Clinical Data Management

Our Clinical Data Management service has been trusted by numerous global pharmaceutical, biotech and device companies. Renowned for its excellent planning and the utilization of latest technology, the data management team ensures high quality data, quick turnaround time and accelerated solutions for our clients.
 
Key features

  • SAS Suite PheedIt
  • SAS Analytics
  • 21 CFR Part 11 compliant systems
  • ISO 27001:2005 certified for Information Security Management System (ISMS)
  • Over 90 employees with 5-10 years of domain expertise
  • Electronic data capture (EDC) platform encompassing 60 countries
  • Extensive experience in sponsor hosted technologies

Services

  • CRF designing
  • Database designing and study setup
  • Data entry
  • Clinical coding with industry standards and client-specific dictionaries
  • Reconciliation of external data
  • Data validation and query resolution
  • Project management of data and technical services
  • Data analysis
    • Creating tables, listings and graphs as per regulatory compliance
    • Generating reports and documentation as per regulatory requirements