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    A Critical Look at Inclusion & Exclusion Criteria

    A Critical Look at Inclusion & Exclusion Criteria

    Based upon US FDA Workshop Report April 16 2018 In response to the FDARA( Food and Drug Reauthorization Act) of…

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    Developing a Training Program at your Institution- The 7A Model

    Developing a Training Program at your Institution- The 7A Model

    So you need to implement a training program at your organization…where do you even begin? Training/learning programs can exist in a…

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    Expanding Technology in Clinical Trials Fosters Process Improvement

    Expanding Technology in Clinical Trials Fosters Process Improvement

    The pharmaceutical sector has been slow to adopt technologies designed to boost efficiencies in the very complex business of developing…

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    FDA Common Rule- A Much Needed Update

    FDA Common Rule- A Much Needed Update

    In a sweeping gesture to better protect human research subjects, sixteen US federal agencies issued a revised Common Rule on…

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    FDA Releases GCP E6 R2 Guidance

    FDA Releases GCP E6 R2 Guidance

    Released by the International Council on Harmonisation (ICH) in November 2016, Good Clinical Practice’s second revision, R2 has been making…

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    Clinical Research Conferences 2018

    Clinical Research Conferences 2018

    Which Clinical Research Conferences to Attend in 2018? Happy new year and welcome to 2018! As the clinical research industry…

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    Quality Management in Good Clinical Practice (GCP) E6 R2 Update

    Quality Management in Good Clinical Practice (GCP) E6 R2 Update

    Good Clinical Practice GCP E6 R2 Update The largest addition to Good Clinical Practice in Release 2 is the addition…

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    Investigator Oversight: Changes in Good Clinical Practice November 2016 Update

    Investigator Oversight: Changes in Good Clinical Practice November 2016 Update

    In the first update to Good Clinical Practice E6 since 1996, Release 2 introduced 26 major additions to the gold…

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    GCP E6 R2 Addendum; Impacts for Investigators and Clinical Research Sites

    GCP E6 R2 Addendum; Impacts for Investigators and Clinical Research Sites

    Adopted in November 2016, the second revision to ICH Good Clinical Practices E6 R2, is the biggest revision to GCP…

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    5 Tips to Boost Patient Recruitment at your Research Site

    5 Tips to Boost Patient Recruitment at your Research Site

    As a clinical research site you are undoubtedly constantly being approached by your sponsors inquiring about enrollment at your centre.…

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    Protocol Scoring and Determining Study Load per Clinical Research Coordinator

    Protocol Scoring and Determining Study Load per Clinical Research Coordinator

    Guest Author: Christina Talley, MS, RAC, CCRP, CCRC Program Director, Office of Strategic Research Initiatives Houston Methodist Research Institute Due…

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    6 Tips to Boost Patient Recruitment in your Clinical Trial

    6 Tips to Boost Patient Recruitment in your Clinical Trial

    Sluggish patient recruitment is costing the clinical research industry hundreds of millions of dollars in missed opportunity costs. These costs…

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    Mastering the Informed Consent Discussion

    Mastering the Informed Consent Discussion

    Overview of Informed Consent Informed consent is the process through which a potential subject is informed about a clinical research…

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    Leveraging Clinical Trial Pre-Screening and Screening Data

    Leveraging Clinical Trial Pre-Screening and Screening Data

    Sponsors have long debated whether or not to collect pre-screening and screening data for sites participating in their trials. Understandably…

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    Utilizing a Patient Recruitment Specialist

    Utilizing a Patient Recruitment Specialist

    The Patient Recruitment Specialist (PRS) is a fairly new and emerging role in the clinical research industry. Their role varies…

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