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. 

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CLINICAL TRIAL WHITE PAPERS

  • Making The Most Of Clinical Trial Data
    Making The Most Of Clinical Trial Data

    To control costs, improve efficiency, and successfully bring more drugs to market—life-changing, life-saving drugs—pharma and biopharma companies need to follow the lead of the financial industry and forward-thinking health systems. Here, we discuss how a data-driven approach to clinical trials—from patient recruitment to post-regulatory approval—can put an end to missed deadlines, failed studies, and wasted time and money.

  • 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.

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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.

Please take a moment to join our community and discover the benefits of your free membership.

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INDUSTRY INSIGHTS

  • What To Look for When Selecting A Risk-Based Monitoring Partner
    What To Look for When Selecting A Risk-Based Monitoring Partner

    There are no concrete instructions when it comes to RBM, and planning a successful RBM design can be challenging. Even so, we believe investing in an experienced partner to help you with RBM design is worthwhile. RBM can be an indispensable tool for your trial’s success. Following is an out of outline a criteria that could be helpful in finding the right RBM specialist.

  • Can Big Data Rescue Clinical Trials
    Can Big Data Rescue Clinical Trials

    Big data and data mining are being leveraged to improve drug development, with huge potential implications in identifying and correcting issues that arise during clinical trials. This article is a quick overview of what big data is and how we look at and define program failures and faltering trials.

  • 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.

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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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