Phone: +91-40- 64538805 || Email: info@carakaacts.in

Our Clinical Data Management service has been trusted by numerous global pharmaceutical, biotech and device companies. Renowned for its excellent planning and the utilization of latest technology, the data management team ensures high quality data, quick turnaround time and accelerated solutions for our clients.

Services

  • CRF designing
  • Database designing and study setup
  • Data entry
  • Clinical coding with industry standards and client-specific dictionaries
  • Reconciliation of external data
  • Data validation and query resolution
  • Project management of data and technical services

  Data analysis

  • Creating tables, listings and graphs as per regulatory compliance
  • Generating reports and documentation as per regulatory requirements

Caraka Clinical 7 Translational Sciences  offers a full range of Clinical Data Management services including:

STUDY START-UP PLANNING AND DEVELOPMENT

  • Project timeline development and maintenance
  • CRF development, based on protocol requirements
  • Data Management Plan component development
  • Project Notebook development and maintenance
  • Data validation document development
  • Self evident correction document development
  • Test, review and approve database and data entry screens
  • Test, review and approve validation procedures

 DATA ENTRY, SCANNING AND INDEXING

  • Scanning and Indexing of paper CRF pages
  • Study Subject position data entry into Oracle Clinical™ database
  • First pass and second pass entry into Oracle Clinical™ and verification
  • Receipt, tracking and temporary storage of CRF pages
  • Data entry guideline development

 STUDY CONDUCT

  • Discrepancy management in RDC studies
  • Data listing review for data cleaning and monitoring
  • Discrepancy resolution oversight/QC
  • Discrepancy review paper studies
  • Data Clarification Form (DCF) distribution
  • DCF resolution
  • Reporting using Oracle Discoverer™, Integrated Review, and Business Objects
  • External vendor data review and discrepancy processing
  • Lab data review

 DATABASE LOCK AND VALIDATION

  • Database lock plan development
  • Quality control check of project database prior to database lock
  • Completion of database lock documentation