Insights On Clinical Technologies

  1. EU's New Clinical Trial Regulation: What Does It Hold For Sponsors And Sites? 7/23/2024

    The Clinical Trials Information System (CTIS) is a centralized platform for Clinical Trial Application (CTA) and marketing authorization submissions, and supervision of clinical trials across the European Union/European Economic Area (EU/EEA). The regulation, which came into effect on January 31, 2022, aims to simplify and streamline routine clinical processes.

  2. Optimizing Clinical Data: Reducing Redundancy For Efficiency 6/6/2025

    Enabling sites to focus solely on critical data facilitates faster data entry, reduces queries, and fosters better relationships between sponsors, CROs, and sites.

  3. How Healthy Is Your TMF? A Check-In Before An Inspection 3/18/2025

    Explore how proper oversight of the Trial Master File (TMF) prevents inspection findings. Regular reviews, heatmaps, and risk-based assessments help ensure TMF health, and readiness for regulatory inspections.

  4. Electronic Hauser Diary For Parkinson's Clinical Trials 12/9/2024

    In honor of World Movement Disorders Day, we highlight advances in Parkinson’s disease care. At the 2024 MDS Congress, Signant presented research on electronic diaries for tracking PD patients' functional status.

  5. Financial Scenario Planning — Budget With Confidence 4/12/2024

    Find out how financial scenario planning can revolutionize clinical trial budgeting with dynamic models, real-time data, and instant scenario visualization—all in one intuitive platform.

  6. 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.

  7. Precision Project Management In Action 6/12/2025

    Discover how a tailored, risk-based project management approach was used to overcome the challenges of a complex Phase I/IIa FIH multi-country study of an advanced therapy medicinal product (ATMP).

  8. The Catch-22 Of eConsent: A Missed Opportunity For Improved Trials 3/21/2025

    Drawing on evidence from scientific literature, we examine the pitfalls that have hindered its success and propose actionable solutions to unlock its true value in clinical research.

  9. Let's Get SMART On Adverse Events 1/17/2024

    One of the biggest risks for medical products and companies is the failure to report adverse events. But what leads to underreporting? Here are five core reasons behind most adverse event underreporting.

  10. Introducing TrialKit AI For Advanced Analytics And Reporting 10/4/2024

    Check out this workshop introduction to TrialKit AI’s dynamic analytics and reporting capabilities.