Articles From Our Expert Network

  1. Competencies And Credentialing And Certification … Oh, My! 2/6/2018

    In his recent column, Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP), challenged the industry to address the need to raise the standards of professionalism of the clinical research workforce.

  2. What Improv Comedy Can Teach Us About Communication In Clinical Trials 1/11/2018

    Over the holiday season, I took the time to reflect on the whirlwind and craziness of the past year. I don’t know about you, but I was ready for some comic relief, so I indulged in one of my favorite pastimes -- attending an improv comedy show. It’s been 10 years since the original Whose Line Is It Anyway ended its successful run as a TV show (much to my chagrin), but Saturday Night Live is alive and well after 40 years.

  3. Analyzing The Top Clinical Trial Outsourcing Trends Of 2017 12/28/2017

    In 2017, clinical development services did not witness any significant changes in terms of price index, input cost, and supply-demand gap in comparison to 2016. However, market competition increased, with the supply market seeing continuous mergers and acquisitions, resulting in consolidation and CROs competing for market share in terms of enhanced therapeutic area expertise, geographic reach, full-service capability, technology, and increased functional capability. 

  4. Why Staff-Centricity Needs To Be Front And Center On Your Radar In 2018 11/9/2017

    As 2017 comes to an end, I have been reflecting on the topics I’ve covered this year, focused mainly on patient- and site-centricity.  It occurred to me that as an industry, we’ve been missing the topic of staff-centricity for quite some time.  Patient engagement officers and related roles are becoming more commonplace, and many service providers have a variety of personnel focused on customer engagement.  But it’s rarer to hear about employee engagement officers. 

  5. A Critical Juncture For Clinical Trial Data Management 11/2/2017

    Data management functions are managing a much higher volume and diversity of data in response to the increasing scope and demands of global drug development programs. Real-world data and evidence, electronic clinical outcome assessments, data from smartphones and mobile devices, social media community data, and electronic health/medical records are examples of the variety of new data sources now captured during a clinical trial.  The volume and diversity of data presents integration, compatibility, and interoperability challenges that must be optimized to improve drug development performance and efficiency.

  6. Measuring The Impact Of Reforms On India's Clinical Trial Environment 10/12/2017

    The clinical trial environment in India has seen a downward trend since 2013, when the government approached the Supreme Court regarding the death of 2,644 volunteers during clinical trials over seven years.

  7. Clinical Investigator Payment Best Practices 9/11/2017

    Managing the investigator payment is one of the most challenging aspects of running a clinical trial. Major factors considered by pharmaceutical and biotech companies for investigator payments are therapeutic area of interest, duration of the trial, clinical phase, and patient enrollment.

  8. The 2 Most (Impactful!) Patient-Centric Things That Sponsors Can Do 8/29/2017

    Fall conference season is upon us and a cursory internet search shows no less than a half-dozen conferences focused on the topic of patient-centricity.

  9. ICH GCP E6 (R2) – It's All About Effective Oversight … And Pizza! 7/18/2017

    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.

  10. Surveying The Clinical CRO Market & Outsourcing Landscape 7/6/2017

    The clinical CRO market is defined as the combination of Phases 1 through 4 clinical activities, excluding discovery, preclinical, central laboratory, and post-approval/commercialization services. Within the $34 billion to $39 billion CRO market, the clinical CRO market alone is valued at $25 billion as of 2017, with an expected CAGR growth rate of 7 percent until 2020 (Figure 1). Almost 80 percent of the global CRO market revenue comes from the clinical CRO market.