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Whether you want someone to handle your clinical study in its entirety, assist with specific parts of it or outsource a certain staff, you can choose City as dependable partner. |
EDC
ELECTRONIC DATA CAPTURE (EDC) SERVICES ENSURE FAST, RELIABLE AND COST EFFECTIVE RESULTS FOR OUR CUSTOMERS.
We offer user friendly, 21 CFR Part 11 compliant tools capable of producing data fit for FDA submis- sions. Also, EDC is a cost effective investment that systematically reduces the need for expensive study budgets through a regular stream of studies done on the same platform. With a variety of sup- port programs to choose from, you can choose the one most appropriate to the skillsets of CRAs and investigators at the site.
ADVANTAGES OF EDC SYSTEMS:
- No CRF storage, damage or loss
- Allows for secured data transfer with real-time access to data
- Tracks CRF design with flexibility in layout
- Provides for final sign-off of captured data via e -signature
- Part 21 CFR Part 11 compliant automatic tracking (audit trail) of queries, comments and data changes
- Reduces duplicate queries on multiple CRFs
- Provides for batch loading of lab data and normal ranges
- Provides for reusable data formats
However, there are still numerous studies that are using paper Case Report Forms (CRFs) as in some instances usage of paper CRFs is more time and cost efficient. We offer this to you as well.