Prosoft Clinical is a Consulting and Clinical Research Organization that has been providing product development and analysis services to the pharmaceutical, biotech and medical device industries since 1995. We support our clients with both a rapid turnaround of each clinical study and with long-term support of all aspects of a product development program, supported by our years of experience from the early product concept phase through studies conducted following marketing approval. We retain exceptional clinical research and product development professionals on a long-term basis, with both CRO and sponsor experience, for all of your program needs. We specialize in providing clinical, statistical and regulatory solutions to fit within your development programs, spanning all phases of clinical study conduct for your pharmaceutical ANDA, 505(b)(2) and NDA applications as well as your 510(k) and PMA medical device programs. • Biostatistics - Our Clinical Biostatisticians and Programmers bring comprehensive biomedical expertise specifically tailored to your unique study. Direct study design and detailed process organization are the foundation of our approach to all programs. • Clinical Operations – The Prosoft Clinical world class Clinical Operations team has years of experience gained across all trial stages and broad therapeutic areas. We bring urgency and efficiency to every study. • Data Management – We bring CRF design to our EDC system, specifically designed with your study design and rapid data analyses in mind. • Consultative Services - With an average of 20 to 30 years of experience from both the CRO and sponsor environments, the Prosoft Clinical consulting staff brings both the detailed and the ‘big picture’ approach to all phases of your product development programs.