Data Management
The proper data can guide you to the
way beyond the numbers.
give you the insights enhancing operational effectiveness.
From the clinical data recording to reporting, we provide clean, transparent and accurate data management. We make recommendations on the most cost-effective approach for all phases of clinical trials. Our goal, providing reliable data with speed and accuracy, would mean to you who need to achieve successful outcomes and minimize timeline risks. High quality and meaningful data mean that you can make proper decisions earlier in the trial. From building database to locking it down, leave it to us and complete your trial faster and safer.
- Data Management Plan (DMP) writing and maintenance
- Data Validation Plan (DVP) establishment
- Design & Development of Case Report Form (CRF) / e-CRF & annotation
- Electronic Data Capture (EDC) applications setup across major EDC
- platforms & EDC data management
- Medical Terminology Coding using MedDRA, WHOART, WHODD
- Reconciliation of Adverse Events and Serious Adverse Events
- External Data Management
- Database Quality Check
- Database Lock
- Study Data Transfer
- Full EDC integration & CDISC compliance
- Complete validated systems & environment (21 CRF Part 11, ICH compliance)
- CDISC SDTM database conversion programming
