Clinical Data Management

Clinical data management team focuses on the generation of high-quality, reliable, and statistically sound data from clinical trials. We have extensive experience in all therapeutic areas of data management from Phase I-IV clinical trials. We provide end to end clinical data management solutions from data management plan to database lock.

CRF Design & Annotation
  • Define standard modular CRF library
  • CRF design for EDC, paper, or scanned formats (CTMS, EDC/CDMS, IVR and submissions management)
  • Professional review of study protocols and alignment of CRF and protocol
  • CRF completion guidelines based on the protocol
  • Automatic annotation of blank CRFs for CDISC SDTM
  • Automatic annotation of scanned paper CRFs for indexing
  • aCRFreview
Database Management
  • Implement CDISC CDASH (Clinical Data Acquisition Standards Harmonization) standards in database design
  • Data Management Plan (DMP)
  • Data Validation Specification (DVS)
  • Coding of medical terms according to scientific dictionaries (MedDRA and WHODRUG)
  • Query Management
  • Reconciliation of Laboratory/Vendor/ or any external data
  • Data transfer to the client along with metadata and data consistency reports
  • SAE Reconciliation
  • Database lock
  • Electronic data transfers from 3rd parties (e.g. central lab, PK, ECG data)
  • Superior quality control and assurance
  • Rapid database closure

Data Entry
  • Establish clear data standardization rules
  • Independent double data entry with interactive reconciliation and quality control

  • Conduct Data cleaning

  • Generate audit trail
  • Central laboratory database imports
  • Incorporating third-party databases
  • Import & export CDISC ODM XML in database
  • Checks are run during data entry, either as the data are entered or at intervals. Invalid results are fixed or allowed using the planned procedures

Database Documentation, Tracking & Reporting
  • Creation and maintenance of data management documents
  • Status reports and administrative listings
  • Automatic edit checking and query tracking
  • Dashboards for study status
  • High-level reports for data consistency and integrity
  • QC/QA documentation for project-specific guidelines and SOPs
  • Study documentation