Oracle Clinical Remote Data Capture (OC RDC)

Oracle Health Sciences CRO Advantage Silver Level Partner

OC RDC is a fully integrated system for both paper and electronic data capture (EDC) studies.

Features

  • The database design and user interface accommodate studies with multiple treatment arms and cohorts with different assessment schedules and frequencies. The system provides the ability to define multiple potential pathways a patient might take through a complex study and display only the relevant eCRF pages expected for the patient, based on reported patient data.
  • Embedded data management workflows allow discrepancies to be managed efficiently by Data Managers. In RDC, the discrepancy data management capabilities provide systematic color-coded routing to specific study personnel.
  • Hybrid studies (paper and EDC) are supported by using the same study definitions, same page layouts and same integrated database for both EDC and paper environments. This facilitates transition from a very small Phase I study in paper to a larger EDC study in Phase II or III.
  • Sophisticated edit checks across all eCRF pages can be implemented for very complex studies.
  • Images can be embedded into eCRFs.
  • Complete control over protocol amendments is provided. The rollout of amendments to sites can be carefully staggered and scheduled in accordance with local regulatory timelines.
  • New databases, CRFs or eCRFs can be fully debugged in a Test Mode prior to committing them to Production Mode.
  • Page elements can be saved in a Global Library for use on new studies.
  • Data is easily exported to SAS data sets for statisticians. This can support interim analysis.
  • Built on powerful and robust Oracle technology, OC RDC has proven scalability and performance, having successfully supported thousands of clinical studies throughout the global clinical trial industry. These have included studies in all development phases and vast patient populations, with submissions approved across many therapeutic areas and geographies.
  • Medical coding with the latest MedDRA and WHO Drug dictionaries is fully integrated. Coding is automatic yet can be defined specifically for:
  • drugs
  • therapeutic areas
  • sponsors
  • geographic regions
  • Uses a state-of-the art Oracle 11g 64-bit database
  • ClinDatrix performs dictionary upgrades annually under change control, thereby maintaining full validation of the system.
  • A self-paced e-learning system ("TrainDatrix") is utilized for training clinical site personnel, sponsors and CRAs in the use of the system.

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