ELECTRONIC DATA CAPTURE: A COST-EFFECTIVE E-SOLUTION FOR YOUR CLINICAL RESEARCH PROGRAM
Electronic Data Capture enables site staff and clinical monitors to capture data with greater accuracy. It allows you to have quick and remote access to data and a robust reporting library to manage your trials more effectively. In addition, time from first patient enrolled in a study to database lock is significantly decreased by streamlining the data validation process and automating query resolution.
A Complete Range of Clinical Data Management Services
- Case Report Form design using CDASH standards
- Database design, programming, and maintenance
- Data validation programming and testing
- CRFs annotated to CDASH standard
- Data entry with experienced data entry staff
- Data cleaning and query management
- Data management status reports
- Medical coding using the WHO Drug Dictionary Enhanced and MEdDRA dictionaries
- Management of external data received from specialized vendors (e.g., Central Laboratory, ECG, PK, PD)
- Medical review, computerized edit checks, and queries management
- Serious adverse event (SAE) reconciliation
- Integration and verification of external electronic data
- CRF / eCRF completion end user training
- Database QC, protocol deviations listing
- Data review meeting, Database lock
- Data transfer based on sponsor specifications (ASCII, SAS®)