Octalsoft EDC, a web-based and mobile enabled solution, provides a simple user interface to capture patient data in a compliant manner. With integrated online edit checks and query management features, you can capture clinical trial data faster and accurately. Octalsoft EDC maintains a complete audit trail ensuring compliance with 21 CFR Part 11 requirements and reducing risk across clinical development phases.
Octalsoft EDC’s powerful reporting capabilities help study teams visualize and analyze study data in real-time. By leveraging open standards, it allows for easy integration of clinical and non-clinical data from multiple sources. The flexible and scalable Octalsoft EDC modular solution finds patronage across the complete spectrum of clinical research community including, Pharma, Biopharma, Medical Device manufacturers, CROs, and Sites.
Why Octalsoft EDC?
- Simple and secure data collection with online validation for assured accuracy
- Study designer to set up complex studies
- Maintains complete Audit trail
- Multiplatform, multidevice support including smartphones and tablets
- Faster submissions for regulatory approvals
- Online integration of complex, multi-axial, hierarchical medical dictionary
- Online collaboration to ensure prompt addressing of data discrepancies
- Complies with regulatory requirements like 21 CFR Part 11 and HIPAA regulations
- Adheres to independent industry standards like CDISC enabling harmonization of clinical data