iEDC technology
iEDC, the next generation EDC (Electronic Data Capture) technology can provide high quality clinical databases with error rates between 0.01% - 0.1%. Initial error rate is typically around 0.1% which is already FDA acceptable quality and is much lower than the final error rates for EDC technologies. Cost is also exceptionally low mainly because there are no edit checks to be progrmmed and there are no expensive queries to be resolved. The automated navigator makes it a fast operation shrinking the total processing time cycles by months after LPLV.
THE TECHNOLOGICAL EFFICIENCIES OF BANKS AND RETAIL STORES ARE UPON US*.
Key Benefits
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Hi Quality Clinical Databases
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Exceptional low cost
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Remarkable short processing times after LPLV.
iEDC technology has substantive advantages over the traditional EDC technologies. Among these advantages are:
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reduces the complexity of the system as a major error source
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Provides earlier access to clean data
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Reduces the error rate
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Captures protocol intent. Can effectively run large complex trials.
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Reduces study start time to 2 weeks (typical EDC start times 8 - 12 weeks)
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No Edit Checks programming
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Improves clinical site satisfaction
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Reduces site training
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Reduces trial time
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Reduces dm processing time due to now query resolution required
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Interface simplicity - duplication of CRF
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Electronic monitoring reduces monitoring time and effort
*US Patent and Trademark Office August 22, 2005
Like Lubin, Martorelli has grown weary of trying to predict when pharma will adopt the efficiencies of banks or retail stores. “We were way too optimistic on what this adoption cycle would look like” Martorelli said.
IDC technology has been used by one of the major pharmaceutical companies for 10 years in hundreds of clinical trials phase I - phase V. During this period the average NDA approval time for this company was 10 - 12 months while the pharmaceutical industry's average NDA approval time was 30 months. Clinical databases were delivered to the FDA with error rates ranging between 0.01% - 0.1% and passed all rigorous audits by the FDA.
