Expert Insights On Data Management & Analysis

  1. New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies 5/16/2024

    The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.

  2. What Can Digital Patient Twins Do For Clinical Research? 4/29/2024

    Digital patient twins have the potential to vastly improve our current healthcare systems by offering personalized therapeutics, enhanced health monitoring, and streamlined pharmaceutical manufacturing, including clinical trials.

  3. Validating A Better ALS Biomarker With Coya's Fred Grossman 4/24/2024

    Coya Therapeutics President and CMO Fred Grossman, DO, FAPA discusses a potential new biomarker for ALS — 4-HNE, an oxidative stress biomarker — and how it could be more effective than the current standard, NfL.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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.

  9. 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.

  10. 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.