Clinical Data Management

MED DEVICES CDM is focused on thoroughly understanding data interchange standards for health care research to help streamline the collection and exchange of clinical trial data with joint venture partners, clinical research organizations and regulatory authorities. We are uniquely positioned to provide following data management services in the regulatory environment because of our SOPs, US FDA: 21 CFR Part 11 compliance and Computer System Validation & Implementation experience within the global industry.

Our approach is to provide our clients with clinical data management solutions that are customizable to client requirements, cost-effective, secure, compliant to applicable standards and expedite the data collection process, regardless of the data collection method our clients choose.

Data Management Services include:
- Protocol review.
- CRF Design, review and production.
- Database setup and maintenance.
- CRF logging and tracking.
- Data entry/verification.
- Clinical Data validation/review/trend analysis.
- Medical coding.
- Safety data handling.
- SAE Reconciliation.
- Handling External Data (Laboratory Data).
- Quality Assurance, Quality Check.
- Database lock / archiving.
- Data transfer.
- Electronic Data Capture.

You can reach us by mailing us at info@meddevices.net