GUEST CONTRIBUTORS

  • 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.

  • Why You Should Care About Real-World Evidence (A Lot)
    Why You Should Care About Real-World Evidence (A Lot)

    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.”

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.

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

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INDUSTRY INSIGHTS

  • Unlock Historical Data To Enrich RBM Insights
    Unlock Historical Data To Enrich RBM Insights

    The data landscape for clinical operations is complex and comprised of many disparate sources, so a data agnostic solution is essential for full access and visibility into the data. Without an intuitive visual analytics tool, it becomes impossible to navigate data hierarchies and gain meaningful insights into the data.

  • Clinical Trial Development Medical Monitors Fear This The Most
    Clinical Trial Development Medical Monitors Fear This The Most

    Insights from medical monitors about the obstacles they face and their impact on the overall study conduct, operational efficiency, and most importantly, subject safety.

  • 10 Things To Remember About The QP Role And Process
    10 Things To Remember About The QP Role And Process

    The QP process is a necessary process that every sponsor company wishing to undertake trials in, or move product through the European Union must undergo. When faced with this process, many companies are unsure as to what to expect.

  • Key Factors To Evaluate When Considering BYOD Clinical Trials
    Key Factors To Evaluate When Considering BYOD Clinical Trials

    When making the switch from paper-based to electronic capture of Clinical Outcome Assessments (COA) data, there are a number of options that study teams must consider in terms of how the data is collected.

  • What’s Your Patient Centricity IQ?
    What’s Your Patient Centricity IQ?

    See how your colleagues in the drug development industry could surmise our participants’ aggregate answers from a survey of aimed at gaining an understanding of patient mindset and design more effective recruitment strategies.

More Industry Insights

LIFE SCIENCE INDUSTRY EVENTS

Improving Product Quality During Technical Transfer – Minimizing Risk, Maximizing Results September 20, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
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!
More Industry Events