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Data Management

Our years of providing data management services for an academic medical center serve our customers well. We have a thorough understanding of how clinical trials work, with several hundred research studies and funded clinical trials dependent on our data every year.

As a result of this experience, we not only ensure that you obtain the error-free data you need, we are also able to provide fully validated systems and procedures by subject matter experts.

  • Robust, compliant and well-established system. Our ClinAxys® II System is regarded as one of the industry standards for multi-center trials.
  • Data Transfer Agreements. A Data Transfer Agreement is established for every project to specify the project data requirements, delivery mechanism and frequency. Customized data integrity checks prior to transfer can be put in place to ensure clean transfers.
  • Flexible data formats and delivery methods. SAS dataset, ASCII (delimited, fixed width) data files, CDISC format and client specified formats are available. Delivery method options include eCRF integration with unidirectional or bi-directional interface, FTP to sponsor databases/server, and secure/encrypted email file attachments.
  • On-line results access. Laboratory results are also available through WebAxys® on-line results for Sponsor and/or CRO project team. Link to WebAxys®
  • Data Quality and Integrity. The ClinAxys® II System supports data quality by establishing and enforcing project specific parameters for:
    • Visit and testing schedules
    • Unique kit ID numbers linked to study and Investigator sites
    • Subject demographics and ID schema
    • Duplicate, blinded, independent data entry of subject information
    • Study specific reference ranges
    • Study specific delta checking
    • Inclusion, exclusion, and withdrawal flags