White Papers

  1. Addressing Suggestibility As A Psychological Phenomenon In Clinical Trials
    2/22/2019

    How can researchers identify participants’ overall level of suggestibility and then focus on the minimization of this characteristic to solve the issue of suggestibility in clinical trial?

  2. Genetic Counselors - Helping Researchers Brace For The Silver Tsunami Of CNS Disorders
    2/22/2019

    Genetic testing is making it easier to identify patients for clinical trials. However, genetic testing in the context of clinical trials raises raise important ethical issues, including ones related to informed consent and disclosure of results. Genetic counselors can play a crucial role in helping sponsors address these operational and ethical issues, making trials more efficient, more patient-centered and, ultimately, more successful.

  3. Invert To Convert: Rethinking Patient Recruitment And Enrollment Strategies
    2/22/2019

    Overall, the landscape of patient recruitment and enrollment have become highly specialized and data-driven. They demand a specialized, data-driven approach that nurtures potential participants and delivers bottom-line results, quickly and within budget. Read how an Enrollment Assistant can reduce the site’s workload, accelerate enrollment and make the entire recruitment process more efficient.

  4. Ethical Considerations In Adaptive Design Clinical Trials
    2/20/2019

    While adaptive design is associated with many potential benefits, it may also present challenges to observing the basic ethical principles of research in human subjects. In this white paper, we review the features of particular clinical trial design adaptations and discuss the ethical obstacles they can present and those they can potentially resolve. Using examples of both published and unpublished clinical studies, we highlight the importance of proper design and planning and appropriate ethical due diligence in the successful conduct of an adaptive design clinical trial.

  5. A Next Generation Sequencing Approach To Influenza Vaccine Development
    2/19/2019

    NGS sequencing presents new possibilities for influenza vaccine development. This white paper covers the challenges of developing influenza vaccines and new approaches that may eventually lead to a more universal solution.

  6. Cell Therapy Logisitics
    2/11/2019

    Having a sound logistics strategy is critical to ensuring this living drug is delivered to the right patient at the right time, location, and temperature is essential to patient safety and product effectiveness.This paper will walk through key considerations for developing a successful logistics strategy for the management of cell-based material.

  7. Avoiding Hemolysis Blood Sample Collection Processing
    2/11/2019

    Hemolysis is a primary driver of the need for re-draw, resulting in wasted time and resources. This paper explains how can hemolysis be prevented during specimen collection as well as hemolysis and specimen handling.

  8. Standarizing Biosample Management - Why Use Collection Kits?
    2/11/2019

    Whether you are conducting a phase 3 clinical trial of a new therapy or looking for biomarkers, you will need to collect samples, and that leads to a number of questions. Following are some basics to help with planning sample collection and to help make the process as cost-effective as possible.

  9. The Golden Retriever Lifetime Study: 5 Years Of Progress In Veterinary Health And Biobanking
    2/11/2019

    This whitepaper is an overview of a prospective cohort study of approximately 3,000 Golden Retrievers under the age of 2 years at enrollment and how the extensive data and biological sample repositories will be used for future analyses of major diseases, disorders or conditions in Golden Retrievers.

  10. Defense In Depth: Off-Site Storage Of Biological Specimens And Biopharmaceuticals For Risk Mitigation
    2/11/2019

    Choosing an offsite storage facility means asking the right questions, to determine if the storage provider has the appropriate risk mitigation infra-structure in place, beginning with a realistic threat assessment for the location.