCelerate BioPharma's Tashan Mistree discusses 13 new tools created alongside the Association of Clinical Research Organizations (ACRO) to support ICH GCP E6(R3) adoption.

The Critical Role Of The Medical Monitor

Medical Monitors interact with nearly all functional roles on a study team and more experienced monitors often support and mentor less-experienced colleagues.

How DHTs Facilitate Widespread Outpatient Immunotherapy Treatments

An expert panel explores how the industry leverages digital innovation to manage immunotherapy risks and critical next steps toward deploying scalable, technology-driven CRS monitoring solutions.

The Key To Compliance, Patient Safety, And Risk Based Monitoring

eClinical technologies are becoming more commonplace in drug development. Uncover how digital solutions are helping sponsors improve efficiency and accuracy within their clinical trials.

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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