Newsletter | March 14, 2025

03.14.25 -- Using CtQ Factors To Identify The Critical Data For RBQM

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Webinar: Who’s In Charge of Your Trial? How to Ensure Effective Oversight and Leadership

Clinical trials in complex therapeutic areas require more than just a solid strategy—they demand proactive and engaged operational leadership from the sponsor side. Join our expert panel to discuss how an active and knowledgeable Clin Ops lead, in collaboration with an experienced outsourcing project lead, can drive informed decision-making, enhance efficiency, and ultimately ensure trial success. Click to learn more.

CLINIAL DATA MANAGEMENT & ANALYTICS

Are We On The Cusp Of A Quantum Revolution In Clinical Trials?

Though quantum computing is still in a nascent stage, life sciences companies are already investing in this technology to enhance predictive models, improve site selection, and find the right cohort.

Leveraging RWE To Support Market Access Decision-Making

Real-world evidence (RWE) is changing how new medications are evaluated for market access. Experts offer insights into how RWE informs payer decisions and product positioning.

Overcoming Issues Of Non-Enrolling Sites In Clinical Trials

Explore the challenges of non-enrolling sites in clinical trials, focusing on the benefits of leveraging artificial intelligence (AI) and machine learning (ML) in addressing those issues.

How AI Is Changing How Clinical Research Teams Work

AI in clinical research serves as a "digital colleague," enhancing workflows, accelerating data analysis, and empowering study teams with precision, and insightful solutions for better patient outcomes.

5 Benefits Of Using A Study Management Tool

See how study management tools simplify clinical trial management by centralizing all study information, enhancing efficiency and precision, and more.

How FAIR Data Principles Power Clinical Analytics Success

Explore key challenges in accessing and preparing analytics-ready clinical data, how FAIR guiding principles can help maximize the value of clinical trial data, and the impact of innovative analytics.

Data Analytics For Better ClinRO Quality

Many trials fail not because of ineffective treatments, but due to challenges in detecting treatment signals. Explore how advanced data analytics can improve ClinRO quality.

TRIAL MONITORING

Using Critical To Quality (CtQ) Factors To Identify The Critical Data For RBQM

Based on ICH E8(R1) quality by design (QbD) principles, experts explain the use of critical to quality (CtQ) factors to identify critical data that focuses the end-to-end RBQM process on patient safety and trial results.

Controlled Substances In Clinical Trials

Handling controlled substances presents layers of complexity. Partnering with an experienced CDMO is essential for managing scheduled materials during clinical studies.

Power Remote Cardiac Monitoring In Your Clinical Trials

Explore cardiac monitoring solutions for sponsors that are at the forefront of transforming technology.

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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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