Clinical Data Management

The present day Life sciences industry demands flexible solutions to accelerate the drug development process on one hand while reducing costs of the clinical development process on the other.

Wipro realizes the significance of clinical data management in the development process. We offer cost-efficient clinical trial data management solutions abiding by the regulatory compliance requirements. Wipro blends its IT expertise, process optimization and business process support services to provide a complete array of customized solutions. The focus is on seamless transformation of raw data into accurate and reliable throughput.

Wipro offers remote clinical trial data management services in an FDA / EMEA compliant secure environment as well as offshore CDM centers. It incorporates stand-alone services to vast outsourcing support frameworks. Our service offerings include:

Basic Services

  • Case Report Form (CRF) design
  • Database design and study setup
  • Data entry and verification from multiple sources including paper, EDC, fax, voice and phone
  • Online data validation and query resolution services for remote access and rapid query turnaround
  • Medical coding with MedDRA and other dictionaries
  • Protocol-wide database integration including legacy data, and standardization with new coding dictionaries

Statistical Services

  • Statistical analysis plan design
  • Sample size calculations
  • Randomization schedule design
  • Interim analysis
  • Exploratory analysis and statistical modeling for efficacy and safety evaluation of drugs
  • Statistical support for publications and post marketing analysis
  • Integrated analysis of efficacy and safety

SAS Programming Service

  • Creation of analysis database
  • Edit checks and database clean-up
  • Program summary tables, listings and graphs