Clinical Data Management

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EDC BUILD

DESIGN/CREATE & TEST CLINICAL DATABASES ​
  • Forms, Folders, Matrices, Data Dictionaries, Unit Dictionaries, Edit Checks, Derivations, Custom Functions, Standard and Custom Reports
  • Batch Data Loading, Lab Set-Up & Assignment, Dictionary Assignment
  • QC of Clinical Database prior to Production
  • Post Production Database Changes and Respective Impact Analysis

CLINICAL DATA MANAGEMENT

DATA VALIDATION & RECONCILIATION
  • Clinical Data Validation & Third Party Data Reconciliation (SAE, lab data, PK/PD, etc)
  • Write eCRF & Edit Check specifications, Data Management Plan and related DM Docs.
  • UAT of eCRF Build and Programmed Data Validations
  • Clinical Trial data Interim & Final Analysis
  • Close-out Audit for closing of Study Trial

TEAM OF CERTIFIED PROGRAMMER

  • CDMS including, Oracle Clinical RDC, Medidata RAVE, InForm (Central Designer), Medrio, Castor, PheedIT, DSG.
  • Global Library Creation for Clients in the various CDMS.
  • Time bound complex Phase II& III Migration Studies, (e.g. legacy databases to Medidata and InForm).

EDC TOOLS EXPERTISE

  • Oracle Clinical RDC, Medidata RAVE, Inform CD (Central Designer), Medrio, Castor.
  • From inception to completion including Case Report Form (CRF) Designing, CRF Annotation, Database Designing, Data Validation, Discrepancy Management, Medical Coding, Data
  • Extraction & Database Lock.
  • Handled large & complex trials (e.g. subject# 7000- 10,000) and ensured the timely data quality.

CDM Services

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