Clinical Operations Featured Articles

  1. Clinical News Roundup: Should Patient Advocacy/Private Funds Connection Raise Concerns?
    1/20/2017

    Clinical news roundup for the week of January 15, 2017 with information on the financial relationship between pharma and patient advocacy groups, the FDA take on diversity in trials, HHS rules on patient safety, venture funding of mobile apps, and more.

  2. Are You Correctly Conducting Your CRO Qualification, Oversight, And Audits?
    1/19/2017

    David Kim has spent most of his career working on clinical trials. His areas of expertise include implementing strategic alliances, leading and directing sourcing and vendor management teams, and partner negotiations. In this interview with Clinical Leader, Kim discusses the challenges of CRO qualification, oversight, and audits, and how to make sure you are not being overcharged for the work you outsource.

  3. Are Your Cell Therapy Samples Getting The Preservation They Deserve?
    1/17/2017

    With the number of biologics now in development and soon to be making their way into clinical trials, the preservation of cells, tissues, and organs are suddenly increasing in importance. Companies handling the manufacturing, storage, and transportation of these materials need to be focused on improving the yield and extending the shelf life of these time and temperature sensitive biologics.

  4. Which Clinical Conferences Are Worth Your Time?
    1/13/2017

    If you are like me, you get bombarded with clinical conference promotions on a daily basis. In an age where we are inundated with electronic interactions, connecting with individuals face-to-face has become a rarity. While conferences enable that interaction, job requirements limit your out-of-office opportunities. So how do you decide which clinical conferences are worthy of your time?

  5. Lexicon Uses Patient Input To Support Primary Endpoint
    1/4/2017

    When Lexicon Pharmaceuticals began planning for a clinical trial on neuroendocrine tumors, there were two things it hoped to accomplish. First, it wanted to incorporate patient voice into the trial design. Second, the company wanted to incorporate some type of mobile technology into the trial to help track feedback from patients.

  6. Is CRA Shortage To Blame For CRO Turnover?
    12/20/2016

    The results of a study on compensation released by HR+Survey Solutions (HR+SS) show that turnover in the U.S. for clinical monitoring jobs at CROs remained high in 2015. Clinical monitoring jobs, such as clinical research assistants (CRAs), involve individuals whose job function is monitoring the health of study participants in clinical trials.

  7. How Pfizer Uses Patient Video To Improve Sickle Cell Trials
    12/16/2016

    Sickle cell disease is a red blood cell disorder where patients have abnormal hemoglobin in those cells. In this interview Brenda Cooperstone, VP and chief development officer for the specialty care business unit at Pfizer, discusses the efforts made to understand sickle cell patients, their condition, and how the company should interact with them during visits to the emergency room.

  8. Clinical Leader Forum: A Conference Designed For You
    12/14/2016

    I attend a lot conferences and events each year focused on clinical trials. Almost all of the content revolves around high-minded topics like RBM, Big Data, and TransCelerate initiatives. While those topics are interesting for some, I speak to countless executives throughout the year who handle clinical ops for their companies. Their reality includes outsourcing trials and trying – to the best of short-staffed and underfunded situations – to manage this unwieldy process

  9. Clinical Leader Strengthens Editorial Advisory Board
    12/14/2016

    In 2016 Clinical Leader added eight distinguished members of the clinical trials community to our Editorial Advisory Board. These individuals help to guide our editorial focus and direction.

  10. IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For November 2016
    12/9/2016

    Below are my top three articles downloaded on Clinical Leader for the month of November 2016. In case you missed them, please take this opportunity to see what everyone else was learning about the growing clinical staff shortage, how Lilly is helping physicians become researchers, and how Duke and PatientsLikeMe are bringing a novel approach to ALS trials.