Insights On Trial Design

  1. Flow Cytometry Capabilities
    10/31/2018

    How enhanced state-of-the-art flow cytometry capabilities empower flexible approaches to global clinical trials across multiple therapeutic areas.

  2. Research For Today: Pragmatic Clinical Trials
    10/26/2018

    Pragmatic clinical trials offer a means to close potential gaps between a research study and clinical practice.

  3. 3 Best Practices For Compliance-Focused Learning Management
    10/23/2018

    How a right-fit system will help you embed best practices into your operations simply through the implementation and administration of the technology.

  4. The Convergence Of GDPR, The HIPAA Security Rule, And Part 11 On US Clinical Research
    10/10/2018

    As electronic research systems are increasingly relied upon to store participant data, report results, and confirm informed consent, regulatory bodies around the world are re-examining old regulations and developing new ones. Discover what it means for US research.

  5. Considerations For Using eTools In Research: Part 11 And System Validation
    10/10/2018

    Automation is a foregone conclusion, and research sites need to prepare themselves for the electronic future that lies ahead.

  6. Trial Results Summaries: Improving Patient Communications
    10/4/2018

    This paper discusses the challenges inherent in the current practices of providing trial results summaries to trial participants. It presents an alternative approach to distributing trial results summaries that takes advantage of commonly used technologies to more quickly, efficiently and reliably provide trial results summaries to trial participants. The benefits of this approach to clinical trial sponsors, patients, and their relationship with each other are also discussed.

  7. 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.

  8. 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.

  9. 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).

  10. 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.