LITMUS

What LITMUS does

LITMUS, operating under the legal name LITMUS – Clinical Research Group, is a privately held biopharmaceutical consulting firm headquartered in Miami Beach, Florida. Founded in 2010, the firm offers a portfolio of 13 service lines spanning the biopharmaceutical lifecycle, including Clinical Site Management, Clinical Trial Solutions, Data Management, Regulatory Affairs, Quality Assurance, Project Management, Medical Affairs, Medical Writing, Safety and Surveillance, Vendor Selection, Human Capital, Investigative Site Relations, and Continuous Quality Improvement. The company serves large, medium, and small pharmaceutical organizations as well as biotechnology companies, with documented client engagements spanning pharmaceutical companies in San Francisco, a biotechnology firm in San Diego, a global pharmaceutical company in Chicago, and a Latin America biopharma consulting firm in Buenos Aires. Service delivery has included a 55-site, 3-country clinical study in Latin America, demonstrating multi-region execution capability.

The firm's core technology consists of two proprietary assets: DOSE2, an engineered tool used to manage complexity and uncertainty across a continuum of time, and LITMUS 6.6.3, a performance monitoring framework structured around six core values, six value drivers, and three philanthropic focus areas. These tools supplement traditional biopharma operational components such as CRF/eCRF development, EDC and IXRS systems, and clinical trial master file management. The firm's claimed differentiators are decades of collective leadership experience (over 60 years), a worldwide network of relationships, and measurable client outcomes including 25% cost savings through clinical trial budget optimization and 10% cost savings through contract negotiation.

LITMUS operates as a B2B professional services firm with a consultative, enterprise field sales go-to-market motion. Revenue is generated through customized consulting engagements priced on a project basis, with no publicly disclosed pricing, no productized offerings, and no recurring subscription revenue. Distribution is direct to client decision-makers at pharmaceutical and biotechnology organizations, with no intermediary or reseller channels. The firm is led by Craig Amburgey (Founder, President, and Managing Partner, Clinical Development and Quality Assurance) and operates with a headcount of 1-10 employees. No external funding, institutional investors, or M&A activity is disclosed.

Name

LITMUS

Legal name

LITMUS – Clinical Research Group

Website

https://litmususa.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

1–10 employees

Short description

LITMUS is a privately held biopharmaceutical consulting firm offering 13 clinical research and drug development services to pharmaceutical and biotechnology organizations. The Miami Beach-based firm, founded in 2010, delivers customized project-based engagements spanning the full biopharmaceutical lifecycle.

Ownership category

akta.pro rank

Product category

Biopharmaceutical Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Management Consulting Services (54161)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro industry

PRIMARYHLAGAOAA

Clinical Operations & Monitoring FSP (CRA/CTM/Start-up)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Scientific Staffing & Functional Service Providers (FSP)

SECONDARYHLAGAOAG

Medical Affairs, Scientific Communications & HEOR FSP

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Scientific Staffing & Functional Service Providers (FSP)

SECONDARYHLAGAOAB

Data Management, Biostatistics & Statistical Programming FSP

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Scientific Staffing & Functional Service Providers (FSP)

SECONDARYHLAGAOAF

Pharmacovigilance, Drug Safety & Risk Management FSP

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Scientific Staffing & Functional Service Providers (FSP)

Keywords

• Biopharmaceutical consulting
• Clinical research services
• Regulatory affairs consulting
• Clinical trial management
• Medical writing services

Headquarters

HQ city

Miami Beach

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Consulting and Professional Services: LITMUS generates revenue through providing customized consulting services across the biopharmaceutical life-cycle. Services include Clinical Site Management, Clinical Trial Solutions, Continuous Quality Improvement, Data Management, Human Capital, Investigative Site Relations, Medical Affairs, Medical Writing, Project Management, Quality Assurance, Regulatory Affairs, Safety and Surveillance, and Vendor Selection. As a professional services firm, revenue is derived from consulting fees for tailored biopharmaceutical solutions.

Go-to-market motion1 record

Distribution channels1 record

Core offering

LITMUS is a global biopharmaceutical consulting firm that delivers customized professional services spanning the entire drug development lifecycle. Its portfolio covers 13 service lines including clinical site management, clinical trial solutions, data management, regulatory affairs, quality assurance, medical affairs, medical writing, project management, safety and surveillance, and vendor selection, supported by the proprietary DOSE2 management tool and the LITMUS 6.6.3 performance framework. Services are sold directly to pharmaceutical and biotechnology organizations of all sizes on a project/consulting engagement basis.

Product overview

LITMUS is a global consulting firm offering a comprehensive portfolio of integrated biopharmaceutical solutions spanning the entire drug development lifecycle. The company provides 13 distinct service offerings including Clinical Site Management, Clinical Trial Solutions, Continuous Quality Improvement, Data Management, Human Capital, Investigative Site Relations, Medical Affairs, Medical Writing, Project Management, Quality Assurance, Regulatory Affairs, Safety and Surveillance, and Vendor Selection. These services are complemented by DOSE2, a proprietary management tool designed to navigate complexity and uncertainty. The integrated approach delivers measurable outcomes including cost savings of up to 25% in budgeting and resource allocation, improved operational efficiency, and reduced client risk through the company's six value drivers.

