Jennifer Feldmann Email & Phone Number

Expert knowledge and implementation experience in CDISC SEND and Define-XML standards, as well as FDA requirements for submission of electronic nonclinical data. Active roles with CDISC SEND and Define-XML standards development teams, and PhUSE nonclinical data standards implementation teams.25 years experience in all aspects of software design, service, sales, marketing and management for products supporting preclinical safety assessment studies conducted by pharmaceutical companies and contract research laboratories. An additional 10 years programming experience for laboratory systems. Exceptional business analysis, product design, software quality, system deployment, and small business management skills. Thorough knowledge of the drug development process and associated regulations.Current Focus:Nonclinical study submission package review (SEND, Define.XML, nSDRG)Training and consulting services on Define-XML implementation for SENDSpecialties: Preclinical drug safety information systems analysis, design and deploymentCDISC SEND (Standard for Exchange of Nonclinical Data) and Define-xmlTechnical software sales and business developmentSoftware product design and managementComputer system validation

Listed skills include Cdisc Send, Nonclinical Data And Data Management, and Software Design.