April 15, 2008
VIBGYOR provides annotated ECG datasets that conform to the HL7 standard.
VIBGYOR Scientific Research Pvt. Ltd., India – February 3, 2008: VIBGYOR provides ECG corelab service to analyze digitized ECGs to prove Cardiac Safety of the drug as per regulatory guidelines. The regulatory guideline states that “The drugs should receive an electrocardiographic (ECG) evaluation beginning early in clinical development, typically including a single trial dedicated to evaluating their effect on cardiac repolarization. Failure to perform adequate non-clinical and clinical assessments (of standard ECG intervals and waveforms) of a drug can be justification to delay or deny marketing authorization.”
VIBGYOR announces the achievement of Mortara Certified Partnership status. This program serves central laboratories and provides expert consultation and validation of HL7 annotated ECG toolsets that generate records to be uploaded to the E-Scribe ECG Warehouse. Working with Mortara Certified Partners, sponsors can be assured of receiving annotated ECG datasets that conform to the HL7 standard that will be smoothly imported into the E-Scribe ECG Warehouse. Mortara software systems provide annotated data sets that conform to the HL7 standard and can be seamlessly imported into the E-Scribe ECG Warehouse with NDA submission.
VIBGYOR ExcelCore – ECG corelab was established in June, 2007. The director of VIBGYOR ExcelCore - Dr. Ajay Naik, is the leading Cardiac Electrophysiologist of India, trained at Cedars - Sinai Medical Centre; Los Angeles, U.S.A. VIBGYOR ExcelCore operates in collaboration with the Care Cardiovascular Consultants Pvt. Ltd., the largest cardiology group practice in India. VIBGYOR ExcelCore works with adherence to the U.S. Food and Drug Administration (USFDA) and the International Conference on Harmonization (ICH) guidelines.
Vibgyor offers comprehensive spectrum of research services in clinical studies to streamline the development process of global pharmaceutical and device companies. Our goal is to provide exceptional services with a commitment to produce quality data in the given time frame and budget. We have conducted several clinical trials with outstanding quality. Our therapeutic areas of interest include cardiology, oncology, nephrology, and infectious diseases. Please refer to www.vibgyorcare.com
for more information.
Mortara Instrument headquarters are located in Milwaukee, Wis., with European operations based in Bologna, Italy. Mortara is distinguished in the field of non-invasive cardiology innovations that are the core of its complete line of ECG products including electrocardiographs, stress exercise systems, Holter systems, data warehousing solutions, and cardiology monitoring systems. The company website is www.mortara.com