Who We Are

GCE is a corporate member of CDISC, and our services are fully compliant with CDISC standards. GCE provides expert CDISC services and solutions tailored to our client’s specific needs.

Our CDISC team comprises of certified CDISC members who are actively involved in CDISC leadership teams and initiatives.  We are specialized in CDISC data conversion, implementation of CDISC standards, and CDISC compliance checking.

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What We Provide

Our in-house experts provide services for:

    • Gap Assessment
    • Strategic Consulting
    • Data Standards Development
    • Compliance strategy
    • CDISC Standards Implementation
    • Standardizing legacy data models and Data conversion
    • Training of CDISC standards
    • Governance

Ongoing study data into CDISC compliant:

    • CDASH Compliance
    • SDTM and ADaM
    • OpenCDISC Validation
    • Define.xml/Define.pdf

Why GCE?

FDA will require submissions to be in CDISC-compliant formats by 2017. GCE offers strategic implementation and support services for CDISC compliant projects that include both consultancy and mapping of multiple studies to CDISC standards. Since the inception of our CDISC support in 2009, our team has successfully submitted a large number of studies with none rejected to date. We maintain this level of accuracy by staying updated on regulatory fluctuations and engaging in CDISC conferences, PhUSE working group, and PharmaSUG industry groups.

Refer to the Why GCE? page for more reasons to choose GCE for your project!