GUEST CONTRIBUTORS

  • A Cost-Utility Analysis Of Vertex’s CF Drugs — What It Teaches Us About Trial Design
    A Cost-Utility Analysis Of Vertex’s CF Drugs — What It Teaches Us About Trial Design

    Commercial success in the pharmaceutical industry requires that clinical programs, in addition to demonstrating clinical effectiveness, also provide data supporting a drug’s value. The Institute for Clinical and Economic Research (ICER), a U.S.-based cost-effectiveness watchdog, recently released an analysis suggesting that Vertex Pharmaceuticals’ cystic fibrosis (CF) franchise — Kalydeco, Orkambi, and the recently launched Symdeko — while offering meaningful clinical efficacy, would require discounts of approximately 70 percent1 to be cost-effective.

  • Adverse Event Reporting On Social Media — What You Need To Know
    Adverse Event Reporting On Social Media — What You Need To Know

    Adverse events (a suspected reaction to the API or to the API in combination with prescribed medicines or environmental factors) are, naturally, a challenging situation for patients in a clinical trial and may, in rare cases, become severe or even fatal. For sponsors, contract research organizations (CROs), and logistics partners, early notification and accurate information is vital to understanding and responding to a suspected adverse event. What happens if the patient goes off protocol and turns to social media?

  • Self-Deception — The 3 Most-Repeated Lies Of Trial Master File QC
    Self-Deception — The 3 Most-Repeated Lies Of Trial Master File QC

    Achieving inspection readiness means that during all stages of a clinical trial, a regulatory inspector would be able to walk into the building and reconstruct the trial using only the documents and metadata present in the trial master file (TMF). Although the concept of an inspection-ready TMF may be simply described, inspection readiness is not easily achieved. The failure to achieve an inspection-ready TMF continues to be an area of growing risk for the clinical research industry.

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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

Using Social Media for Patient Recruitment in Clinical Trials July 26 - 26, 2018
1)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Writing Effective 483 and Warning Letter Responses August 2 - 2, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
The Medical Device Reporting (MDR) Guidance – An Easily Digestible Compliance Breakdown August 7 - 7, 2018
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Price:  $299 - Includes Bonus Handouts!
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Writing Effective 483 and Warning Letter Responses August 2 - 2, 2018
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Communicating Beyond the Label: FDA’s Finalized Guidances & Updates August 8 - 8, 2018
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How to Write SOPs That are GCP Compliant and Implementable August 16 - 16, 2018
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