Featured Articles

  1. Top Biotech Achieves Recruitment And Improves Compliance Across 30 Sites 5/14/2024

    Uncover how a biotechnology company experienced recruitment and compliance success after utilizing Longboat to provide training for every staff member at every trial site.

  2. Reporting To The IRB: Investigator Noncompliance 4/19/2024

    Reporting noncompliance concerns is crucial to protect research participants, allowing researchers can ensure ethical research conduct and protect the rights and welfare of participants.

  3. The Value Of Continuity: Program-Level DSMBs 4/19/2024

    Discover the strategic benefits of deploying consistent Data Safety Monitoring Boards (DSMBs) members across therapeutic programs.

  4. Clinical Trial Startup: Insights From The Industry 11/17/2023

    Uncover key survey findings gleaned from the perspectives of over 500 clinical researchers regarding technological trends and recommendations for enhancing the overall site experience.

  5. Leading eSource Software Company Receives Part 11/Annex 11 Verification 9/26/2023

    Uncover how an independent confirmation of compliance opened up new opportunities and is instilling confidence in customers who are integrating the eSource system into their software validation strategy.

  6. Developing And Implementing A Successful eConsent Process 2/16/2023

    To ensure a seamless implementation process, organizations should consider taking the steps outlined in this article before the first patient uses a new electronic consent platform.

  7. Regulatory And Ethical Considerations For eConsent In Research 12/14/2022

    Although it’s becoming more widespread, explore why there are currently no definitions for eConsent in the Human Subjects Protection– it’s a concept only described in guidance.

  8. How Paper And Electronic Source Data Meet ALCOA-C Principles 10/24/2022

    According to the Food and Drug Administration (FDA), data should meet certain fundamental elements of quality. If these best practices for source documentation aren’t followed, there is no valid evidence the test article is safe and effective. 

  9. Unpacking IRB Innovations For Decentralized Clinical Trials 10/24/2022

    This blog highlights how IRBs can simplify review of electronic patient reported outcome (ePRO) and electronic clinical outcome assessment (eCOA) materials to streamline study startup without impacting the review quality.

  10. Beginner's Guide To 21 CFR Part 11 Compliance 9/21/2022

    Computer systems used for clinical trials fall under Food and Drug Administration (FDA) 21 CFR Part 11. While Part 11 is widely known, this blog explains how it fits in with your research software.