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Innovative ECG monitoring and reporting can save time and money in early drug development
RALEIGH, N.C., Oct. 1, 2015 – INC Research Holdings, Inc. (Nasdaq: INCR), a leading, global Phase I to IV contract research organization, today announced it is certified to use the iCardiac Early Precision QT approach for evaluating the cardiac safety of new compounds in Phase I clinical development. INC’s use of iCardiac Early Precision QT may help customers reduce costs, and increase the accuracy, reliability and speed of cardiac safety testing in clinical research.
“INC Research continually seeks innovations that enhance the full drug development lifecycle,” said Jamie Macdonald, Chief Executive Officer. “Achieving certification to conduct trials using iCardiac Early Precision QT is a prime example of the Company’s focus on driving efficiency for customers through new approaches. As drug development becomes increasingly complex and the amount of data captured, stored and applied multiplies exponentially, this approach has the potential for significant time and cost savings for customers.”
Since 2005, the FDA has required all new compounds under development to be tested to determine their impact on the QT interval – the time between the start of the Q wave and the end of the T wave during the heart’s electrical cycle. A lengthened QT interval indicates potential safety risk factors for a new drug.
With this technology in place, INC may be able to eliminate the need for a separate, dedicated Thorough QT (TQT) study, which can cost between $2 million and $5 million. By applying this innovative approach, INC can help companies spend only a fraction of that amount and collect cardiac safety data during Phase I trials rather than during later stage trials. By making cardiac safety assessments earlier in clinical development, researchers may be able to speed the development process, help to avoid promising drugs being inappropriately eliminated through inaccurate cardiac data, bring new therapies to market sooner, better allocate resources and reduce spending. As a certified user of iCardiac Early Precision QT, INC will help customers find ways to take advantage of this innovative approach to cardiac safety.
INC offers a broad range of Early Phase study services, including: strategic consulting for study design, data analysis and reporting; regulatory and ethics boards submissions; clinical study conduct including project management; medical and scientific writing; protocols; clinical study reports; data management and statistical analyses. Studies experience includes: first-in-human SAD and MAD; bioavailability/bioequivalence; skin irritation and sensitization; PK/PD and pharmacogenomics; human abuse potential; and drug, alcohol and food interaction.
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include, but are not limited to: our customer or therapeutic area concentration; failure to perform our services in accordance with contractual requirements, regulatory standards and ethical considerations; the impact of a failure to retain qualified management and key personnel; the impact of changes in government regulations and healthcare reform; and the other risk factors set forth in our Form 10-K for the year ended December 31, 2014, our Form 10-Q for the quarter ended March 31, 2015, and other SEC filings, copies of which are available free of charge on our website at investor.incresearch.com. INC Research assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
About INC Research
INC Research (Nasdaq: INCR) is a leading global contract research organization (CRO) providing the full range of Phase I to Phase IV clinical development services for the biopharmaceutical and medical device industry. Leveraging the breadth of our service offerings and the depth of our therapeutic expertise across multiple patient populations, INC Research connects customers, clinical research sites and patients to accelerate the delivery of new medicines to market. The Company was ranked “Top CRO to Work With” among large global CROs in the 2015 CenterWatch Global Investigative Site Relationship Survey. INC Research is headquartered in Raleigh, N.C., with operations across six continents and experience spanning more than 100 countries. For more information, please visit www.incresearch.com.