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Clinical Info Framework
With the evolving needs of clinical trials and regulatory compliances, Life Sciences companies face difficulty in utilizing one integrated product for all their various needs. Looking at the strong demand for customized and integrated e-Clinical solutions, our software consultants have gained expertise in developing custom and integrated e-clinical solutions using Service Oriented Architecture.
DDi leverages its strong functional background and technology expertise to deliver e-clinical solutions, which are in compliance with 21 CFR Part 11 and other regulatory guidelines.
- Electronic Data Capture System (EDC)
- Clinical Trial Management Systems (CTMS)
- Clinical Data Management Systems (CDMS)
- Drug Safety Systems (AERS)
- Electronic Patient Report Outcomes (ePRO)
- Interactive Voice/ Web Response Systems (IVRS/ IWRS)
Key Features:
- Hybrid models (paper CRF and eCRF)
- Double data entry
- Study design & Set-up
- Single and multi-site management
- Edit checks
- Medical coding
- 21 CFR Part 11 compliance
- Audit Trail
- Discrepancy management
- Patient Randomization
- Logistics Support
- Data exports in SAS, CDISC, Excel, etc.
- Document Sharing
- Multi-lingual
Key Benefits:
- Easy to use
- Cleaner and faster data
- Effective system validation and regulatory compliance
- Custom integration
- 24/7 and 16/5 multi-lingual helpdesk support
- Beneficial for long-term and complex clinical trials
Our Strengths:
- CRO domain experience
- Technology competency (Microsoft, Oracle, SAS)
- Integrated clinical and technology services
- Flexible pricing and delivery models
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