Data Management

Our Data Management department is fully compliant for 21 CFR Part 11 and has capability to deliver extensive clinical data management projects. Our team ensures successful high quality data delivery by keeping your clinical development program on schedule throughout. Our team remains involved at every stage of data management and works closely with study sites to generate clean datasets with total quality. Our team comprises of data management executive, data entry operator, data manager and medical coder along with internal data quality control executives.

Our data management team can manage multi-center, multi-country studies in both electronic and paper based format. We are specialized in managing the following Data Management activities:

  • Paper CRF/eCRF Development and Database Design
  • Data Management Plan
  • Data Entry, Verification and Validation
  • Double Data Entry (paper CRF)
  • Coding in MedDRA and WHO DD
  • Query Resolution and Database lock
  • Design Safety Database
  • SAE Reconciliation
  • Electronic Data Integration
  • Customised Data Listings

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