Clinical Data Management

  • Home
  • /
  • Service Details

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 SET UP SERVICES



  • Design and Development of CRF/eCRF by following the CDA
  • Complying to the SH standard
  • eCRF Specification
  • CRF Annotation & Review
  • Data Management Plan (DMP) Creation
  • Database build, design and maintenance
  • Edit and check specifications & programming
  • Data Loading Setup
  • Dictionary setup (MedDRA, WHODRUG, COSTART, ICD-9)

STUDY CONDUCT SERVICES



  • Clinical data reviews for errors and trends
  • Generation of electronic queries and providing resolution
  • Medical Coding
  • SAE Reconciliation
  • Third party Data Reconciliation Post-Production Change Control
  • Standard & Customized Reports for Data review & Metricst
  • Database Transfer

STUDY CLOSE OUT SERVICES



  • Analysis on data export/transfer and interim
  • Final DB lock readiness
  • Quality Control of Database
  • Quality Assurance through Database Audit
  • 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 off-shore 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. "