EDC (Electronic Data Capture)
Global IQ has created a unique, proprietary electronic data capture (EDC) system called Internet Data Entry and Management System (IDEMS). EDC is an invaluable tool to decrease the timelines of a clinical study. It is based on our own experiences as well as recognition of clients’ data needs and wants. Oracle-based IDEMS provides a study-unique central repository for all data and allows various quick and easy data management capabilities. IDEMS accelerates studies by making rapid data collection possible, and thus providing the means to formulate quick decisions based on the generation of real-time data reports. Additionally, the utilization of IDEMS saves our clients the expense of purchasing their own data management hardware or software.
Some basic information on the IDEMS software and client interface:- Internet accessible
- All interfaces are tailored to a specific study
- Secure- 128 bit encryption (i.e. the same security features that banks utilize) requiring logons and permissions for users
- GMP compliant with respect to its development, design, and validation
- Highly user friendly, with a step by step wizard for data entry and review
- Toll-free customer support for all clients
- Central Repository – access to study data and progress
What IDEMS and our data management and biostatistics teams offer clients:
- Real-time, true central data monitoring
- The ability to uniquely configure all study input based on the specific study protocol
- Query abilities and the subsequent creation of relevant data reports
- Rapid data lockdown
- Financial tracking capabilities
- Database design and development
- CRF design, development, and tracking- specific to each client’s needs
- Data validation and quality control
- Simplistic data entry
- Electronic data transfer
- Adverse event (AE)/concomitant medication coding
- Serious adverse event (SAE) management with expedited reporting methods
- Interim analysis
- Data archiving and backup
- Document archiving
- Report tables
- Multiple data export formats
- Visit and CRF tracking
- Enrollment tracking
- Primary and secondary outcome tracking
- Sample size calculations
- Statistical analysis plans
- Randomization
- SAS programming
- Data analysis and interpretation
- Statistics reporting or data during any stage of the study
- Generation of final study reports
- Web-based data listings including enrollment status, efficacy endpoints, study newsletters
The aim of IDEMS is to provide the most rapid and cost effective process for the completion of clinical studies, while still maintaining a commitment to excellence and satisfaction.