Berry Consultants
Berry Consultants is a privately-held Bayesian adaptive clinical trial design and consulting firm founded in 2000, serving top global pharmaceutical, medical device, academic, and government clients with proprietary FACTS, ADDPLAN, and QUOTES simulation software and expert trial design services.
- Company typePrivate
- Founded2000
- HeadquartersAustin, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Berry Consultants does
Berry Consultants is a privately-held, founder-owned scientific consulting firm founded in 2000 in Austin, Texas by Dr. Don Berry and Dr. Scott Berry, specializing in Bayesian adaptive clinical trial design, analysis, and software for the pharmaceutical and medical device industry. The firm designs adaptive trials — including platform, seamless Phase 2/3, and response-adaptive randomized designs — and provides trial implementation services spanning interim and final analyses, DSMB interactions, and regulatory strategy. Berry Consultants contributed to the first fully Bayesian FDA approval and to landmark trials such as Eli Lilly's dulaglutide seamless Phase 2/3 (expediting development by an estimated 12-18 months), Eisai/Biogen's lecanemab Alzheimer's program (where Phase 2 Bayesian estimates later matched Phase 3), Ferring's SEPSIS-ACT, and major platform trials including I-SPY 2, REMAP-CAP, and HEALEY ALS.
The company's underlying technology stack centers on proprietary Bayesian adaptive trial methodology codified into three software products: FACTS (Fixed and Adaptive Clinical Trial Simulator), licensed to approximately 40% of the top 25 global pharmaceutical companies and now in version 8 (October 2025) with ordinal endpoint support; ADDPLAN, an acquired brand for group sequential and adaptive design tools (version 10.2 in April 2024); and QUOTES, which estimates expected net present value of drug development programs. The methodology encompasses response-adaptive randomization, predictive probability calculations, longitudinal modeling, and a 'time machine' approach for platform trials.
Berry Consultants operates a dual revenue model combining professional services (adaptive trial design consulting, Bayesian analysis, trial implementation, and regulatory guidance) with subscription-based software licensing of FACTS, ADDPLAN, and QUOTES to pharma, medical device, academic, and government clients globally. Go-to-market is enterprise field sales driven by thought leadership — peer-reviewed publications, the 'In the Interim...' podcast, webinars, and principal sponsorship of ASA, JSM, and Society for Clinical Trials events — supplemented by a January 2025 European expansion anchored by a Senior Medical Scientist hire. The firm has no external funding, is profitable and founder-led, and operates with 11-50 employees.
Berry Consultants firmographics
Firmographics- Name
- Berry Consultants
- Legal name
- Berry Consultants, LLC
- Website
- https://berryconsultants.com
- Company type
- Private
- Founded year
- 2000
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Berry Consultants is a privately-held Bayesian adaptive clinical trial design and consulting firm founded in 2000, serving top global pharmaceutical, medical device, academic, and government clients with proprietary FACTS, ADDPLAN, and QUOTES simulation software and expert trial design services.
- Ownership category
- akta.pro rank
Berry Consultants industry classification
Industry- Product category
- Clinical Trial Statistics & Adaptive Trial Design Consulting
- NAICS
- Management Consulting Services (54161), Other Scientific and Technical Consulting Services (54169)
- SIC
- Services-Management Consulting Services (8742)
- akta.pro primary industry
- Clinical Development (Phase I–III Trial Design & Execution) (HLAIALAE)
- akta.pro secondary industries
- Clinical Trial Analytics, Risk-Based Monitoring (RBM) & Quality Management (HLACAOAI), Precision Clinical Trials Enablement (patient matching, site matching, adaptive trials) (HLAAANAI)
Keywords
Where Berry Consultants is headquartered
LocationHeadquarters
- HQ city
- Austin
- HQ country
- United States
- HQ region
- North America
Markets served
Berry Consultants business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Operations
Revenue model
- Clinical Trial Design Consulting Services: Expert consulting services for adaptive clinical trial design, Bayesian analysis, trial implementation, and regulatory strategy for pharmaceutical and medical device companies. Services include interim and final analyses, DSMB support, and adaptive design implementation guidance.
