Oracle

Oracle – Clinical Data Management

PureSoftware is a GOLD partner of Oracle. We have proven capability in Oracle products related to the clinical and drug safety domain through which to drive cost efficiencies in clinical operations. We have also set up a dedicated Centre of Excellence that is capable to cater end-to-end clinical processes using the Oracle product stack.

Oracle Health Sciences InForm Global Trial Management is an electronic data capture (EDC) system used by pharmaceutical and medical device companies to collect data during medical studies. InForm helps clinical research coordinators, trial monitors, clinical data managers, and project managers work more efficiently and with greater accuracy throughout the clinical development process. Its intuitive user interface, multi-language capabilities, and associated software modules deliver a robust solution to meet the needs of today’s global EDC users.

Oracle Argus Safety is an advanced and comprehensive adverse events management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. Oracle Argus Safety also supports a company’s end-to-end pharmacovigilance program by providing a simple and efficient way to comply with international and domestic regulatory safety reporting requirements from clinical trials through post-marketing surveillance

Our services for Oracle Applications includes

InForm Development & QA

  • Form design, Rule Development, and Testing
  • VP Writing and Rules Validation
  • Configuration Testing, Rights and Roles, Sites, Sponsor Users, Time and Event Schedule Testing
  • Portal Setup and Audit, Change Request (CR/CO) and TCC’s Dev and Testing.

Oracle Clinical RDC

  • Form design, Rule Development, and Testing
  • VP Writing and Rules Validation
  • Configuration Testing, Rights and Roles, Sites, Sponsor Users, Time and Event Schedule Testing
  • Portal Setup and Audit, Change
  • Request (CR/CO) and TCC’s Dev and Testing.

Argus 7.0.3

  • Argus Safety Design and Re-engineering
  • Argus Safety Product Development
  • Argus Safety Manual and
  • Automation Testing
  • Argus Safety Implementation

Pyramid & IRT

  • Migrate or Upgrade according to the requirement
  • Portal setup, Integrations like IRT, IVRS, LNMT, CC, DOD, IA, RDE OD, TDE
  • Cognos setup and customer report validation and Testing
  • IRT: Test Scripting, Test Execution (Bug Logging & Regression Testing)

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    Delivering Value for the Last 16 Years

    • Product / Project Ownership Model
    • Outcome / SLA driven
    • Collaborative and Transparent
    • Agile and Flexible
    • Execution Excellence
    • Skin in the Game
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