Data Management

GRC provides comprehensive support for all phases of clinical trials through:

  • Experienced Biostatisticians
  • Experienced medical writers
  • SAS
  • KineticaTM release 4.4.1

GRC offers comprehensive Data Management capabilities to handle all clinical data generated from a trial. GRC has the expertise and capabilities to fulfill your specific data management requirements and provide clarity to your study data.

 

OUR SERVICES ARE

  • CRF Design (including completion guidelines), annotation, printing
  • Handling of CRFs and Data Clarification Forms (DCF)
  • Data Management Status Reports
  • SAE Data Reconciliation
  • Database Lock
  • Database Setup
  • Data Collection
  • Protocol writing and study design
  • Case Report Form design
  • Sample size estimation and randomization
  • Data Entry services
  • Adverse event coding and reporting
  • Biostatistics, pharmacokinetic and pharmacodynamic modeling and reporting
  • Clinical trial reports
  • Non-clinical and clinical expert reports as per Module 2.4 and Module 2.5
  • In-vitro / In-vivo correlation (IV / IC)
  • Statistical consultation
  • Electronic submissions
  • Building the eCTD
  • Archiving