Clinical Guest Contributors

  1. Does Your Clinical Trial Marketing Answer Patient Questions?
    3/20/2018

    As clinical studies become more specialized and procedures become increasingly cumbersome, patient recruitment remains a challenge. Medical centers’ ability to fill enrollment continues to fall behind, and the focus has shifted to centralized advertising campaigns. But is a centralized advertising campaign a complete marketing strategy?

  2. A Practical Framework For Assessing Risk In Clinical Trials
    3/15/2018

    The purpose of a comprehensive assessment system is to support structured, systematic, objective, and rational decision making. This holds true even when assessing something as difficult to pin down as risk. 

  3. 5 Keys To Establishing Quality Partnerships Between Sponsors And CROs
    3/13/2018

    What is the cost of a failed partnership between a pharma company and its CROs?  Is it financial?  Research and development time? 

  4. Legal & Ethical Considerations For Informed Consent In Clinical Trials
    3/8/2018

    The purpose of this article is to provide some thoughts as to the role each of us can play in clarifying some issues related to informed consent. These perspectives are based on my experiences as a registered nurse in a career that spanned more than three decades in private hospital settings, a private surgical association, and a university health system.

  5. Edgy Observations On Clinical Site Documentation Management: Leading Or Bleeding?
    3/6/2018

    For an investigational trial, clinical site documentation encompasses many types of records. These cover every aspect of patient care, policy guidance, and study execution. Not only does the patient medical history and care need to be maintained, but documentation supporting the plan and evidence of execution of a clinical trial must also be managed. This extensive collection of information is always subject to regulatory inspection.

  6. 3 Keys To Successful Blockchain Adoption In Clinical Research
    3/1/2018

    Excitement around the potential for blockchain platforms continues to build. This parallels the surge in popularity of blockchain-based cryptocurrencies such as Bitcoin. Meanwhile, “critics argue it’s all hype — a technological hammer looking for a nail — and that the complexities of health information prevent practical use of blockchain technology.”

  7. Revitalizing Clinical Trial Information Exchange & Registries
    2/27/2018

    Patients, family members, and friends make up the largest user group of clinical trial registries such as ClinicalTrials.gov, according to the U.S. National Library of Medicine. Clinical trial registries serve many important purposes for patients, which is why having an online resource that is not only user-friendly, but also patient-centered, is imperative. Access to a wealth of information on clinical research has become increasingly important for many stakeholders, with patients at the forefront.

  8. Fear, Indecision, And The Memo To File
    2/22/2018

    How many times have you seen or heard this phrase? Perhaps it came in an email, echoed out of the conference room phone, or maybe you’ve even said it yourself?

  9. How To Negotiate Study Budgets Like A Pro
    2/20/2018

    Are you a clinical site that finds budget negotiations with a clinical research organization (CRO) or sponsor an uphill battle?

  10. Should You Bring Site Management And Monitor Oversight In-House?
    2/15/2018

    When a pharma or biotech sponsor company engages with a contract research organization (CRO) and other service providers, it develops a list that details which organization is responsible for each task to be conducted.  The degree to which a small to midsize sponsor has the expertise and the resources internally to manage a task, as well as budgetary constraints, will dictate which tasks it delegates and which it keeps in-house.