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ERT delivers expertise in meeting regulatory requirements
PHILADELPHIA (PRWEB) October 19, 2016
ERT, a leading provider of high-quality patient data collection solutions for use in clinical drug development, today announced its support of the regulatory review of Pediapharm’s Health Canada approval of rupatadine.
ERT conducted the statistical analyses of cardiac safety data collected during the clinical development of rupatadine and developed expert reports that successfully addressed Health Canada’s questions regarding the compound’s safety profile.
“We are proud to have been able to assist Pediapharm on this important study,” said Jim Corrigan, President and CEO, ERT. “We congratulate Pediapharm on their success and look forward to supporting their clinical objectives as they further explore rupatadine’s benefits in bringing relief to patients who suffer from allergy-related symptoms.”
“ERT’s Cardiac Safety experts understand the data, the regulations, and, importantly, what regulators want to see when evaluating a compound’s safety,” said Benoît Hébert, Vice President, Business Development & Licensing, Pediapharm Inc. “The analysis and consulting delivered by their team were extremely critical to this approval.”
Rupatadine (Tablet 10mg and Oral Solution 1mg/mL) was approved by Health Canada for the relief of symptoms associated with Seasonal Allergic Rhinitis (SAR), Perennial Allergic Rhinitis (PAR), and Chronic Spontaneous Urticaria (CSU) in patients 2 years of age and older. It will be available in Canada at the beginning of 2017.
ERT has been influential in supporting biopharmaceutical sponsors, medical device companies, and CROs to improve clinical trial protocols, increase data accuracy, and mitigate risk. The team of in-house industry experts have worked with international regulatory authorities for decades, resulting in a thorough understanding of what methodologies and processes should be employed to ensure quality outcomes.
For more information on ERT’s Cardiac Safety solutions and services, including the centralized collection, interpretation, and distribution of ECG and ambulatory blood pressure data as well as expert scientific and regulatory consulting, visit http://www.ert.com/cardiac-safety.
ERT is a leading provider of high-quality patient data collection solutions for use in clinical drug development. ERT delivers a combination of technology, services and clinical consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process. ERT delivers widely deployed solutions in centralized Cardiac Safety, Respiratory, and electronic Clinical Outcome Assessments (eCOA) – which includes patient-, clinician-, observer- and performance-reported outcomes – and cloud-based analytics and performance metrics. By efficiently integrating these solutions through a system built upon a scientific and regulatory foundation, ERT collects, analyzes and delivers safety and efficacy data critical to the approval, labeling and reimbursement of pharmaceutical products. For more information, see http://www.ert.com. Join ERT on LinkedIn, Twitter, YouTube and Facebook.
For the original version on PRWeb visit: http://www.prweb.com/releases/2016/10/prweb13775059.htmNEXT ARTICLE
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