GUEST CONTRIBUTORS

  • Where Trial Sponsors & CROs Go Wrong With Patient Engagement (And How To Get It Right)
    Where Trial Sponsors & CROs Go Wrong With Patient Engagement (And How To Get It Right)

    As the care partner of a two-time cancer survivor who has benefited from being in more than one clinical trial, I am passionate about banging a loud and insistent drum that more patients need to have the opportunity to get "tomorrow's medicine today." After all, isn't that what clinical trials are all about? My life partner participated in a Phase II clinical trial for chronic lymphocytic leukemia (CLL) 17 years ago — and has been in remission ever since. The combination therapy he received in that trial is now one of the standard treatments for CLL. We are both grateful. So, why are only a tiny percentage of all cancer patients participating in clinical trials?

  • ICH GCP E6 (R2) – It’s All About Effective Oversight … And Pizza!
    ICH GCP E6 (R2) – It’s All About Effective Oversight … And Pizza!

    To some extent, the Integrated Addendum to ICH E6(R1): Guideline For Good Clinical Practice E6(R2)1, released Nov. 9, 2016 (and affectionately referred to as ICH E6 (R2)) has come and gone without much fanfare.

  • 5 Ways To Engage Clinical Trial Sites With Technology
    5 Ways To Engage Clinical Trial Sites With Technology

    Clinical research has a reputation for being notoriously slow to adopt new technologies. This should come as no surprise to those in the industry, since we operate in a highly regulated environment.

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CLINICAL TRIAL WHITE PAPERS

  • How Agile RTSM Software Development Accelerates The Clinical Trial Timeline
    How Agile RTSM Software Development Accelerates The Clinical Trial Timeline

    RTSM software developed with an agile methodology and built on a modern technology stack dramatically accelerates the study start-up process and mid-stream adjustments. Customers are able to see and interact with the system before approving specifications and changes can be made quickly, without impacting study progress. The use of agile software in clinical trials enables  customers to streamline internal processes and spend time on other high-value activities critical to the success of their studies.

  • Spotlight On Quality In Clinical Study Startup (SSU)
    Spotlight On Quality In Clinical Study Startup (SSU)

    There is a dazzling array of quality initiatives within the clinical trials sector all looking to move the needle from paper-based methods or single point solutions to a more integrated, non-siloed approach to study conduct. These efforts, may be rooted, at least somewhat, in work started nearly 20 years when the Institute of Medicine published To Err is Human, a call-to-action to improve safety in our healthcare system by linking it to greater quality. That seminal work was followed by various reports recognizing the urgent need to transform the clinical trials enterprise by focusing more intently on quality, which leads us to today’s sharp focus on this subject.

  • The Gateway To Study Startup (SSU) Optimization: Performance Metrics
    The Gateway To Study Startup (SSU) Optimization: Performance Metrics

    The sharpening focus on quality management is fueling greater use of standardized metrics to optimize clinical trial performance. Stakeholders are embracing this trend through growing adoption of cloud-based technologies, such as clinical trial management systems (CTMS), source data, and the electronic trial master file (eTMF). The information they generate is flowing into data analytic tools, and with this capability, standardized metrics are gaining mainstream status. 

  • FDA Expectations For Diversity Inclusion In Clinical Research
    FDA Expectations For Diversity Inclusion In Clinical Research

    FDA recently released a snapshot report showing the diversity of clinical trial participants in studies conducted in 2015 and 2016. Out of over 31,000 patients who participated in clinical trials for novel products in 2016, 48% of the study participants were women, which was an increase from 40% in 2015. An increase in clinical trial participation of African Americans was also observed from 2015 to 2016 (i.e., 5% in 2015 vs. 7% in 2016). However, Asian subject participation in clinical studies decreased 1% between 2015 and 2016 (from 12% to 11%, respectively). Overall, the trend towards increasing the diversity of clinical trial participants is encouraging, but a continued effort is needed to keep moving in the right direction.

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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.

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INDUSTRY INSIGHTS

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LIFE SCIENCE INDUSTRY EVENTS

Clinical Study Requirements – Understanding Differences Between the US and EU July 25, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Drug Development 101 – How A Drug Is Made August 3, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
ICH E6 Addendum R2 Team Training and Action Planning August 7, 2017
11:00am- 12:00pm EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
Effective Batch Record Review - Getting It Right The First Time August 14, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Using Social Media for Patient Recruitment in Clinical Trials August 15, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
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TRAINING COURSES

Drug Development 101 – How A Drug Is Made August 3, 2017
1pm-2:30pm EDT, Online Training
ICH E6 Addendum R2 Team Training and Action Planning August 7, 2017
11:00am- 12:00pm EDT, Online Training
Effective Batch Record Review - Getting It Right The First Time August 14, 2017
1pm-2:30pm EDT, Online Training
Using Social Media for Patient Recruitment in Clinical Trials August 15, 2017
1pm-2:30pm EDT, Online Training
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