Clinical Data Management

Capturing quality clinical trial data is the key to ensuring patient safety and confirming efficacy in clinical development today.

We provide data management services from study start-up to database lock within mutually agreed timelines, also ensuring data quality and integrity. Our CDM team guided by standard procedures, will analyse the data collection requirements from clients, implement different effective strategies, and thereby provides the best solution in a quick, reliable, and cost-effective manner. The team has rich experience in handling various industry benchmark EDC tools such as Inform, RAVE and Veeva tools to design and review Case Report Form (CRF), visualization and reporting tools such Spotfire and J-Review.

Our expertise sways beyond traditional CDM services and our capabilities include risk-based monitoring, medical coding and automation across therapeutic areas including vaccines and experience in managing various phases of a clinical trial.

Our project management capabilities have been our strength with risk management experience, robust communication framework, enhanced data security and business continuity readiness, people friendly culture all leading to achieve our goal of exceeding customer expectations.

EXPLORE OUR CLINICAL DATA MANAGEMENT SERVICES:

  • Consulting (strategic program planning, protocol review, EDC selection, etc.)
  • Protocol design and review
  • Case Report Form (CRF) design utilizing the current CDASH and SDTM standard
  • Database setup / design, validation, and maintenance
  • Data validation programming and testing, inclusive of derivations, edit checks, custom functions, and manual review listings
  • Coding of diagnoses, AEs, and drugs

  • Local laboratory administration with the EDC systems
  • Database lock and archiving
  • Data transfer and integration
  • Data visualization and reporting
  • Overall study management