FDA Center Chooses New Product Vigilance Software

September 17, 2013

By Bio-IT World Staff 
September 17, 2013 | November Research Group’s PRIMO software platform has been selected as the new product vigilance software solution for the United States Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). The company has been awarded a subcontract through its partner, TKC Global, to provide PRIMO as a replacement for the Center’s MAUDE (Manufacturer and User Facility Device Experiences) system. PRIMO is uniquely designed to meet the needs and challenges of regulatory environments worldwide and November Research Group expects the software to be launched within CDRH by the end of 2013.
Medical device, drug, and biologics companies are required to monitor and report adverse events (AEs) related to their healthcare products. The regulators who oversee these manufacturers have similar legal obligations to ensure the timely and thorough review of these reports to monitor overall public health and product safety. To best address the need for accuracy and efficiency, these groups rely on sophisticated software solutions such as November Research Group’s PRIMO software platform. PRIMO is a unique web-based solution designed specifically to streamline the intake, review and triage of adverse event reports within the healthcare industry.
“With years of experience working within this unique segment of the healthcare industry, we clearly understand the needs and challenges faced by medical product companies and regulators. It was with that level of understanding that we created PRIMO,” said Seth Warhaftig, president of November Research Group in a statement. “We look forward to working with CDRH and supporting their commitment to product vigilance and public health.”
PRIMO’s open architecture allows regulatory authority users to capture, organize, and review a high volume of adverse event reports from a variety of electronic sources. The high throughput review capability is critical for regulatory groups such as CDRH that receive more than 1,000 reports each day and must quickly determine an appropriate course of action for each report. Additionally, PRIMO offers an “intelligent” report review function and powerful correspondence tracking to support regulatory authority users in their decision-making and case management processes. The result is a rich user experience that drives efficiencies and assists in achieving the patient safety goals that underpin all product vigilance activities.
Different from commercially available pharmacovigilance solutions that are primarily focused on generating the reports that are sent to regulators, PRIMO is specifically designed for streamlined report intake and high-volume, intelligent report review. This distinction positions PRIMO as the superior solution for regulatory authority use.