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Latis provides complete data management services, from the design of the CRF to the database lock.
Latis can provide both electronic and paper CRF even in a mixed system. The company uses 21 CFR part 11 compliant tools with electronic audit trail of all access to the database and eCRF.
  • Data Management Plan
  • CRF Design and Production
  • Annotated CRF
  • Database Design and Validation
  • Data Entry Screens
  • Remote Data Capture
  • Programming and Validation of Data checks
  • Query Management for paper-CRF and e-CRF (electronic and manual queries)
  • Expert Coding using MedDRA
  • CDISC-CDASH standards for data collection
  • Laboratory Data Management
  • Data Validation Plan
  • Data Validation and Cleaning Programs
  • Paper and electronic CRF Log and Tracking
  • QC of CRFs/DCFs versus Database
  • Database lock
  • Preparation of tables for statistical analysis according to CDISC-ADaM
  • Migration of database to CDISC-SDTM for submission
  • Database Transfer according to Sponsor's requirements
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