Prosoft Clinical

What Prosoft Clinical does

Prosoft Clinical is a privately held, full-service Contract Research Organization (CRO) founded in 1995 and headquartered in Chesterbrook, Pennsylvania. The firm delivers clinical development services — clinical operations, data management, biostatistics, medical writing, regulatory operations (ANDA, 505(b)(2), NDA, 510(k), and PMA submissions), CMC development, and consultative services — to pharmaceutical, biotechnology, and medical device sponsors across all phases of product development from concept through post-marketing. The company also operates a secondary facility in Wayne, Pennsylvania.

The firm's differentiator is its stack of proprietary, in-house technology platforms: eDC, a web-based electronic data capture system with CFR 21 Part 11 compliance and integrated IWRS connectivity; eNroll, a proprietary interactive web response system (IWRS) for randomization, enrollment tracking, and investigational product supply management; and AdaptIQ™, an adaptive study design methodology. These systems are operated without third-party vendor dependency, enabling integrated data flows across CRF design, randomization, and statistical analysis. The technical capability is reinforced by documented regulatory compliance (successful 2017 FDA audit with no Form 483), CDISC Tabulate certification, and a senior consulting bench averaging 20-30 years of CRO and sponsor experience under President and Chairman Dror Rom, Ph.D.

Prosoft operates on a project-based professional services revenue model, acquiring clients through a formal Request for Proposal (RFP) process targeting enterprise sponsors in pharma, biotech, and medical device. The company has remained a privately held boutique since founding. In October 2025, Prosoft signed a definitive agreement with AMS Advanced Medical Services to form a global full-service CRO; AMS made a significant initial investment via its US subsidiary, with Prosoft leading combined North American operations while AMS retains European and UK presence.

Name

Prosoft Clinical

Legal name

Prosoft Clinical

Website

https://prosoftclinical.com

Company type

Private

Founded year

1995

Operating status

Operating

Headcount range

11–50 employees

Short description

Prosoft Clinical is a privately held, full-service Contract Research Organization founded in 1995, providing clinical operations, biostatistics, regulatory, and data management services to pharmaceutical, biotech, and medical device sponsors, supported by proprietary eDC, eNroll IWRS, and AdaptIQ adaptive design platforms.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (54171), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG)

Keywords

• Clinical research services
• Pharmaceutical development
• Medical device trials
• Clinical data management
• Regulatory submissions

Headquarters

HQ city

Wayne

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Others

Revenue model

1. Clinical Research Services: Full-service CRO providing comprehensive clinical development services including clinical operations, data management, biostatistics, medical writing, regulatory operations, and CMC development. Services are project-based and span all phases of product development for pharmaceutical ANDA, 505(b)(2), NDA applications and medical device 510(k) and PMA programs.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels3 records

Core offering

Prosoft Clinical is a full-service Contract Research Organization (CRO) that has provided product development and analysis services to the pharmaceutical, biotech, and medical device industries since 1995. The company delivers clinical operations, data management, biostatistics, medical writing, regulatory operations, and CMC development services across the entire product lifecycle — from early concept through post-marketing studies — supporting ANDA, 505(b)(2), and NDA drug applications as well as 510(k) and PMA device programs. Its in-house eDC and eNroll technology platforms are free of reliance on outside vendors, providing the operational backbone for the firm's clinical research services.

Product overview

Prosoft Clinical offers a unified full-service CRO platform combining proprietary technology products with comprehensive clinical research services. The core technology portfolio includes AdaptIQ™ (adaptive study design), eNroll (interactive web response system for randomization and IP management), and eDC (web-based electronic data capture). These technology products are complemented by service offerings spanning Clinical Operations, Data Management, CDISC, Biostatistics, Medical Writing, Regulatory Operations, CMC Development, and Consultative Services. The company supports the full product development lifecycle from early concept through post-marketing for pharmaceutical ANDA, 505(b)(2), NDA applications and medical device 510(k) and PMA programs.

