GUEST CONTRIBUTORS

  • How Many Team Members Does It Take To Determine The Study Status?
    How Many Team Members Does It Take To Determine The Study Status?

    Sitting on one of those long, painful, study status update calls recently, I was reminded of the famous light bulb joke. You know the one: “How many engineers (lawyers, politicians, etc.) does it take to change a light bulb?”  I was both flabbergasted and frustrated that, after 45 minutes, the project manager was still wading through status updates from a myriad of CRO and vendor partners and CRAs — just to figure out where the study was from a site activation and enrollment standpoint.  

  • The Evolution Of Medical Imaging In Clinical Research
    The Evolution Of Medical Imaging In Clinical Research

    Medical imaging plays an instrumental role in the clinical development of new life science products. Although the medical imaging industry is in a constant state of flux — due to increased investment in medical imaging companies, as well as mergers and acquisitions — adoption of novel imaging technologies to support clinical trials for the pharma, biotech, and medical device industries continues to increase. In fact, “centralized” imaging data is now used as a primary endpoint in many clinical research studies. This article will explore the factors driving imaging implementation in clinical trials, the current hurdles to increased adoption, and some of the technologies available to help overcome those challenges.

  • Will Special Interests Derail The Future Of Personalized Medicine?
    Will Special Interests Derail The Future Of Personalized Medicine?

    Treatment of cancer using chemotherapy (chemo) drugs began soon after WWII, when a compound called nitrogen mustard was studied and found to work against cancer in the lymph nodes. In the years that followed, many chemo drugs have been developed that work by non-selectively inhibiting rapidly dividing cells. In other words, chemo drugs kill cancer cells, but they also kill healthy cells in patients. The effectiveness of chemo treatments has therefore traditionally been determined by how well the toxicity of chemo drugs can be tolerated and/or managed in a patient.

  • Improving Patient Retention & Engagement Through Health Programs

    Patient recruitment is often highlighted as the key factor in ensuring clinical study success. Ensuring on-time enrolments of patients, investigators, etc. is a constant concern throughout the clinical trial phases. However, patient retention through engagement is also a key factor — and one that is often overlooked. Patient dropout rates for pharmaceutical clinical trials are estimated to range between 15 to 40 percent of enrolled participants, depending on the trial phase.

  • Trump And The FDA: What to Expect (And What’s At Stake)

    Donald Trump’s advance team will soon be headed to FDA’s White Oak campus to observe and learn about the agency, to help facilitate the transition from the Obama administration to the Trump administration. In this article, I describe what I expect the nascent 2017 agenda will be as Trump’s team walks in the door, and I offer a few thoughts as to why the Trump team would do well to consider the unique nature of FDA as transition planning takes shape.

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Welcome to Clinical Leader, the premier online community that helps streamline clinical research by connecting trial sponsors and cutting edge service providers. Clinical Leader is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.

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INDUSTRY INSIGHTS

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LIFE SCIENCE INDUSTRY EVENTS

Authoring and Implementing Standard Operating Procedures (SOPs): Best Practices for Success February 21, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Clinical Trial Budgeting & Forecasting February 22 - 23, 2017
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Communication With FDA: What Do We Say And How Do We Say It? February 23, 2017
1pm-2:30pm EST, Online Training
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Laboratory Data Integrity: Current Expectations for OOS Result Investigations February 24, 2017
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The New Medical Device Reporting (MDR) Guidance – An Easily Digestible Compliance Breakdown February 27, 2017
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Communication With FDA: What Do We Say And How Do We Say It? February 23, 2017
1pm-2:30pm EST, Online Training
Laboratory Data Integrity: Current Expectations for OOS Result Investigations February 24, 2017
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CRO Oversight: Risk Assessment & Action Planning March 1, 2017
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