Clinical Data Management

Cispact’s Clinical Data Management services are the most efficient and reliable in collection, organization, validation, and analysis of clinical trial data. We at Cispact take our databases and information seriously and are hence, an end-to-end solution provider in the clinical data maintenance field. Our services are integrated in a way to assist right from Phase-I to post-marketing trials. Right from paper CRFs to EDC-based data management projects, the team at Cispact is trained at handling it all with utmost efficiency. We use a comprehensive 21 CFR Part 11 compliant that is user-friendly and commercially available in order to ensure the best integrated and qualitative result.

Study Setup Services

  • Design and Development of CRF/eCRF by
    Following the CDASH Standard
  • eCRF Specification
  • CRF Annotation & Review
  • Data Management Plan (DMP) Creation
  • Database Build & Design and Maintenance
  • Edit Check Specifications & Programming
  • Data Loading Setup
  • Dictionary Setup (MedDRA, WHODRUG,
    COSTART, ICD-9)
  • IVRS/IWRS Integration

Study Conduct Services

  • Reviews Clinical Data for Errors and Trends and Generates Electronic Queries and
    Provide Resolution
  • Medical Coding
  • SAE Reconciliation
  • Third Party Data Reconciliation Post
  • Production Change Control
  • Standard & Customized Reports for Data
  • Review & Metrics
  • Data Transfer

Study Close out Services

  • Data Export/Transfer and Interim Analyses
  • Final DB Lock Readiness
  • QC of Data Base
    Database Audit by QA
  • Database Lock
  • Conversion of Data to SDTM or Sponsor
    Specifications
  • Study Close Out Documentation
  • Clinical Study Data Archival /
    Decommissioning

Other Services

  • Quality and Compliance Check
  • On-Shore and Offshore Clinical Data
    Management Services

 We are committed to ensure best-in-class data quality and a functioning database through transparent mediums, cost-efficient management and quality partnerships. 

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