Newsletter | April 5, 2024

04.05.24 -- 3 Reasons Why Sponsors Must Review Monitoring Reports

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EDC has become a premier clinical technology in improving data accuracy and reducing site burden through time and resource conservation. But which EDC do you choose? In this Clinical Leader Solutions Expo: EDC Showcase segment, Brian Dufresne, SVP of Business Development at CDS delves into who CDS is, what they do, how they're different, and how clinical research teams can quickly design, deploy, and manage studies without the need for programming via TrialKit. Watch here.

CLINICAL DATA MANAGEMENT & ANALYTICS

Dear Data Analysts, AI Is Not Replacing You

Deep beneath the ongoing narrative of AI’s potential use cases in clinical trials is the same fear that persists in other industries facing this technology revolution. Namely, will jobs be replaced by machines? So, I thought I’d ask an expert — a machine.

Bringing In Vitro Diagnostics To Market With Real-World Evidence

Explore the potential of real-world evidence in enhancing the regulatory decision-making process to facilitate the market entry of IVDs.

Accelerating AI Innovation In Pharma: Collaboration Vs. Competition

Learn how evolving with AI could potentially lead to more streamlined, efficient, and innovative drug development processes.

Data Hippies, Real-World Evidence, And Precision Medicine

Christopher P. Boone, Ph.D. discusses how democratized data and clinical innovation are moving us closer to the widespread adoption of precision medicine.

Using RWE To Get To Insights And Action — Faster

Delve into three examples that vividly showcase the formidable power of real-world evidence from the early stages of drug development through clinical trials and commercialization.

Defining ‘Evidence Generation' Within Modern Clinical Trials

Uncover how this distinctive approach centered on enabling clinical trial sponsors to gather data and generate evidence ensures the successful acquisition of diverse information.

Your Clinical Study Data Is In Good Hands

Every pharmaceutical company conducts a clinical trial before marketing a new medicine. Meet clinical trial deadlines and stay within budget by using this data management platform.

TRIAL MONITORING

3 Reasons Why Sponsors Must Review Monitoring Reports

Despite recent progress in executing and documenting oversight, sponsor oversight remains a challenge, especially with monitoring reports. Penelope Przekop detail three reasons why they must remain top of mind.

Be Inspection-Ready: Risk-Based TMF Quality Checks And Reviews

Roughly one-third of participants disclosed adherence to a system for evaluating TMF quality. Use this information and other insights to improve TMF quality and inspection readiness.

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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