GUEST CONTRIBUTORS

  • 4 Pitfalls To Avoid When Developing GCP SOPs
    4 Pitfalls To Avoid When Developing GCP SOPs

    This article is the second in a series examining strategies that allow quality groups to collaborate with GCP and GMP groups to improve ICH E6(R2) compliance, increase clinical study robustness, and enhance data integrity.

  • CRO Outsourcing — How To Optimize Your Selection Process
    CRO Outsourcing — How To Optimize Your Selection Process

    This is part 2 of a three-part article series on how best to procure, manage, and implement best practices in the complicated CRO market.

  • How To Tell If A CRA Candidate Is Lying
    How To Tell If A CRA Candidate Is Lying

    I was recently invited to speak on the subject of fraudulent candidates and fake clinical research associates (CRAs) at the Global 2018 ACRP Conference and was astonished at how many hiring managers were not aware applicant fraudulence exists. 

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CLINICAL TRIAL WHITE PAPERS

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ABOUT CLINICAL LEADER

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

  •   Triple-A RWE: Adequate Data, Appropriate Study Designs, And Actionable Evidence
    Triple-A RWE: Adequate Data, Appropriate Study Designs, And Actionable Evidence

    Representatives from research institutions, industry, and FDA discuss guiding principles regarding the selection of adequate RWD sources and appropriate study designs within the regulatory context.

  • Analyzing Innovations Progress In The Gottlieb Era
    Analyzing Innovations Progress In The Gottlieb Era

    Experts from the realms of regulatory affairs, venture capital and industry discussed the FDA Commissioner’s impact on, and new opportunities for, industry-agency collaboration in the development and regulation of innovative new therapies.

  • The Fight Against Antimicrobial Resistance: International Regulatory Convergence
    The Fight Against Antimicrobial Resistance: International Regulatory Convergence

    The “International Regulatory Convergence” DIAmond session brought together representatives from the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and Health Canada to discuss how regulatory agencies seek to set strategic goals and priorities for various collaborative regulatory initiatives addressing AMR.

  • Mobile eTMF: The Pain Of Yesterday.The Relief Of Today.
    Mobile eTMF: The Pain Of Yesterday.The Relief Of Today.

    Since the launch of myTI—TransPerfect’s mobile experience for the Trial Interactive eTMF—I have heard rave reviews from clinical operations leaders and CRAs. The advantages of mobile technology for clinical operations are generating a lot of excitement, and rightfully so. In my collaboration with study teams during the development, release, and ongoing evolution of myTI, we encountered many thematic pain points that were ripe for a mobile solution.

  • Pediatric Clinical Trials: The Need for Regulation
    Pediatric Clinical Trials: The Need for Regulation

    An overview of the progress that has been made in pediatric drug development.

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LIFE SCIENCE INDUSTRY EVENTS

4th Annual 340B Manufacturer Summit August 21 - 22, 2018
Arlington, VA)
Bio/Pharma Forum on the State of Medicare Reform August 21, 2018
Arlington, VA)
Understanding & Implementing The Revised NIH & FDA Clinical Trial Protocol Template August 21 - 21, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response August 22 - 22, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Measuring Medical Affairs Success – Identifying the Key Performance Indicators (KPIs) for Successful Teams August 24 - 24, 2018
1:00 PM - 2:00 PM EDT)
Duration:  60-Minutes
Price:  $199 - Includes Bonus Handouts!
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