- Software Licensing (FACTS, ADDPLAN, QUOTES): Licensing of proprietary clinical trial simulation software to pharmaceutical companies, academic institutions, and government organizations. FACTS software is licensed to 40% of top 25 pharmaceutical companies, ADDPLAN for group sequential designs, and QUOTES for drug development program optimization.
Go-to-market motion1 record
Distribution channels2 records
Marketing channels6 records
Berry Consultants product offering
Product offeringCore offering
Berry Consultants is a scientific consulting company that designs adaptive clinical trials and provides supporting simulation software for the pharmaceutical and medical device industry. The firm offers expert Bayesian trial design consulting (interim/final analyses, DSMB support, regulatory strategy) alongside proprietary software products FACTS, ADDPLAN, and QUOTES that biostatisticians use to design, compare, and simulate fixed and adaptive trial designs. Its work spans adaptive Phase 2/3 seamless trials, platform trials (I-SPY 2, REMAP-CAP, HEALEY ALS), and dose escalation studies for industry, government, and academic clients globally.
Product overview
Berry Consultants is a scientific consulting company offering a portfolio of clinical trial software products and specialized services. The core product is FACTS (Fixed and Adaptive Clinical Trial Simulator), a powerful simulation platform for designing and evaluating adaptive trial designs. ADDPLAN provides group sequential design tools (acquired brand), while QUOTES focuses on trial design optimization and NPV estimation. Together with consulting services for adaptive trial design, trial implementation, Bayesian analysis, and platform trials, the company provides end-to-end solutions for the pharmaceutical and medical device industry. The software tools are licensed to major pharmaceutical companies worldwide and support complex adaptive designs including early stopping, arm dropping, and response-adaptive randomization.
Differentiator
Problem solved
Functional benefit
Brands
- FACTS: Fixed and Adaptive Clinical Trial Simulator - software solution for designing and simulating clinical trials
- In the Interim...
Products and services
- FACTS (Fixed and Adaptive Clinical Trial Simulator) Clinical trial simulation software that helps biostatisticians rapidly design, compare, and simulate both fixed and adaptive trial designs, with features for early stopping, arm dropping, Bayesian predictive probabilities, and dose escalation designs. Licensed to approximately 40% of the top 25 pharmaceutical companies globally.
- ADDPLAN Software for adaptive trial design providing tools for group sequential designs, stopping boundaries, interim test statistic estimates, and illustrative examples for non-statisticians.
- QUOTES Clinical trial design optimization software that estimates the expected net present value of drug development programs and addresses trade-offs in Phase 2 trials.
- Adaptive Clinical Trial Design Services Consulting services for designing adaptive clinical trials with pre-specification of flexible components including treatment arms, allocation ratios, patient populations, and sample size, for pharmaceutical and medical device clients.
- Trial Implementation Services Services including interim and final analyses for primary and key secondary efficacy endpoints, expert guidance on adaptive design implementation, and DSMB interactions for adaptive and platform trials.
- Bayesian Analysis Services Expert consulting in Bayesian adaptive clinical trial methodology, platform and basket trials, and clinical trials incorporating historical information.
- Platform Trials Services Design and implementation of innovative clinical trials that evaluate multiple treatments simultaneously and continue beyond evaluation of any one treatment, maximizing statistical and clinical efficiency.
Quantifiable outcome
- Reduced drug development timeline by 12-18 months for GLP-1 agonist dulaglutide through seamless Phase 2/3 adaptive design
- +2 more outcomes
Companies that use Berry Consultants
Customer profileNamed customers4 records
Segments4 records
Ideal customer profiles4 records
Berry Consultants technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration1 record
Feature4 records
Berry Consultants partnerships and signals
Strategic signalScale indicators6 records
Recent moves6 records
Expansion highlights6 records
Berry Consultants competitors and assessment
Company assessmentBroad incumbents
- ICON plc: Top-3 global CRO offering biostatistics, adaptive trial design, and regulatory consulting. Competes with Berry on large pharma full-service bids that include adaptive trial design components.
