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eCRF & Data Management Services
FromIntegra IT
The best cost-benefit eCRF and easy-to-set web solution in the market. Combined with our TriaPal ePRO and/or eCOA mobile solutions and Clinical Data Management capabilities, our services of Electronic Data Capture (EDC) excel in deliverables, timing, and quality. We foster high levels of efficiency, ensuring transparency, data integrity, and data quality.
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- Subject Enrollment
- Data Entry
- Randomization Module (IRT)
- Data Verification
- Reports
- Query Management
- Electronic Signature (PIs)
- Detect early risks; allowing the user to implement early mitigation
- Monitor open queries and alerts to the site
- Ensure data quality.
- Generate better outcomes.
- Fast and accurate
- Efficient decision-making.
- Built-in medical dictionaries: MeDRA and WHO
- Develop eCRF, EDC, and variable programming according to CDASH and SDTM
- Query validation and testing
- Development of Data Management Tools (DMTLs), Web Reports, BI tools, and user requirement specifications.
- Patient data audit trail to ensure timely and quality entry into the EDC system.
- Testing of study database
- CRF completion (data entry %, Verification %, PI Signature %)
- Adverse Events and Serious Adverse Events coding
- Database high-security standards for transfer and backup.
- CRF Configuration document
- CRF form definition document
- Edit check and self-evident correction definition (where all checks reviewed in data cleaning are defined)
- Annotated CRF (CDASH-SDTM)
- CRF project user guide
- CRF manual per role (Data Entry, CRA, PI)
- Data Management plan (DMP)
- Final Data Export
- Query aging reports
- CRF completion reports (data entry %, Verification %, PI Signature %)