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DATA MANAGEMENT

SERVICES – DATA MANAGEMENT

DATA GROWTH

Data Management

  • Protocol development/review support.
  • e-CRF design / e-PRO design (Web or Mobile Application)
  • Paper CRF design and printing CRF completion guidelines
  • Development of project documentation: Data Management Plan, Data Entry Conventions
  • Data Cleaning/Validation Plan, Data Management Report.
  • Generation of annotated CRFs following sponsor/Anvi & Gnanvi standards
  • Database design and set-up
  • Database validation with dummy patients
  • Data extraction, mapping, and pooling
  • CRF tracking
  • Data entry (double or interactive mode)
  • Data cleaning: programming checks and testing, query management
  • Medical preferred term coding (MedDRA, WHOdrug)
  • Release of patient profiles and listings
  • Conducting medical reviews
  • Data quality control
  • External data uploading (ECG, CT-Scan, MRI, lab results, drug concentrations, PK data, etc.)
  • SAE reconciliation between the safety database and the clinical database.
  • Regular reporting: metrics, study status
  • Randomization list management
  • Participation in the data/blind review meeting
  • Database lock (interim and final lock)
  • Data transfers
  • DM study file maintenance and archiving

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