Catawba Research
Catawba Research is a full-service contract research organization providing clinical trial management services to pharmaceutical, biotech, medical device, and formulation development sponsors across dermatology, women's health, ophthalmology, and related therapeutic areas, using a fixed-fee delivery model.
- Company typePrivate
- Founded2014
- HeadquartersCharlotte, United States
- Headcount51–100
- GTM typeB2B
- OfferingServices
What Catawba Research does
Catawba Research is a privately held, full-service contract research organization (CRO) founded in 2014 and headquartered in Charlotte, NC, with an offshore operating subsidiary (Catawba Research India) in Mumbai. The company provides clinical trial management services to pharmaceutical, biotechnology, medical device, and formulation development sponsors, executing Phase II-IV studies under ICH-GCP across dermatology, respiratory, women's health, ophthalmology, gastroenterology, and neurology therapeutic areas. Its service portfolio spans Clinical Operations/Full Development Support, Trial Management, and Rater Training, Certification & Endpoint Quality, with a documented regulatory track record of 28 FDA approvals, 4 Health Canada approvals, and 1 DCGI (India) approval and zero FDA Form 483 reports across 42+ audited sites.
Catawba's delivery is organized around "The Catawba Way," a proprietary nimble methodology that supports both end-to-end strategic partnerships and functional service provider (FSP) engagements. The company pairs this with Fixed Model Pricing, a project-based fee structure under which 60% of projects complete with no change orders and 70%+ finish within originally contracted timelines. Supporting technical assets include indication-specific rater training video libraries (30+ minutes of content per therapeutic area), >90% eTMF completeness maintained continuously, and an integrated quality assurance function led by the CSO. Operations span the United States, Canada, Central America/Caribbean, and India, with qualified partner networks extending into Europe, Asia, and Australia.
Catawba generates revenue through professional services fees on multi-year clinical trial contracts, selling directly to enterprise sponsors via a "Request A Proposal" engagement model and supplementing capacity through partnerships (Elligo Health Research for patient access, Bingli for pre-screening, PharmaLegacy for APAC/China preclinical). Customer segments are diversified across large pharma, mid-cap biotech, and specialty formulation developers, with 80% of projects sourced from repeat customers. The company received institutional private equity backing from St. Cloud Capital in October 2020 and has since invested in commercial leadership additions (VPs of Project Management, Global Business Development, and Proposals) to support further scaling.
Catawba Research firmographics
Firmographics- Name
- Catawba Research
- Legal name
- Catawba Research, LLC
- Website
- https://catawbaresearch.com
- Company type
- Private
- Founded year
- 2014
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Catawba Research is a full-service contract research organization providing clinical trial management services to pharmaceutical, biotech, medical device, and formulation development sponsors across dermatology, women's health, ophthalmology, and related therapeutic areas, using a fixed-fee delivery model.
- Ownership category
- akta.pro rank
Catawba Research industry classification
Industry- 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)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL)
Keywords
Where Catawba Research is headquartered
LocationHeadquarters
- HQ city
- Charlotte
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Catawba Research business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure
Revenue model
- Clinical Research Services: Catawba Research provides clinical trial management services to pharmaceutical, device, formulation development and biotechnology companies. Revenue is generated through project-based fees using a fixed pricing model. The company manages Phase II-IV clinical trials and receives compensation for regulatory submission support services including NDA, 505(b)(2), and ANDA submissions.
- Data Management & Support Services (India): Through Catawba Research India located in Mumbai, the company provides clinical project management, data management, biostatistics and medical writing services as part of its comprehensive CRO offerings.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Fixed Model Pricing - Project-based fixed fee structure |
Go-to-market motion2 records
Distribution channels1 record
Marketing channels5 records
Catawba Research product offering
Product offeringCore offering
Catawba Research is a full-service contract research organization (CRO) that provides clinical trial management services to pharmaceutical, device, formulation development, and biotechnology companies. The company conducts and manages Phase II-IV clinical trials in accordance with ICH-GCP and applicable regulatory requirements, offering both end-to-end strategic service provider and functional service provider (FSP) delivery models across dermatology, respiratory, women's health, ophthalmology, gastroenterology, and neurology therapeutic areas.
Product overview
Catawba Research is a full-service Contract Research Organization (CRO) providing clinical trial management services to pharmaceutical, device, formulation development and biotechnology companies. The company operates a unified service model built around three core offerings: Clinical Operations/Full Development Support, Trial Management, and Rater Training/Certification & Endpoint Quality services. The Catawba Way proprietary delivery model unifies these services, enabling both end-to-end strategic partnerships and functional service provider (FSP) arrangements. The company specializes in six therapeutic areas: Dermatology, Respiratory, Women's Health, Ophthalmology, Gastroenterology, and Neurology. Catawba offers a Fixed Model Pricing approach for predictable budgeting. Operations span two headquarters in Charlotte, NC and Mumbai, India, with site networks across the U.S., Canada, Central America/Caribbean, and India, plus partner networks in Europe, Asia, and Australia. The Catawba Research India subsidiary provides dedicated data management, biostatistics, medical writing, and clinical operations services.
