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Instantaneous, robust data edit checks and validations are integrated into the data entry process, streamlining data capture while maintaining data integrity. Clinically meaningful analysis-ready data are delivered in real-time.

Our standard data checks include complex conditional range checks: (e.g., age and gender-specific normal ranges for lab tests) and complex logic checks:(e.g., if type 1 diabetes was reported, insulin treatment must be reported). In addition, we check for spurious data in serially measured parameters: e.g., if DBP (measured at weekly interval) is reported as 67, 72, 62, 85, 69 mmHg, the 85 mmHg point will could be flagged as possible error.

Typically, in traditional clinical studies, more than 80% of the data errors are date-related, therefore we place heavy emphasis on checking the validity of date reported (visit dates, test and re-test dates, medication and adverse event dates, etc.) against key reference dates, such as date of informed consent, baseline visit, randomization, crossover, termination (treatment and study), etc.

In "Active Managed" edcpro trials, the system is configured to prohibit reporting of future dates, or completion of a visit/module beyond the current visit.

The depth of our on-line data validation (in combination with our unique workflow) enables us to "guarantee" analysis-ready data to be readiliy available.

 

Sept 21, 2005
White Paper on edcpro 2.00 available upon request more>>

Thursday, Nov 3, 2005
edcpro Webinar to launch release of v3.00. Please contact us to register.
more>>
Spring 2006
2-day Seminar on novel trial design for biotech - includes demo of edcpro 3.00 more>>
 

 


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