What Clinical Outcomes Solutions does

Clinical Outcomes Solutions (COS) is a global clinical outcomes consultancy founded in 2013 and headquartered across Tucson, Arizona (US) and Folkestone, Kent (UK). The company specializes in Clinical Outcome Assessment (COA) research for pharmaceutical and biotechnology sponsors, operating through specialized Business Units (Quantitative Science, Qualitative Science, Prospective Studies, Evidence Synthesis, Research Operations) supported by Technical Support Units. Service offerings span the drug development continuum, including COA measurement strategy and regulatory support, COA planning and execution, data collection and analysis, psychometric planning and analytics, and interpretation and communication for regulatory submissions. The company emphasizes patient-centered outcomes and active thought leadership through scientific publications and participation in industry forums such as ISOQOL, ISPOR, and ASCO.

The company's core technology asset is COAScape-AI, a patented proprietary AI-powered platform that uses purpose-built Biomedical LLMs to automate evidence synthesis for COA landscape reviews. The platform performs abstract screening, full-text extraction, ontology-driven semantic concept mapping, and automated conceptual model development, with claimed throughput of 1,000+ citations processed per hour and up to 95.5% agreement rate with expert review. COS monetizes through project-based professional services engagements with pharma and biotech sponsors plus flexible subscription licensing for the COAScape-AI software, ranging from individual users to enterprise teams. The company sells via direct enterprise engagement, thought leadership marketing, scientific publications, conference presence, and webinars, and was acquired in 2024 by Validant, a data-focused consultancy.

Name

Clinical Outcomes Solutions

Legal name

Clinical Outcomes Solutions LLC

Website

https://clinoutsolutions.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

11–50 employees

Short description

Clinical Outcomes Solutions is a global COA research consultancy serving pharmaceutical and biotechnology sponsors with regulatory-grade patient-centered outcome assessment services and the COAScape-AI platform for AI-driven literature synthesis.

Ownership category

akta.pro rank

Product category

Clinical Outcomes Assessment Consulting

NAICS

Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (541690)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Management Consulting Services (8742)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industry

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

Keywords

• Clinical outcomes research
• Patient-reported outcomes
• COA consulting services
• Clinical outcome assessments
• Evidence synthesis research

Headquarters

HQ city

Tucson

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, Infrastructure

Revenue model

1. Clinical Outcomes Research Consulting Services: COS provides comprehensive consulting services across all facets of COA research including strategic consulting, COA planning and execution, data collection and analysis, and interpretation and communication. Revenue is generated through project-based professional services engagements with pharmaceutical and biotechnology sponsors.
2. COAScape AI Software Licensing: The company offers flexible licensing for COAScape AI platform ranging from individual users to enterprise teams, supporting faster literature review and structured COA insight generation.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

Clinical Outcomes Solutions (COS) is a global clinical outcomes consultancy providing end-to-end Clinical Outcome Assessment (COA) research services for pharmaceutical and biotechnology sponsors, spanning strategic consulting, COA planning and execution, validated data collection and analysis, and interpretation/communication for regulatory submissions. The firm operates through specialized business units (Quantitative Science, Qualitative Science, Prospective Studies, Evidence Synthesis, Research Operations) and complements its consulting practice with COAScape-AI, a patented AI-powered platform that automates COA literature reviews and evidence synthesis using purpose-built biomedical LLMs.

Product overview

Clinical Outcomes Solutions (COS) is a global clinical outcomes consultancy offering a platform of research services and an AI-powered software product (COAScape-AI) for COA research. The core offering consists of strategic consulting services across the drug development continuum, including COA Planning & Execution, Data Collection & Analysis, and Interpretation & Communication. These services are delivered through specialized Business Units (Quantitative Science, Qualitative Science, Prospective Studies, Evidence Synthesis, Research Operations) supported by Technical Support Units. COAScape-AI is the company's primary software product, an AI-powered platform for streamlining COA landscape reviews and literature synthesis.

Differentiator

Problem solved

Functional benefit

Brands

• COAScape-AI: AI-powered platform for streamlining COA landscape reviews, literature synthesis, and evidence generation - transforms literature into decision-ready COA evidence

