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Our Services

Services We Provide

Our clients include Fortune 500 companies, clinical research facilities, and universities. Among the services that we provide to these institutions are:

  • Data analysis and programming support of FDA, EMEA, and other regulatory agency submissions, including materials for the preparation of NDAs, PMAs, and 510(k)s.
  • Support for the preparation of submissions for product acceptance by the American Dental Association or other regulatory agencies.
  • Preparation of documentation to support advertising or other product claims.

    We work closely with our clients to evaluate the requirements of their studies, and to design an appropriate package of services to meet their needs. We offer a wide range of services, including the following:

    Statistical Services

    • Study design
    • Sample size / power calculations
    • Randomization
    • Data analysis / interim safety analysis

    SAS Programming

    • Data summary tables
    • Data listings
    • Graphs, charts and figures

    Specialized Applications

    • WinNonlin processing of pharmacokinetic data
    • MedDRA processing of adverse event data
    • Processing of Digitrapper Data from GERD studies

    Data Management

    • Clinical data management using Clintrial 
    • CRF design and development 
    • Data query management
    • MedDRA and WhoDrug Thesaurus coding
    • External data integration with validation
    • Quality and edit checks on client database 

    Study-Related Documentation

    • Statistical reports
    • Clinical Study Reports
    • Statistical Analysis Plans
    • Case Report Form Design
    • Manuscripts
    • Abstracts and presentations

    We're Significantly Statistical®

    In the event of a catastrophic loss of our facilities, our disaster recovery plan is designed to ensure that the complete restoration of data and resumption of processing can take place within 48 hours.