White Papers

  1. Unlocking The Potential Of Decentralized Clinical Trials 3/23/2023

    Explore the current DCT landscape and its evolution, as well as the key advantages of incorporating decentralized attributes and how barriers to their inclusion can be overcome.

  2. Leveraging The Bolar Exemption To Accelerate Market Access 3/17/2023

    Gain insight into the changing comparator sourcing landscape, focusing specifically on the instrumental role the Bolar exemption plays in the shift away from dependence on innovators for clinical supplies.

  3. Real-World Sleep Assessments Using Wearable Technologies 3/16/2023

    The first step to finding proper care for people living with sleep disorders is the accurate and reliable assessment of sleep patterns. Explore the use of wearable DHTs to objectively assess sleep from the comfort of participants' homes.

  4. Adaptive Designs Save Time And Money: Why Aren’t They Used More Often? 3/14/2023

    Get a brief introduction to adaptive designs, including their major benefits and challenges and best practices for operationalizing them. This foundation will help maximize the likelihood of success when implementing an adaptive trial design.

  5. FDA's Q&A On 21 CFR Part 11 For Clinical Investigations 3/14/2023

    Examine six of the more significant points from the draft guidance, specifically as they pertain to the electronic Trial Master File.

  6. Strategies To Achieve Labeling Harmonization Amid A Legal Entity Change 3/9/2023

    A strong labeling team is vital to ensure successful navigation of the legal entity change process, including developing a timeline, executing data transfers, and mitigating compliance risks.

  7. 7 Considerations For eCOA Technology Solutions 3/3/2023

    As with any technology used in clinical research, choosing the right vendor, solution, and deployment model is critical for success. Sponsors seeking the best eCOA for their team should consider these seven best practices from IQVIA eCOA expert J.C. Wilson.

  8. Revolutionizing Patient-Centric Supply Chains To Improve Vaccine Access 3/1/2023

    Transparent collaboration and innovation are essential to establishing an infrastructure that supports more agile business models and empowers widespread vaccine access.

  9. Optimizing Storage & Distribution In An Era Of Clinical Trial Transformation 3/1/2023

    Explore the rapidly evolving complexities of clinical storage and distribution and how customized and patient-centric solutions have never been more paramount to support the healthcare of tomorrow.

  10. The New Industry Migration Framework For FSP 2/28/2023

    Review why a functional service provider should be on the top of a sponsor’s list when it comes to choosing a specialized eClinical data management provider for its next study.