- IQVIA: World's largest CRO with biostatistics and clinical trial design services, including adaptive design offerings. Competes with Berry on enterprise pharma engagements and bundled full-service trial delivery.
- Medidata (Dassault Systèmes): Major clinical trial technology platform offering EDC, RTSM, and analytics. While broader than Berry, Medidata increasingly embeds adaptive trial capabilities and competes for the same pharma R&D technology budgets.
- SAS Institute: Enterprise analytics and statistical software giant with clinical trial solutions. Competes more on statistical software infrastructure than bespoke adaptive trial design, but overlaps with Berry's software footprint in pharma.
- Labcorp Drug Development (Fortrea): Large CRO (post-Labcorp spin-off as Fortrea) with central laboratory and biostatistics services, including adaptive trial capabilities. Overlaps with Berry as a one-stop clinical development partner to pharma.
Direct peers
- Cytel: Specialty statistical software and services company offering adaptive trial design software (East, Solara) and Bayesian consulting. Closest direct competitor to Berry in the adaptive trial design niche, serving many of the same top-25 pharma clients.
- Theorem Clinical Research: Specialty CRO with strong adaptive trial and complex trial design practice. Directly competes with Berry on statistical methodology and adaptive trial execution for mid-sized pharma and biotech sponsors.
Emerging players
- Veristat: Mid-sized clinical development and biostatistics CRO with adaptive design expertise, focused on oncology and rare disease trials. Direct overlap with Berry in statistical consulting for smaller pharma and biotech.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat6 records
Key risks6 records
Key highlights6 records
Customer concentration
Berry Consultants social profiles
Digital presenceBerry Consultants financial estimates
Financial estimateRevenue estimate
Valuation estimate
Berry Consultants leadership team
Management profileNumber of profiles
Profiles4 records
Berry Consultants funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Berry Consultants M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Berry Consultants
What does Berry Consultants do?
Berry Consultants is a scientific consulting company that designs adaptive clinical trials and provides supporting simulation software for the pharmaceutical and medical device industry. The firm offers expert Bayesian trial design consulting (interim/final analyses, DSMB support, regulatory strategy) alongside proprietary software products FACTS, ADDPLAN, and QUOTES that biostatisticians use to design, compare, and simulate fixed and adaptive trial designs. Its work spans adaptive Phase 2/3 seamless trials, platform trials (I-SPY 2, REMAP-CAP, HEALEY ALS), and dose escalation studies for industry, government, and academic clients globally.
Is Berry Consultants a public or private company?
Berry Consultants is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Berry Consultants founded?
Berry Consultants was founded in 2000. It employs 11 to 50 people.
Where is Berry Consultants based?
Berry Consultants is headquartered in Austin, United States, in the North America region.
How does Berry Consultants make money?
Two revenue lines are on record. Clinical Trial Design Consulting Services are the primary driver. The others are software Licensing (FACTS, ADDPLAN, QUOTES).
Who are Berry Consultants's main competitors?
Broad incumbents on record are ICON plc, IQVIA, Medidata (Dassault Systèmes), SAS Institute and Labcorp Drug Development (Fortrea). Direct peers are Cytel and Theorem Clinical Research. Veristat is listed as an emerging player.
Does Berry Consultants have an API?
No public API is recorded for Berry Consultants.
What industry is Berry Consultants in?
Berry Consultants's product category is Clinical Trial Statistics & Adaptive Trial Design Consulting. Its primary akta.pro industry code is HLAIALAE, Clinical Development (Phase I–III Trial Design & Execution), with a secondary code of HLACAOAI, Clinical Trial Analytics, Risk-Based Monitoring (RBM) & Quality Management. Its NAICS code is 54161 and its SIC code is 8742.