White Papers

  1. 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.

  2. 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 Using examples of both published and unpublished clinical studies, we highlight the importance of proper design and planning and appropriate ethical due diligence in the successful conduct of an adaptive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.

  3. 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.

  4. Cell Therapy Logistics
    2/11/2019

    Having a sound logistics strategy to ensure that a living drug is delivered to the right patient at the right time, location, and temperature is essential to patient safety and product effectiveness.

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

    Erythrocytes have significant value in specific types of research. If your objective is biobanking these cells in an intact state then it is equally important that hemolysis and the need for a re-draw is avoided. This paper explains how hemolysis can be prevented during specimen collection and handling.

  6. Standardizing 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.

  7. 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.

  8. Off-Site Storage Of Biological Specimens And Biologics 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 infrastructure in place, beginning with a realistic threat assessment.

  9. Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics
    2/11/2019

    Organizations recognize the growing need for control of the entire cold chain as the changing global scenario requires highly efficient processes and flexibility.

  10. 505 (b)(2) vs. ANDA: How Complex Drugs Fit In
    2/7/2019

    Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.