GUEST CONTRIBUTORS

  • Patient-Focused Drug Development Under The 21st Century Cures Act
    Patient-Focused Drug Development Under The 21st Century Cures Act

    More than two years have passed since the 21st Century Cures Act was signed into law in December 2016. According to the FDA, the Cures Act is designed to help accelerate medical product development and bring new innovation and advances to patients who need them faster and more efficiently.

  • 4 Key Ingredients Of A Robust Risk Management Framework
    4 Key Ingredients Of A Robust Risk Management Framework

    It is certainly no surprise that risk management continues to hold the spotlight as a hot topic within the biotechnology/pharmaceutical industry. With the increased focus by regulatory authorities on an organization’s ability to identify, mitigate, and control risks, the industry remains in a state of growth, developing and evolving practices to ensure proper alignment with industry best practices and regulators’ expectations. Many organizations are finding it difficult to establish and embed risk management practices, as doing so requires a paradigm shift from a traditional risk-averse industry culture.

  • 4 Approaches To Data Access Strategy — And How To Apply Them Throughout Drug Development
    4 Approaches To Data Access Strategy — And How To Apply Them Throughout Drug Development

    Looking forward, it will be increasingly important for pharma companies to employ ingenious strategies to access data already existing in the healthcare environment, moving away from solely building and owning data sets. These new approaches will bring significant new opportunities and help companies to further differentiate their medicines from competitors and accelerate their products to market.

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CLINICAL TRIAL WHITE PAPERS

  • The Current Biomarker Landscape In Immuno-Oncology
    The Current Biomarker Landscape In Immuno-Oncology

    Dr. El Mustapha Bahassi, Associate Director of Clinical Laboratories at Medpace gives an overview of Central laboratories and the evolving world of immuno-oncology as well as current immuno-oncology biomarkers and detection methods.

  • Gene Therapies In Rare Disease: From R&D To Regulatory Approval
    Gene Therapies In Rare Disease: From R&D To Regulatory Approval

    Advancements in science and technology have helped researchers develop new treatments for some of the most common diseases known to man. For rare diseases, however, patients have limited treatment options. Advocacy groups and regulatory authorities continue to encourage rare disease research, and more and more scientists are stepping up to the task.

  • Bringing Real World Evidence Into Clinical Research
    Bringing Real World Evidence Into Clinical Research

    Life sciences companies are embracing the essential roles that real world data (RWD) and the generation of real world evidence (RWE) play in the development of new treatments for patients.This paper will explore three areas where RWD and RWE are being applied to improve the design and execution of clinical studies.

  • Confronting The Challenges Of Rare Disease
    Confronting The Challenges Of Rare Disease

    This paper is intended as a discussion of the commonly encountered hurdles in studying rare diseases and how a cohesive and holistic approach can mitigate issues and help bring new treatments to patients.

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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

  • Keeping It Cool: Protecting Cryopreserved Biological Samples From Degradation
    Keeping It Cool: Protecting Cryopreserved Biological Samples From Degradation

    Degraded samples are common and certainly problematic for investigators. Read more about common causes of degradation as well as agents and systems available to protect against freeze–thaw.

  • How A Problematic Database Project Inspired Me To Revamp eClinical Software
    How A Problematic Database Project Inspired Me To Revamp eClinical Software

    Mike Novotny, founder and CEO of Medrio, shares an experience from early in his career of building databases that showed him by having the right data at the right time, doctors can make decisions allowing patients to live their best lives possible.

  • Conducting The Advanced Therapy Supply Chain Orchestra
    Conducting The Advanced Therapy Supply Chain Orchestra

    Conducting the advanced therapy supply chain orchestra is more than waving a stick at people – it is an “end to end”, complicated, inter-related system that requires controlled, consistent management. Following are some things you need to think about to develop the capability to provide a harmonious supply chain management system.

  • EudraVigilance Survival Guide
    EudraVigilance Survival Guide

    What it is, why it is important, and what sponsors need to think about as it gets closer.

  • Importance Of Chain Of Custody Documentation For Biologics
    Importance Of Chain Of Custody Documentation For Biologics

    Preventing patients from receiving “counterfeit, diverted, sub-potent, substandard, adulterated, misbranded, or expired drugs” is a critical element of the mission of the US Food and Drug Administration (FDA). Chain of custody for genetic and cell therapies differs and is more complex than for traditional pharmaceuticals, and the requirements for documentation vary as well.

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LIFE SCIENCE INDUSTRY EVENTS

Writing Effective 483 and Warning Letter Responses May 23 - 23, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
8th Annual Avoca Global Summit June 5 - 6, 2019
Boston, MA
Applying Six-Sigma Tools and Concepts in Clinical Research – A Process Improvement Guide June 6 - 6, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Adverse Event Reporting: Avoiding Common Pitfalls June 11 - 11, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Laboratory Data Integrity: Current Expectations for OOS Result Investigations June 12 - 12, 2019
1:00 PM - 2:30 PM EDT
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
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