Clinical Data Management

You focus on running a high-quality program. We’ll handle the data.

Are you looking to add capacity or new services? Quartesian delivers top-notch, low-cost resources so you can win business and maintain margin. Are you looking for data support? Quartesian augments your staff and expertise to keep your trial on track and under budget.

Quartesian’s data management processes are 21 CFR Part 11 compliant and user-friendly — ideal for paper CRFs, EDC-based projects, and rescue studies. We start by deploying a data capture system, then build the study database, review and verify data, and format it for submission to regulatory authorities — with database lock on or before deadline — every time.

CDISC Gold Membership
Medidata Rave Partner
Medrio Enterprise Partner
SAS Certification

Data Management Planning

  • Data management plan creation and maintenance
  • Data entry guideline / eCRF completion guideline creation and maintenance
  • Site / CRA EDC training
  • CRF / eCRF design
  • Implementation of current data standards (SDTM, CDASH, and other CDISC standards)
  • Customized clinical data management programming
  • Data management consulting

Data Management Services

  • Data entry and tracking
  • Data conversion to proprietary data specifications
  • Process and resolve queries
  • CRF review and validation
  • Third-party data integration
  • Medical coding and serious adverse event (SAE) reconciliation
  • Clinical trial rescue services

Database Configuration

  • Database development, testing, and deployment
  • Database closeout and delivery
  • Clinical database exports and interim analyses
  • User access management
  • Customized status reporting and data listings

Studies We Work On

  • Non-Human / Animal Studies
  • Early Phase Drug Development Studies
    • First in Human Studies
    • Vasoconstriction Studies
    • Dose Identification Studies
    • Pharmacokinetic / Pharmacodynamic Studies
    • Bioavailability / Bioequivalence Studies
  • Late Phase Drug Development Studies
    • Pivotal Studies
    • Post Marketing Studies
    • Registry Studies
  • Medical Device Studies
    • Pilot Studies
    • Pivotal Studies
    • Post-Approval Studies

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