Prosoft Clinical Email Format
Biotechnology ResearchPennsylvania, United States11-50 Employees
Prosoft Clinical is a biotechnology research organization that acts as both a consulting firm and a clinical research organization. It provides clinical, statistical, and regulatory services to pharmaceutical, biotech, and medical device developers, supporting programs from early concept through post-approval studies and across multiple regulatory pathways, including ANDA, 505(b)(2), NDA, 510(k), and PMA. The company emphasizes delivering rapid study turnarounds alongside long-term program support, drawing on a staff with CRO and sponsor experience to manage all phases of product development. Based in the Chesterbrook area of Pennsylvania, Prosoft Clinical has established a cross-functional team spanning biostatistics, clinical operations, data management, and consultative services to tailor development programs to client needs. The organization positions itself as maintaining experienced professionals on a long-term basis to support ongoing product development efforts and program continuity. A recent development noted is a partnership announced in 2025 with Advanced Medical Services GmbH to integrate systems with Prosoft Clinical’s electronic data capture platform, aimed at improving trial execution.