Prosoft Clinical is a full service Clinical Research Organization that has also 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. Our internal electronic data capture and IP management / IWR systems, combined with our data management, biostatistical, clinical operations, medical. quality and regulatory teams are free of reliance on outside vendors and provide peak efficiency and cost effectiveness.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 routinely provide individualized clinical, statistical and regulatory solutions to fit within your unique programs, spanning all phases of product development for your pharmaceutical ANDA, 505(b)(2) and NDA applications as well as your 510(k) and PMA medical device programs.