Central Laboratories Featured Articles

1. Shorter, Faster, Cheaper: Powerful New Data On Digital Endpoints 4/16/2024

   The idea of leveraging novel, sensor-based measures to gather data for clinical trials is not new, but relevant evidence of their usefulness is. Here, DiMe experts discuss the impact of digital endpoints on trial success.

2. FDA Warns Industry Of Fraudulent & Unreliable Lab Testing Data In Premarket Submissions 4/11/2024

   The FDA recently announced that they have seen an increase in the number of entities that contract out testing or services where the data provided by said firms was fabricated, duplicated, or just deemed “unreliable.” Here's what you can do.

3. ICH E6(R3) And Defining What Is Critical To TMF Quality 4/9/2024

   By applying Quality by Design to clinical trials, sponsor companies can rise to meet the elevated role and importance of the TMF in the face of ICH E6 (RF3).

4. 2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies 4/9/2024

   Clarkston Consulting conducted its third annual Chief Information Officer (CIO) Survey to understand IT budgets of life sciences companies, how AI priorities fit into those budgets, and more.

5. AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance 4/8/2024

   The World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.

6. Dear Data Analysts, AI Is Not Replacing You 4/2/2024

   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 lost and replaced by machines? So, I thought I’d ask an expert — a machine.

7. New FDA Draft Guidance: Data Monitoring Committees In Clinical Trials 4/1/2024

   In a new draft guidance, the FDA describes expectations of data monitoring committees in clinical trials. The public comment period ends April 15, 2024.

8. A Structured Approach To Regulatory Information Management Vendor Selection 3/13/2024

   Deploying a formal system for regulatory information management is a given now for all life sciences companies, irrespective of their size and focus. Regulators expect this, particularly as data rather than static documents evolves to become the default.

9. Best Practices For Complete Registration And Reporting Of Summary Results On ClinicalTrials.gov 3/5/2024

   The Clinical Trials Transformation Initiative (CTTI), alongside the FDA, investigated factors and barriers to registration and summary results information reporting. Here is what they found and what they suggest for ensuring complete reporting of trial results.

10. Leveraging AI For Data Analysis In Pharmacy-Based Trials 2/28/2024

    Leveraging AI for data analysis in pharmacy-based trials holds immense potential for revolutionizing drug development and healthcare delivery.