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DIGITAL ECG SUBMISSIONS ALREADY A COVANCE STANDARD
Covance Central Diagnostics is Prepared to Support the FDA's New Proposed Standardized Digital Data Format Initiative Today |
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Reno, Nevada, 17 December 2001 — Covance Inc. (NYSE: CVD) through their Central Diagnostic facility in Reno, Nevada, has processed ECGs in a digital environment for nearly 30 years. Covance is the only Central ECG supplier whose current services will be adaptable to any direction that the Food and Drug Administration (FDA) is expected to adopt for standardization of digital ECG data formats. Covance is uniquely positioned to assist customers in applying the proposed submission standards discussed at the recent Electronic Interchange Standard for Digital ECG and Similar Data Public Meeting with the FDA on 19 November 2001 if and when they become mandatory. At Covance, this is not accomplished by converting a paper waveform into a digital data readout, but by acquiring the original ECG signal electronically.
Covance Central Diagnostics recognizes that preparing for changes in FDA guidance can be an arduous task for pharmaceutical companies. Therefore, Dr. Daniel Goodman, the Director of Medical Affairs and Scientific Innovation, and Dr. Douglas Ramseth, the Director of Medical Engineering for Covance Central Diagnostics, were presenters at the recent 19 November meeting with the FDA. The meeting focused on the implications of the proposed FDA guidance to pharmaceutical companies. The following key messages were presented on the direction of the FDA in this matter:
- The final standard has not been established but is expected to occur prior to the next Public Meeting scheduled for 1 April 2002.
- The implementation of the new guidance is expected to start 1 May 2002.
- All NDA submissions are expected to be compliant by Fall 2002. After implementation, speakers stated that submissions will be turned back if they aren't accompanied by digital ECG files.
- Scanning paper ECGs into an electronic system is viewed negatively — the original digital signal is preferred.
- Electronic storage/archiving of the ECGs does not need to occur at investigator sites. It can be done by a "trusted 3rd party" such as a core ECG lab.
At Central Diagnostics, the original ECG signal is electronically acquired through the use of the proprietary MTX-2, 12-lead system. Once the signal is received, Central Diagnostics verifies the quality of the signal in real-time, then all ECG data are reviewed by Board-certified cardiologists who provide consistent interpretations.
"We are confident that the meeting on November 19th confirmed what we already knew and have already been delivering for years," said Eileen Daniel, Vice President and General Manager of Covance Central Diagnostics. "We can readily apply the proposed standards as presented at the meeting to existing data so that our clients can comply with the new NDA submission standards when they become mandatory. Central Diagnostics has provided electronic archiving services for more than 351 trials over the past 9 years."
Covance is uniquely positioned to assist customers in preparing for the new FDA guidance in standardized digital ECG data and with all of its related service offerings for the drug development industry. Covance is encouraging all customers to explore their anticipated need for centralized ECG services to verify that they will be in compliance once the FDA has established the new standards for digital ECG data. An educational e-Conference, which provided an in-depth and detailed overview of the new proposed regulations and their impact on the drug development process, was presented by Covance on 29 November 2001. If you are interested in finding out more about the proposed changes, you can review the presentation in the Covance on-line MedForum. You will need to register for the e-Conference series in order to access the MedForum site. To register go to www.covance.com/econference/, complete the registration form, and a password will be instantly issued for you to gain access to the MedForum site.
You can also contact a digital ECG specialist at Covance Central Diagnostics at 1-888-COVANCE.
Covance, with headquarters in Princeton, New Jersey, is one of the world's largest and most comprehensive drug development services companies with 2000 pro forma revenues of $737 million, operations currently in 17 countries, and approximately 7,200 employees worldwide. Information on Covance's products and services, recent press releases, and SEC filings can be obtained through the website in the About Covance area. |
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