Differentiator

Problem solved

Functional benefit

Brands

• eDC: Prosoft's electronic data capture system - a cutting-edge web-based platform that manages clinical studies efficiently with real-time reports, auto-coding, edit checks, IWRS integration, 24/7 global availability, and CFR 21 Part 11 compliance.
• eNroll

Products and services

• Clinical Operations Full-service clinical trial management covering all trial stages and broad therapeutic areas, delivered by a team with experience across CRO and sponsor environments. Service is built around urgency and efficiency in study execution for pharmaceutical, biotech, and medical device sponsors.
• Data Management Solutions CRF design integrated with Prosoft's EDC system, specifically designed for study design and rapid data analyses for clinical trial sponsors.
• CDISC CDISC data standards implementation and certification services for regulatory submissions, with double programming validation prior to release of final project deliverables.
• Biostatistics Clinical biostatistics and programming services applying comprehensive biomedical expertise specifically tailored to unique study designs, with direct study design input and detailed process organization.
• Medical Writing Medical writing services for protocols, clinical study reports, and regulatory documentation for pharmaceutical, biotech, and medical device sponsors.
• Regulatory Operations Regulatory affairs support for ANDA, 505(b)(2), NDA, 510(k), and PMA submissions across drug and medical device programs.
• CMC Development Chemistry, Manufacturing, and Controls (CMC) development services supporting pharmaceutical product development and regulatory filings.
• Consultative Services Strategic consulting delivered by Prosoft staff averaging 20-30 years of experience from both CRO and sponsor environments, providing detailed and big-picture support across all phases of product development programs.
• eDC Proprietary web-based Electronic Data Capture platform that manages clinical studies efficiently with real-time reports and metrics, auto-coding, edit checks, IWRS integration, 24/7 global availability, advanced security, and 21 CFR Part 11 compliance. Available with complete in-house data management services or licensing programs for clinical study sponsors.
• eNroll Proprietary Interactive Web Response System (IWRS) that allows study directors to electronically enter and randomize study subjects, handle drug supply management, track enrollment, and provide inventory and reconciliation reports. Supports multiple randomization designs with automated triggers, email/fax requests, alerts, and integrated database with the eDC platform.
• AdaptIQ™ - Adaptive Study Design Adaptive Study Design solution that enables flexible trial designs with pre-specified adaptation rules for pharmaceutical and medical device clinical programs.

Quantifiable outcome

• Successful FDA inspection with no critical findings and no Form 483 issued

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• AMS Advanced Medical ServicescoreStrategic or Co-development Partner · 1 October 2025Prosoft Clinical and AMS Advanced Medical Services signed a definitive agreement in October 2025 to join forces and create a truly global, full-service CRO. AMS, via its US subsidiary, will make a significant initial investment in Prosoft, with additional investments planned as the companies move toward full integration. Prosoft will lead all North American Operations while AMS will continue to expand its established presence across Europe and the UK. The combined organization will leverage capabilities in biostatistics, data management, clinical operations, Health Technology Assessment (HTA), and advanced technology.

Scale indicators3 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• Medpace: Mid-sized, science-focused full-service clinical CRO with strong biostatistics, regulatory, and medical device capabilities; directly comparable to Prosoft in service mix and operating model, though materially larger in scale.
• Worldwide Clinical Trials: Mid-sized, scientifically-led CRO offering clinical operations, biostatistics, and regulatory services across multiple therapeutic areas; closely mirrors Prosoft's boutique, science-driven positioning.
• Premier Research: Specialty CRO providing clinical development, regulatory, and biostatistics services to pharma and medical device sponsors; comparable in size and service breadth to Prosoft.
• Rho: Full-service CRO with strong biostatistics, data management, and regulatory submission expertise supporting pharma and device sponsors; closely comparable to Prosoft's core service portfolio.
• Synteract: Mid-sized CRO offering clinical operations, biometrics, and regulatory services across therapeutic areas; similar in scale and full-service positioning to Prosoft.
• Cytel: Biostatistics- and data-science-focused CRO supporting clinical trial design, adaptive studies, and regulatory submissions; directly comparable to Prosoft's biostatistics and AdaptIQ offerings.

Broad incumbents

• IQVIA: Largest global full-service CRO with extensive technology, data, and site-network capabilities; sets the competitive benchmark for scale, reach, and integrated trial delivery versus boutique CROs like Prosoft.
• ICON plc: Global full-service CRO formed via the PRA Health Sciences merger, offering end-to-end clinical development across pharma and medical device; represents the Tier-1 competitor against which Prosoft must differentiate.
• Labcorp Drug Development (formerly Covance): Global CRO with integrated central laboratory, clinical development, and regulatory services; broad incumbent competing across the same pharma and device sponsor RFPs that Prosoft targets.
• Parexel: Large global CRO (taken private by EQT and Goldman Sachs) offering comprehensive clinical development, biostatistics, and regulatory services; serves as a major incumbent competitor across Prosoft's therapeutic and device programs.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/ProsoftClinical
• LinkedInlinkedin.com/company/prosoft-clinical

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Prosoft Clinical