Products and services

• COAScape-AI Patented proprietary AI platform that transforms clinical and scientific literature into decision-ready Clinical Outcome Assessment (COA) evidence. Features purpose-built Biomedical LLMs for abstract screening, full-text extraction, ontology-driven semantic concept mapping, automated concept tabulation, and conceptual model generation. Offered via flexible licensing to individual users and enterprise teams.
• Strategic Services & Consulting Strategic COA consulting engagement providing deep industry knowledge and industry-leading researchers to ensure regulatory compliance and optimized patient-centric outcomes for pharmaceutical and biotech sponsors.
• COA Planning & Execution End-to-end research planning and trial management service for COA-focused clinical studies, designing well-defined research plans from concept through execution with precision, efficiency, and impactful results.
• Data Collection & Analysis Validated patient-reported data collection service using established methods and statistical analysis to capture the right data, using the right methods, from the right patients in support of COA endpoints.
• Interpretation & Communication End-to-end COA interpretation and communication service, providing comprehensive coverage from data-driven results through regulatory compliance deliverables to support sponsor decision-making.
• Quantitative Science Specialized quantitative service designing and executing COA-focused clinical research studies using advanced statistical methods, with expertise in psychometrics, biostatistics, and data analysis.
• Qualitative Science Innovative qualitative research service using interviews, focus groups, and other qualitative methodologies to uncover the human stories behind clinical data and inform COA strategy.
• Prospective Studies Service dedicated to designing and executing high-quality observational studies with expertise in study design, data management, and statistical analysis for real-world evidence generation.
• Evidence Synthesis Service that synthesizes literature, prior studies, and patient-focused evidence across PROs, ClinROs, ObsROs, and PerfOs to define what matters most to patients and select study endpoints.
• Research Operations Operational backbone service for COA research, providing project management, study coordination, data management, and day-to-day study execution support.
• Regulatory Advice & Support Specialized regulatory intelligence and submission support service for COA strategies across the drug development continuum, including FDA/EMA interactions.
• Psychometric Planning & Analytics Expert psychometric analysis service supporting COA validation and evaluation to meet regulatory standards for clinical outcome measures.

Quantifiable outcome

• COAScape AI achieves up to 95.5% agreement rate in literature review accuracy
• +1 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability6 records

Feature4 records

Partnerships

Three partnerships are on record, tiered core.

• Genesis ResearchcoreStrategic or Co-development Partner · 20 July 2022Clinical Outcomes Solutions partnered with Genesis Research in July 2022 to form a new era in life sciences collaboration, combining expertise in clinical outcomes assessment with complementary research capabilities.
• FingerPostcoreStrategic or Co-development Partner · 1 April 2022A five-year collaborative partnership between COS and FingerPost focused on delivering excellence in clinical outcomes research and evidence synthesis services.
• Carevive SystemscoreStrategic or Co-development PartnerClinical Outcomes Solutions partnered with Carevive Systems to improve the patient experience in cancer care through collaborative initiatives combining COA expertise with patient experience technology.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Parexel: Parexel is a major global CRO offering clinical development, regulatory consulting, and patient-centered outcome services. Comparable to COS in COA-related regulatory advisory work as part of a broader drug development services portfolio.
• Syneos Health: Syneos Health is a fully integrated biopharmaceutical solutions organization offering clinical development and commercialization services. Overlaps with COS on patient-centered outcomes work as part of broader CRO offerings to pharma and biotech sponsors.
• ICON plc: ICON plc is a top global CRO with significant COA/PRO consulting capacity following its PRA Health Sciences and Symphony Health integrations. Comparable to COS in serving pharma sponsors with COA-related trial services, though at much greater scale.
• IQVIA: IQVIA is one of the largest CROs with substantial real-world evidence, HEOR, and COA capabilities. Overlaps with COS on COA strategy and PRO consulting as part of a much broader clinical research services portfolio.
• Medidata Solutions: Medidata Solutions (a Dassault Systèmes company) provides the Rave eCOA platform and clinical trial technology. Comparable to COS in eCOA capture and trial-level patient outcome measurement, though technology-led rather than consulting-led.

Direct peers

• Signant Health: Signant Health (formerly Bracket) provides eCOA technology and COA/PRO scientific consulting for clinical trials. Closely comparable to COS in COA methodology, patient-reported outcome instruments, and sponsor-facing regulatory expertise.
• Evidera: Evidera (now part of PPD/Thermo Fisher Scientific) is a leading health economics, outcomes research, and COA/PRO consulting firm serving pharmaceutical sponsors. Directly comparable to COS in patient-reported outcomes strategy, COA development, and regulatory submission support for drug development.
• Clario: Clario is a clinical trial technology and eCOA solutions provider with deep COA/PRO expertise. Comparable to COS in serving pharmaceutical sponsors with COA instrument selection, validation, and electronic outcome assessment.
• Mapi Research Trust: Mapi Research Trust is a nonprofit that manages distribution and licensing of PRO and COA instruments. Highly comparable to COS in COA instrument expertise, patient-reported outcome research, and sponsor services around outcome measurement.

Emerging players

• Critical Path Institute: Critical Path Institute is a nonprofit that advances regulatory science and COA endpoint development through public-private partnerships. Comparable to COS in COA methodology and regulatory endpoint work, but pre-competitive and consortium-focused rather than sponsor-funded consulting.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/clinical-outcomes-solutions
• Xx.com/cos_coa

Compliance2 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 Clinical Outcomes Solutions