The new integration will support Patient Safety organizations as they define their safety data evaluation strategies
Jersey City, NJ — 8-April-2020 — Prudentia and Feith Systems have entered into a partnership with the integration of MedCodr (by Prudentia) and Orbit (by Feith Systems). MedCodr is Prudentia’s proprietary, standalone, web-based solution for coding medical verbatim terms & products to standard dictionaries, including MedDRA, WHODrug and custom dictionaries (UMC Certified in B3 and C3 Format). Orbit is a validated software platform for end-to-end tracking of GVP activities and deliverables, offering configurable solutions for oversight of Risk Management Plan commitments, Signal Management, Aggregate Safety Reports and more. This partnership better positions both companies in supporting Pharma, Biotech and Medical Device companies during the clinical development and post marketing phases of medicinal products.
Orbit has established itself as the industry standard for managing and tracking global PV Risk Management commitments, especially around Additional Risk Minimization Measures. “Our clients are doing wonderful work to ensure the safety of their patients and are leveraging technology to best manage global commitments. One area all clients continue to invest is artificial intelligence. AI relies on a standard language, and we can now use MedDRA as the unifying terminology between safety concerns on Risk Management Plans and ICSR information. We, along with our clients, will bring the industry a connected dataset ready for smart AI driven insights,” said Dan Feith, President of Feith’s Life Sciences Division, Orbit.
Prudentia is known in the industry as a global provider of information technology, operational consulting, managed services and proprietary software to pharma, biotech and drug safety organizations. “The integration of MedCodr and Orbit is an exciting development for both organizations. Providing an integrated dictionary browser within Orbit allows clients to search for MedDRA terms, other areas of interest (SMQs) and concomitant medications in a much faster, more streamlined and efficient manner, ultimately allowing companies to improve the accuracy and consistency in capturing, retrieving, and evaluating of safety information within Orbit,” said Punit Sinha, Director, Life Sciences Solutions at Prudentia.
About Prudentia
Founded in 2012, Prudentia has organically grown into a global team of Drug Safety professionals, implementing simple solutions to sometimes complex problems. Prudentia provides management and technology consulting services to the pharmaceutical industry, advising companies on processes and technologies in support of clinical and post marketing safety and surveillance. Prudentia implements and upgrades safety databases, provides managed services to maintain safety databases and offers simple turnkey applications bridging gaps in leading safety databases to enhance patient safety.
About Feith Systems
Since 1979, Feith Systems has been creating software and solutions to help organizations manage critical documents, data and business processes. In 2012, Feith started development on Orbit, now known as a leading platform for pharmacovigilance, risk management and Health Authority commitment tracking. Orbit solution provides industry-agreed-upon standard approaches to complex compliance and safety activities with global oversight, local tasking, compliance metrics, and workflows.