Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
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News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
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In order to receive regulatory approval of new medical treatments, biopharmaceutical companies must first demonstrate the product’s safety and efficacy through a series of controlled clinical trials. ERT’s suite of products and services for cardiac safety, respiratory, and eCOA – which include electronic patient reported outcomes (ePRO) – are repeatedly relied upon for capturing these important data.
“It is extremely rewarding to realize that so many biopharmaceutical companies have brought new medical treatments to market using products and services delivered by ERT,” said Jeffrey Litwin, M.D., CEO of ERT. “We are committed to delivering innovative and reliable solutions that meet the needs of our worldwide customers and supporting their efforts to bring life-enhancing and life-saving medical products to patients who need them.”
ERT is sharing its knowledge of supporting regulatory approvals by offering a complimentary white paper entitled “ePRO Regulatory Inspections: Best Practices for Smooth and Successful Outcomes.” This paper reviews ERT’s experiences in supporting and participating in ePRO regulatory inspections by the U.S. FDA, European Medicines Agency (EMA), specifically BfArM (German Federal Institute for Drugs and Medical Devices), and the Japanese Pharmaceutical and Medical Devices Agency (PMDA), and outlines best practices for minimizing risk in preparation for regulatory inspections of ePRO data collection systems. The paper is available for complimentary download at www.ert.com/clinical/resources/white-papers/.
For additional information on ERT’s proven cardiac safety, respiratory, and eCOA products and services, visit www.ert.com/clinical/clinical-endpoints/.