GUEST CONTRIBUTORS

  • Why Pharma Needs A New Approach To Patient Engagement In Drug Development
    Why Pharma Needs A New Approach To Patient Engagement In Drug Development

    Pharmaceutical companies face many challenges: developing life-changing products that meet the needs of patients, physicians, and payers; adhering to regulatory standards; and managing health technology and payer scrutiny, all while trying to satisfy investors. As drug prices seem to be continually rising, many health plans are shifting more of the cost-sharing burden to patients.  As a result, the patient is becoming more of a “consumer” in the traditional sense.

  • Real-World Evidence & The 21st Century Cures Act — What You Need To Know
    Real-World Evidence & The 21st Century Cures Act — What You Need To Know

    When the Clinical Leader team attended the 2017 DIA Annual Meeting in June, the topic we heard discussed more than any other was real-world evidence (RWE) — that is, information about a drug that is collected outside of clinical trials. RWE is not a new concept, but there are good reasons for all the current attention being paid to it in the pharma industry. For one, the 21st Century Cures Act, enacted into law in December 2016, seeks to speed the FDA drug and medical device approval processes by shifting some of the evidentiary requirements, in certain instances, from clinical trials to post-market  — in other words, to “the real world.”

  • 4 Ways To Listen Like A Linguist — And Improve Trial Inclusion
    4 Ways To Listen Like A Linguist — And Improve Trial Inclusion

    Practical discussions around inclusion often go something like this: A sponsor is interested in anticipating potential barriers to enrollment based on a newly drafted protocol.

More From Guest Contributors

CLINICAL TRIAL WHITE PAPERS

  • 10-Step Commercial Clinical Protocol Authoring Guide
    10-Step Commercial Clinical Protocol Authoring Guide

    Before the protocol authoring process even begins, a variety of activities and decisions are necessary to establish a strategy for success. The following steps provide concepts and considerations that are essential in formulating the details that will become the protocol synopsis and ultimately the clinical study protocol.

  • Regulated Content Management and the Digital Revolution In The LIfe Sciences Industry
    Regulated Content Management and the Digital Revolution In The LIfe Sciences Industry

    Globalization of clinical trials, tightening regulatory requirements, a more competitive and collaborative commercial environment, and an increasingly mobile workforce requires life-sciences companies to standardize and improve regulated content management processes to ensure information is shared with the right people at the right time.

  • Clinical Data Aggregation
    Clinical Data Aggregation

    Learn about the challenges for Sponsors and CROs when integrating a vast array of data sources, typical relational database structures and why they don’t work for clinical analytics,  as well as the ideal clinical data aggregation solutions for continuous, automatic data consolidation.

  • Speeding The Switch To Risk-Based Monitoring
    Speeding The Switch To Risk-Based Monitoring

    The adoption of RBM is increasing as companies provide greater management support, staff training and more sophisticated technology systems. Technology platforms that enable continuous monitoring with near real-time intuitive visualizations, analytic dashboards and applications will allow issues to be identified and addressed early, improving study safety and efficiency.

More Clinical Trial White Papers

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

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LIFE SCIENCE INDUSTRY EVENTS

15th Annual Global Forum September 25 - 29, 2017
Chicago, IL
The HireLifeScience.com Career Fair 2017 September 26, 2017
Edison, NJ
Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner September 28, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Organizational Strategies for Reducing Human Error in GMP Environments October 3, 2017
1:00 - 2:30 PM EDT, Online training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Understanding & Implementing The New NIH & FDA Draft Clinical Trial Protocol Template October 5, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
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