GUEST CONTRIBUTORS

  • Optimizing FDA Submissions For Companion Diagnostics: Alternative Evaluation Pathways To Streamline Approval
    Optimizing FDA Submissions For Companion Diagnostics: Alternative Evaluation Pathways To Streamline Approval

    In part one of this series, we examined the history of companion diagnostic approvals by FDA and identified trends to suggest better approaches to optimize the review process. Here, we will analyze new avenues sponsors may consider to further streamline the review of these important products through the assessment of various regulatory submission types and FDA guidance.

  • Optimizing FDA Submissions For Companion Diagnostics
    Optimizing FDA Submissions For Companion Diagnostics

    In this article — part one of a two-part series — we will examine the history of companion diagnostic approvals by FDA. Through this process, trends can be identified to suggest better approaches to optimize review times.

  • Genome Sequencing - The Key To The Cancer Moonshot?
    Genome Sequencing - The Key To The Cancer Moonshot?

    Though the announcement may seem recent, it was actually in October of last year when Vice President Biden boldly announced the “moonshot to cure cancer,” a personal passion fueled by his son’s death from the disease. Half a year later, this tall-order still has the industry – and world’s – attention, remaining the cause of consistent speculation and debate.

  • 4 Effective Ways To Accelerate Your Clinical Trial

    Your clinical trial is finally underway, and most of the sites you engaged are ready to start enrolling patients. Yet for some reason, your study is already behind schedule. What went wrong? What can you do to get it back on track? Is a protocol amendment required?

  • ASCO To Take A Closer Look At Patient-Reported Outcomes In Clinical Trials And Cancer Care

    While the annual meetings of the American Society of Clinical Oncology (ASCO) can almost always be counted on to generate news about scientific breakthroughs in understanding and treating cancer, the theme for this year’s conference goes beyond that conventional approach. ASCO 2016 Annual Meeting will prominently feature discussions about how clinicians can best integrate recent advances, and particularly how to best assess the impact on real-world patients.

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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.

Visitors are enriched with valuable information on CRO, Pre-Clinical Contract Research Organization, Bio-Analytical Contract Research Organization, Clinical Contract Research Organization, Pharmacovigilance, Clinical Data Management, Electronic Patient Reported Outcomes (ePRO), Point-of-Care Testing (POCT), Patient Recruitment, Electronic Data Capture (EDC), Clinical Trials Management Systems (CTMS) and more that can improve your business and make it more profitable.

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INDUSTRY INSIGHTS

  • Top 3 Benefits Of Electronic Data Capture Adoption - Infographic
    Top 3 Benefits Of Electronic Data Capture Adoption - Infographic

    Electronic Data Capture (EDC), which collects clinical trial data electronically rather than on paper, is becoming an increasingly popular solution for streamlining data processing.

  • 3 Ways To Maximize Your Summer Slow-down To Jumpstart Fall Recruitment
    3 Ways To Maximize Your Summer Slow-down To Jumpstart Fall Recruitment

    It’s important to take advantage of a slow-down in activities to plan for the future. Use any downtime during summer to plan ahead for your patient enrollment push in September and into the following year.

  • 5 Clinical Supply Tips For Handling Investigator Initiated Trials
    5 Clinical Supply Tips For Handling Investigator Initiated Trials

    Clinical supply teams have been managing a surge in packaging, labeling, and distribution projects due to a rapidly increasing number of investigator initiated clinical trials. Theses are studies in which the primary investigator also serves as the study sponsor with investigational drugs or devices typically donated by a manufacturer.

  • How Are Clinical Trial Scandals Impacting FDA Regulations?
    How Are Clinical Trial Scandals Impacting FDA Regulations?

    Mortalities are rare during a clinical trial, especially during the initial stages. But in January 2016, six men in France who had enrolled in a phase I trial of a pain relief drug suffered brain damage. One man died. FDA regulators began working with their French counterparts to understand what happened to the six men who signed up to test the drug, which goes by the name BIA 10-2474.

  • Comparator Sourcing In Emerging Markets: Look Before You Leap
    Comparator Sourcing In Emerging Markets: Look Before You Leap

    The broad appeal of emerging markets for comparator sourcing is offset by the innumerable challenges that can arise in such regions. By addressing concerns prior to the jump into uncharted territory, risks can be minimised and common pitfalls avoided.

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LIFE SCIENCE INDUSTRY EVENTS

Medical Applications in 3-D Printing: Clinical Benefits, Regulatory Issues, and Manufacturing Challenges June 30, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
How to Write SOPs That are GCP Compliant and Implementable July 12, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Single-Use Disposable Process Technologies - Best Practices And Advantages July 13, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Preparing eCTD Submissions: A Step-By-Step Guide July 14, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
The Investigator Meeting – Regulatory Requirements and Obligations that Ensure Success July 19, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
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