Regulatory Insights

  1. Tracking And Managing Global Disclosure Performance
    10/4/2018

    The following paper discusses the challenges of tracking global disclosure performance and how clinical trial sponsors can use Atlas Global Compliance to manage track and reduce the risks of non‐compliance.

  2. One Source Drives One Process For Clinical Trial Transparency
    10/4/2018

    Sponsor was challenged with lengthy, resource-intensive processes to support compliance in clinical trial registration and results reporting.

  3. Improving Compliance While Reducing Resources
    10/4/2018

    A global sponsor organization that develops pharmaceuticals, biologics, medical devices and over-the-counter products, sought a better approach to clinical trial registration and results disclosure requirements in the US. Using templates and spreadsheets, the sponsor team was spending approximately 20 hours to draft, finalize, approve and release one initial study registration to the US clinical trial registry (www.clinicaltrials.gov).

  4. Clinical Trial Transparency: The Technology Imperative
    10/4/2018

    This paper looks at clinical trial transparency and the driving forces behind it to better understand the role of technology in the execution of a solid clinical trial transparency policy.

  5. Syncing Transparency Processes To Improve Clinical Trial Compliance
    10/3/2018

    The Sponsor’s current system required redundant data entry, consisted of disjointed tools, and was a drain on valuable resources.

  6. 2 Steps For Correcting Non-Compliance With EU Disclosure Regulations
    10/3/2018

    To address non-compliance and improve the ratio of completed trials with results, we recommend the following two-step process to take control of your compliance.

  7. FDA Issues Draft Guidance On Blood Pressure (BP) Response In Clinical Trials
    9/4/2018

    Familiarize yourself with the new FDA draft guidance on blood pressure response which carries important implications for drug developers.

  8. A Survival Guide To Temperature Data In Life Sciences
    8/22/2018

    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.

  9. Changes to WHODrug Are Coming – Will You Be Ready?
    8/18/2018

    Why you should prepare now even with nearly a year remaining.

  10. 4 Tips For FDA Submission
    7/16/2018

    What can you do during your study to maximize your chances of success when it comes time to submit?