Prosoft Clinical is a privately held contract research organisation headquartered in Chesterbrook, Pennsylvania, United States. Operating since 1995, it supports clients both through rapid turnaround of individual clinical studies and through long-term support of complete product development programmes, from the early product concept phase through to post-marketing studies.

The company’s operating model is built around internal technology and long-tenured staff. It runs its own electronic data capture (EDC) system and its own IP management and interactive web response (IWR) systems, and states that its data management, biostatistics, clinical operations, medical, quality, and regulatory teams operate without reliance on outside vendors. Its professionals bring experience from both CRO and sponsor environments, and its consulting staff average 20 to 30 years of experience. Sponsors have described the team as performing like an extension of their own organisation, including taking on projects that other CROs had not delivered, and as avoiding the routine change orders that some CROs apply.

Prosoft Clinical provides individualised clinical, statistical, and regulatory solutions across all phases of development, including pharmaceutical ANDA, 505(b)(2), and NDA applications and medical device 510(k) and PMA programmes.

Key Products and Services

Clinical Operations

• Clinical trial management across all trial stages and a broad range of therapeutic areas
• Rescue support for studies placed with other organisations

Data Management and Technology

• Data management solutions, with CRF design built into the company’s own EDC system, designed for rapid data analysis
• eDC — proprietary electronic data capture system
• eNroll — proprietary enrolment and IP management / IWR system
• CDISC standards support for submission-ready datasets

Biostatistics

• Clinical biostatisticians and programmers providing study design, statistical analysis, and reporting tailored to each study

AdaptIQ™ Adaptive Study Design

• Adaptive design platform using machine learning and predictive modelling, particularly for Phase I–II studies
• Real-time trial monitoring and projection of trial outcomes as data accumulate, supporting informed mid-study decisions to reduce the risk of failure and lower timelines and cost

Medical Writing

• Clinical and regulatory documents for development programmes

Regulatory Operations

• Regulatory submission preparation and management for ANDA, 505(b)(2), NDA, 510(k), and PMA pathways

CMC Development

• Chemistry, manufacturing, and controls development support for pharmaceutical programmes

Consultative Services

• Senior consulting across all phases of product development, drawing on combined CRO and sponsor experience

Prosoft Clinical occupies the boutique full-service CRO segment, serving sponsors that value continuity of senior staff, flexible engagement, and in-house technology over the scale of larger global CROs. Its ownership of EDC, IWR, and enrolment systems keeps key study technology under one roof, which supports speed and cost control. Its pairing of 505(b)(2), ANDA, NDA, 510(k), and PMA experience positions it for both specialty pharmaceutical and medical device sponsors working through US regulatory pathways. The AdaptIQ platform adds a data-driven design capability aimed at early-phase programmes, where cost and failure risk are highest. Its clients can use it for full-service programmes or for partial support, depending on project needs.