INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

  • A Survival Guide To Temperature Data In Life Sciences

    Regulations continue to evolve globally within the distribution arena of the Life Sciences industry. There is an increased focus on companies being able to prove the quality and integrity of their drug product throughout the entire clinical supply chain.

  • Vetting Your Vendor: A Reputation For Success

    When researching vendors, particularly in the tech space (and especially in clinical trial disclosure), you should look at more than just the price tag. Do your due diligence. How long has the vendor been in business? What does its client roster look like? What kind of reputation does it have in the industry?

  • Risk Evaluation And Mitigation Strategy (REMS) Overview

    UBC’s Natalie O’Donnell, Executive Director, SERRM, provides a Risk Evaluation and Mitigation Strategy (REMS) overview. Learn more about the importance in partnering with an experienced REMS team for your next study.

  • What Level Of Review Does Your Study Need?

    The level of IRB review required for research involving human subjects depends on the study’s specific design and the risks involved. Some research must be reviewed by the fully convened IRB, while others may be reviewed by a designated IRB member. Some projects may not even require IRB review. By applying the same four-step evaluation process used by IRB members, research professionals can better plan for a study’s necessary level of review and save time in study startup.

CLINICAL TRIAL REGULATORY SOLUTIONS

  • Electronic Trial Master Files

    As life sciences companies move to semi-virtual environments keeping only the most vital functions in house, more and more Trial Master Files are being converted to an eTMF format.

  • Central Laboratory Solutions

    Remember the time when laboratory kits were ordered and reordered by sites faxing in pieces of paper, and laboratory reports were faxed and express mailed to investigative sites around the world? Sadly that time is still here for many central laboratory providers.

  • TrialScope Transparency Management

    CLINICAL TRANSPARENCY
    Clinical trial sponsors are required by law to disclose information on their clinical trials in multiple places. These regulatory requirements continue to change as new mandated registries emerge and the scope of disclosure expands. This dynamic scenario creates a challenge for sponsors who must track and manage disclosure content that is being prepared for different registries, with different requirements.

  • DIA 2019 Annual Meeting Schedule At A Glance

    Download the at a Glance Schedule for DIA 2019 Global Annual Meeting - San Diego - June 23-27.

  • Regulatory Affairs

    As the clinical development of new medical products becomes more complex, so has the route to regulatory compliance that ensures patient safety and regulatory compliance.