Data Management

All Services

The clinical data management team is involved in all aspects of the clinical trial process, from protocol development through report writing checks/ data definitions are implemented industry recognized and accepted data management systems which enable us to deliver high-quality outputs with confidence. It provides direct, on-line access to a project-specific database allowing on-screen generation of various reports, set according to the customer’s requirements.

 

The data management experience across a broad range of therapeutic areas, using both paper and EDC systems. The Data Management group applies quality norms and procedures to complete complex clinical programs successfully. The expert trained resources ensure that each study is accomplished using the efficient technologies available.

  • CRF Design
  • Database Design (Paper/EDC)
  • Data Entry/Data Validation
  • Medical Coding
  • SAE Reconciliation
  • Query tracking
  • Medical Review
  • Protocol Violations

The Data Management team flexibility to provide customized services in order to meet the timelines and project goals set by the client’s team, which includes but not limited to:

Data Management Consulting

  • Trial initiation
  • Trial conduct
  • Trial Close-out
  • CRF/eCRF Design (experience in CDASH standard)
  • Ongoing support during the clinical trial, including customized status reporting and data listing
  • Evaluation and validation of EDC tools
  • Implementation and development of new EDC tool
  • Migration Service for EDC tools
  • Custom training