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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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  • About

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    • Overview
    • Management Team
    • News Highlights
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    • Video Library
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  • Services

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    • Overview
    • Strategic Consulting
      • Overview
      • Clinical Program Planning
      • Statistical Consulting
      • Regulatory Affairs and Operations
      • Technology Solutions
      • Infrastructure Support
    • 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
      • Biostatistics & Programming
      • Medical Writing
      • Pharmacovigilance
  • Experience

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    • Rare Diseases
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  • April 18 2017 Stephen Cropper, MS

    Observations from the MassBio 2017 Annual Meeting

    The Massachusetts Biotechnology Council (MassBio) is a not-for-profit organization focused on supporting and advancing the thriving life sciences “ecosystem” in Massachusetts.

    Continue Reading
  • April 10 2017 LuAnn Sabounjian

    Rare Disease Clinical Development: The Crucial Need for Patient and Parent Involvement

    February 28th, 2017 was the tenth observance of Rare Disease Day worldwide.   Rare Disease Day awareness events took place in over 80 countries through the collaboration of countless foundations and patient advocacy organizations.

    Continue Reading
  • April 7 2017 LuAnn Sabounjian

    A Case Study: Complex Oncology Study and the Boutique CRO that Provides the Perfect Model

    In assembling a team for a new trial studying a rare form of cancer, acute myeloid leukemia (AML), a prestigious cancer research center was looking for a CRO partner with unique qualities.

    Continue Reading
  • April 5 2017 Tahmeena Chowdhury, PhD

    Gene Therapy 2.0

    MIT Technology Review (March/April 2017) lists “Gene Therapy 2.0” as one of the 10 Breakthrough Technologies of 2016.

    Continue Reading
  • April 3 2017 LuAnn Sabounjian

    Reflections on Rare Disease Day 2017

    On a cold, clear Tuesday morning, the State of Massachusetts commemorated the 10th anniversary of Rare Disease Day, which takes place annually all over the world on February 28th, with a celebration at the State House.

    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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