Our data management staff includes clinical data managers, database developers, data entry specialists, medical coders, biostatisticians and we have extensive systems’ support capabilities.
Our comprehensive team develops data management and data quality plans during project start-up. These procedures ensure accurate and consistent data collection, management, auditing, cleaning and documentation.
Our clinical data management team is using the most advanced and comprehensive clinical data management software which meets the regulatory standards to ensure auditable GCP quality results to keep your drug development and medical device programs on track.
Our DM services:
- Case Report Form (CRF) and Database Design
- Clinical Data Management Plan and Validation Rules
- Electronic Data Capture (EDC) and Double Data Entry
- Data Cleaning and Query Management
- External Data Handling (Data Import/Export)
- Dictionary Services (MedDRA& WHODD)
- SAE Reporting and Reconciliation