Differentiator

Problem solved

Functional benefit

Brands

• LITMUS 6.6.3. A proprietary quality measurement framework using three qualifying questions to ensure LITMUS core values, value drivers, and philanthropic focus areas are integrated into daily activities.
• DOSE2

Products and services

• Clinical Site Management Comprehensive clinical site management services covering budgeting, contracting, site and investigator identification and selection, and subject recruitment, compliance, and retention for pharmaceutical and biotechnology sponsors.
• Clinical Trial Solutions End-to-end clinical trial support including protocol design, investigational brochure development, central IRB submissions, clinical monitoring plans, and trial master file management for biopharmaceutical sponsors.
• Continuous Quality Improvement Business process reengineering and standard operating procedure design, development, and reengineering for clinical, data management, investigational product, quality assurance, and regulatory functions.
• Data Management Data management services for clinical trials including CRF/eCRF development, data entry, data analysis, data management plan design, and source document template development.
• Human Capital Human capital solutions covering benefits management, diversity, employee relations, ethics, sustainability, labor relations, organizational development, talent management, and training from front-line to C-Suite.
• Investigative Site Relations Investigative site relations support including investigator meetings, study communications such as memos, newsletters, and webinars for clinical trial sponsors.
• Medical Affairs Medical affairs services for biopharmaceutical sponsors including expert opinion leader referrals and medical monitoring services across clinical programs.
• Medical Writing Medical writing services including clinical study reports and multi-functional plans and charters for biopharmaceutical development programs.
• Project Management Project management services including project plans, resource planning and allocation, and risk assessment and management for clinical development programs.
• Quality Assurance Quality assurance services including audit plan design, clinical trial file and document audits, investigational site audits, and vendor audits for biopharmaceutical sponsors.
• Regulatory Affairs Regulatory affairs services including Ministry of Health/Ethics Committee/IRB submissions and regulatory compliance and document management for biopharmaceutical development.
• Safety and Surveillance Safety and surveillance services including SAE identification, management, tracking, and reporting, and safety monitoring plan design and development for clinical trials.
• Vendor Selection Vendor selection and management services including contract negotiation, RFP process management for drug packaging, EDC, and IXRS systems, and vendor management for clinical programs.
• DOSE2 LITMUS-engineered proprietary tool used to manage complexity and uncertainty along a continuum of time, enabling teams to harness innovation in the midst of ambiguity for a competitive advantage on biopharmaceutical engagements.

Quantifiable outcome

• 25% cost savings achieved through aligned clinical trial financial plan and elimination of non-essential line items
• +1 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Scale indicators3 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• Celerion: Clinical research services provider offering clinical pharmacology, data management, biostatistics, and project management — overlapping meaningfully with LITMUS's Data Management, Project Management, and Clinical Trial Solutions offerings.
• Clinipace Worldwide: Mid-market CRO providing clinical operations, project management, regulatory, and biostatistics services to emerging and mid-sized biopharma — closely overlapping with LITMUS's target segments.
• Advanced Clinical: Mid-market CRO/FSP provider offering clinical research, staffing, and consulting services to pharma and biotech — closely comparable in FSP-style delivery and customer base.
• Cato Research (Cato SMS): Specialty CRO offering regulatory affairs, clinical development, project management, and biopharma consulting — closely aligned with LITMUS's regulatory and clinical operations services.
• CTI Clinical Trial & Consulting Services: Specialty CRO/FSP-style provider offering clinical research, project management, and regulatory affairs services to pharma and biotech — closely comparable in service breadth and mid-sized delivery model to LITMUS.

Broad incumbents

• Medpace: Mid-sized CRO providing full-service clinical development support to pharma and biotech, directly competing with LITMUS in clinical operations, project management, and regulatory services at meaningfully greater scale.
• IQVIA: Largest global CRO and life sciences services firm. Craig's prior employment at Quintiles (now IQVIA) explicitly positions IQVIA as a comparable reference; broad overlap in clinical operations, regulatory, and consulting services.
• ICON plc: Global CRO offering full-service clinical development, FSP, and consulting across the biopharma lifecycle — overlapping with LITMUS's services at far greater scale and geographic reach.
• Parexel International: Large global CRO providing clinical trial management, regulatory consulting, and biopharma advisory services — directly comparable in service mix to LITMUS but at meaningfully greater scale.
• Worldwide Clinical Trials: Mid-sized global CRO offering clinical trial management, project management, and biopharma consulting services similar to LITMUS's portfolio, but with substantially greater scale and infrastructure.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/litmusgroup
• LinkedInlinkedin.com/company/litmus-clinical-research-group

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 LITMUS