ORCA supports both paper-based and electronic data capture (EDC) data collection systems. To that end, ORCA can provide “best in class” platforms with proven (21 CFR Part 11-compliant) data management systems.
| In this environment, data which originates from the patient's chart is transcribed onto a paper Case Report Form (CRFs). The CRFs are used to enter the data into an auditable database which is required to ensure regulatory compliance. The database can be audited against the paper CRFs for accuracy. The advantage of this system is that it allows for both paper and electronic databases to be maintained
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| In this environment data which originates from the patient's chart is entered directly into a highly redundant and auditable database. This database is designed to ensure regulatory compliance and future data availability. The EDC system can be audited against the data in the patient charts for accuracy. The advantage of this system is that it allows for real-time data review as well as being less labor intensive.
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