Differentiator
Problem solved
Functional benefit
Products and services
- Clinical Operations / Full Development Support
Quantifiable outcome
- 28 FDA approvals and 33 total regulatory approvals achieved
- +5 more outcomes
Companies that use Catawba Research
Customer profileNamed customers1 record
Segments4 records
Ideal customer profiles3 records
Catawba Research technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Catawba Research partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- PharmaLegacy LaboratoriescoreStrategic partnership announced October 22, 2024 to leverage both companies' strengths in driving innovation and excellence in drug development. Provides Catawba Research with new access to China, further expanding their APAC capabilities. This collaboration combines PharmaLegacy's preclinical contract research services with Catawba's clinical trial management expertise.
- Elligo Health ResearchcorePartnership to expand access and simplify clinical research participation announced December 6, 2023. Combined capabilities enhance Catawba's ability to provide comprehensive clinical trial services with improved patient access.
Scale indicators10 records
Recent moves8 records
Expansion highlights5 records
Catawba Research competitors and assessment
Company assessmentDirect peers
- Medpace: Mid-size, profitable, full-service CRO running Phase I-IV trials across multiple therapeutic areas with a similar model of cross-functional small teams. Comparable in scale, therapeutic breadth, and target customer profile (small-to-mid biopharma sponsors).
- Syneos Health: Full-service clinical CRO where Catawba's CEO Andrew Silverman previously served as EVP of Global Operations. Direct competitor in Phase II-IV trial management with overlapping therapeutic-area breadth and similar biopharma/biotech sponsor base.
- Premier Research: Specialty mid-size CRO with therapeutic-area focus (including dermatology, rare disease, CNS, oncology) serving small-to-mid biopharma. Comparable business model and customer profile, especially in dermatology where Catawba has documented depth.
- Novum Pharmaceutical Research Services: Specialty CRO with strong focus on 505(b)(2), ANDA, and generic-drug clinical trials, directly overlapping Catawba's regulatory-submission expertise and Phase II/III bioequivalence work.
- Worldwide Clinical Trials: Mid-size, mid-market-focused CRO providing Phase II-IV clinical trial management with therapeutic-area specialization. Directly comparable in scale and sponsor segment to Catawba.
Emerging players
- Elligo Health Research: Tech-enabled clinical research organization focused on expanding trial access. Partnered with Catawba in December 2023, indicating overlapping customer base and complementary capabilities in patient access/recruitment.
Broad incumbents
- Parexel International: Global full-service CRO with Phase I-IV clinical trial management. Competes with Catawba for mid-size sponsor business but operates at significantly larger scale and therapeutic breadth.
- ICON plc: Large global full-service CRO providing Phase I-IV trial management. Provides overlapping capabilities to Catawba but at much larger scale with broader portfolio of services.
- Labcorp Drug Development (formerly Covance): Large full-service clinical CRO with Phase I-IV capabilities and central laboratory services. Competes for enterprise CRO contracts that Catawba also targets with its full-service offering.
- IQVIA: Largest global CRO offering full Phase I-IV clinical trial management across all therapeutic areas. Represents the upper bound of competitive pressure Catawba faces for enterprise pharma contracts.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Catawba Research social profiles
Digital presenceCatawba Research financial estimates
Financial estimateRevenue estimate
Valuation estimate
Catawba Research leadership team
Management profileNumber of profiles
Profiles8 records
Catawba Research subsidiaries and ownership
Company hierarchySubsidiaries1 record
Catawba Research funding detail
Funding detailFunding overview
Funding rounds1 record
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Catawba Research 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 Catawba Research
What does Catawba Research do?
Catawba Research is a full-service contract research organization (CRO) that provides clinical trial management services to pharmaceutical, device, formulation development, and biotechnology companies. The company conducts and manages Phase II-IV clinical trials in accordance with ICH-GCP and applicable regulatory requirements, offering both end-to-end strategic service provider and functional service provider (FSP) delivery models across dermatology, respiratory, women's health, ophthalmology, gastroenterology, and neurology therapeutic areas.
Is Catawba Research a public or private company?
Catawba Research is a private company. It is classified as private equity controlled and is currently operating.
When was Catawba Research founded?
Catawba Research was founded in 2014. It employs 51 to 100 people.
Where is Catawba Research based?
Catawba Research is headquartered in Charlotte, United States, in the North America region.
How does Catawba Research make money?
Two revenue lines are on record. Clinical Research Services are the primary driver. The others are data Management & Support Services (India).
Who are Catawba Research's main competitors?
Direct peers on record are Medpace, Syneos Health, Premier Research, Novum Pharmaceutical Research Services and Worldwide Clinical Trials. Elligo Health Research is listed as an emerging player. Broad incumbents are Parexel International, ICON plc, Labcorp Drug Development (formerly Covance) and IQVIA.
Does Catawba Research have an API?
No public API is recorded for Catawba Research.
What industry is Catawba Research in?
Catawba Research's product category is Contract Research Organization (CRO) Services. Its primary akta.pro industry code is HLAGAAAL, Specialty Therapeutic-Area CROs (e.g., oncology/rare disease). Its NAICS code is 5417 and its SIC code is 8731.