Industry Leaders Share Expertise through Complimentary White Paper on ePRO Regulatory Inspections
ERT, a global solutions provider for high-quality patient safety and efficacy endpoint data collection, today announced it has reached a significant milestone in capturing important data to support the approval of new medical products. To date, global regulatory agencies have issued over 300 approvals to biopharmaceutical companies that relied on ERT’s cardiac safety, respiratory, or eCOA solutions to capture critical safety and/or efficacy data in their clinical programs.
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/.