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Recent Posts

  • Global Trial Challenge: Data Quality and Integrity
  • From Envelopes to AI: The Evolution and Future of IRT in Clinical Trials
  • AI-driven Tools Enhance Data Management
  • Paper vs. Electronic: Patient Reported Outcomes in Clinical Trials
  • eTMF Maintenance: Best Practices for an Inspection-Ready eTMF
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    • Overview
    • Management Team
    • News Highlights
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      • Overview
      • Clinical Program Planning
      • Statistical Consulting
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    • Full Service
      • Overview
      • Phase
        • PRE-IND
        • IND
        • Phase 1-3
        • NDA
        • Phase 4
      • Global Capabilities
      • Protocol Development
      • Adaptive Design
      • Decentralized Clinical Trials
      • IDMC Services
      • CDISC SDTM & ADaM
    • Functional Services
      • Overview
      • Clinical Operations
      • Data Management
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  • March 29 2017 Tahmeena Chowdhury, PhD

    Perspectives from the Medical Writing Team

    “The Cancer Lottery” in MIT Technology Review (January/February 2017) provides an excellent overview of precision medicine in treating cancer by following the journey of an artist living with cancer for over 30 years.

    Continue Reading
  • March 27 2017 Stacy Surensky, CPC

    Focus on Personalized Attention and Customized Reporting

    A small biopharmaceutical company with big aspirations and unlimited potential was not getting the personalized attention that they expected and deserved from their large CRO. Instead, their needs often took a backseat to the needs of larger organizations, which, in some cases, led to frustrating delays.

    Continue Reading
  • October 25 2016 Kathy Zheng, MPH

    Are Digital Health Technologies Worth It? A Frank Assessment.

    Without question digital health technologies are revolutionizing clinical development and execution. From electronic patient reported outcome (ePRO) systems to wearable devices, they can, when used properly, provide many benefits.

    Continue Reading
  • July 22 2016 Stacy Surensky, CPC

    The Continuing Evolution of the Clinical Data Manager Role

    Last year in our blog post titled “The New Clinical Data Manager,” we wrote about some key changes to the clinical data manager role that have taken place in recent years.  What is fascinating to me is the pace at which the versatile position continues to evolve.  

    Continue Reading
  • December 18 2015

    The Clinical Study Report – Changing at Its CORE?

    All the activity of a clinical study culminates in the production of a clinical study report (CSR). More than a written summary of the results of a study, among its contents are the protocol followed during study conduct, lists of investigators, and the statistical output and methods. If printed, a CSR could number 1000 pages or more.

    Continue Reading
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Recent Posts

  • Global Trial Challenge: Data Quality and Integrity
  • From Envelopes to AI: The Evolution and Future of IRT in Clinical Trials
  • AI-driven Tools Enhance Data Management
  • Paper vs. Electronic: Patient Reported Outcomes in Clinical Trials
  • eTMF Maintenance: Best Practices for an Inspection-Ready eTMF
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    • Overview
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    • NDA & MAA Regulatory Submissions
    • Rescue Projects
  • Giving Back
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