– Clinilabs, Inc., a specialty contract research organization (CRO), is now a Mortara Certified Partner capable of collecting, processing, and transmitting annotated ECG data compliant with ECG Warehouse requirements. The Clinilabs ECG Core Laboratory and integrated cardiac safety unit provide state-of-the-art facilities in support of ECG intensive and thorough QT (TQT) studies, operating to the standard required for upload of datasets into the FDA’s ECG Warehouse.
With Mortara Certified Partner status, Clinilabs has a competitive advantage in serving sponsors, and is now among the world’s leading vendors of ECG services. Sponsors that choose Clinilabs as their ECG Core Lab are assured of exceptional service and minimal risk of study failure.
“As a Mortara-certified ECG Core Laboratory, Clinilabs is poised to provide sponsors with the same world-class quality in ECG data management that both large pharmaceutical and biotechnology companies have grown accustomed to receiving from us as a core lab in the CNS arena since 2002,” stated Dr. Gary Zammit, Clinilabs’ President and CEO.
Developed in association with the FDA, the Mortara ECG Warehouse offers tools for uploading annotated ECGs with the Agency capable of efficient review, scoring, and warehousing.
Clinilabs is a specialty contract research organization (CRO) that provides a full portfolio of services to pharmaceutical, biotechnology, and medical device companies involved in the development of central nervous system (CNS) and cardiovascular (CV) therapeutics. The Company also provides early phase services in a wider range of therapeutic areas at its Phase I facility. Established in 2001, Clinilabs has provided services to more than one third of the world’s top 20 pharmaceutical companies, and has been involved in 7 successful New Drug Applications (NDAs) in central nervous system (CNS) and cardiovascular (CV) indications. For more information, please visit www.clinilabs.com.
Mortara Instrument, Inc, based in Milwaukee, WI, is distinguished in the field of non-invasive cardiology for innovations that are the core of the company’s complete line of ECG products including electrocardiographs, stress exercise systems, Holter systems and data warehousing solutions, and cardiology monitoring systems. The Company’s website is www.mortara.com.
Jeanine M. Estrada
212-981-2716
jestrada@clinilabs.com
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