Proxima Clinical Research Inc.

What Proxima Clinical Research Inc. does

Proxima Clinical Research Inc. (doing business as Proxima CRO) is a contract research organization founded in November 2017 and incorporated as a Delaware C Corporation, headquartered at 2450 Holcombe Blvd in the Texas Medical Center in Houston, Texas. The company provides integrated regulatory, clinical, and quality management services to medical device, pharmaceutical, biotechnology, and diagnostic companies, with a strategic emphasis on emerging MedTech and biotech innovators. Proxima operates across 17 countries and five continents, has served more than 300 clients across 35+ therapeutic and industry segments, and has supported enrollment of over 5,000 patients in clinical trials. The company employs 11-50 staff and earned multiple growth and workplace awards, including Inc. 5000 (top 25% fastest-growing US private companies), Inc. Best in Business, and Great Place to Work certification.

Proxima's core service offering spans three integrated lines: Regulatory Services covering FDA pathways across both CDER and CDRH (510(k), PMA, De Novo, IDE, HDE, BDD, IND, NDA, BLA, 505(b2), and RMAT), Clinical Services for Phase I-IV trial design and management, and Quality Management Services including QMS development, eQMS installation, audit support, and 21 CFR Part 820 compliance. Underlying the offering is an agile-based project management methodology combined with therapeutic-area expertise rather than a proprietary software platform. The company has developed specialist expertise in AI/ML-enabled medical device regulatory strategy, serving clients such as Prenosis on novel AI-driven diagnostics, and offers complementary capabilities including QMS Transition Consulting aligned with the FDA QMSR transition effective February 2026 and a free Breakthrough Device Designation assessment tool. Data aggregator partnerships provide clients access to EMR, Labs, Claims, Remits, Charge Master, and Specialty Rx data.

Proxima's revenue model is project-based professional services with quote-driven, custom-engagement pricing typical of CROs. Its go-to-market is sales-led, combining direct enterprise sales to both emerging startups and Fortune 500 life sciences firms with accelerator partnerships (MedTech Innovator and the M1 MedTech accelerator co-founded by CEO Kevin Coker), content marketing, webinars, industry conferences, and the "Inventing Tomorrow" podcast. In October/November 2025 the company was acquired and industry veteran Eric Ross was appointed as the new CEO to drive growth in the Houston MedTech hub, succeeding co-founder Kevin Coker.

Name

Proxima Clinical Research Inc.

Legal name

Proxima Clinical Research Inc.

Website

https://proximacro.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

Proxima CRO is a Houston-based contract research organization providing integrated regulatory, clinical trial, and quality management services to 300+ medical device and biotech companies across 17 countries, using agile-based project delivery and deep FDA pathway expertise.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

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

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industry

Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL)

Keywords

• Contract research organization
• Regulatory affairs consulting
• Clinical trial management
• Quality management systems
• Medical device regulatory

Headquarters

HQ city

Houston

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, Infrastructure

Revenue model

1. CRO Professional Services: Proxima generates revenue by providing integrated regulatory strategy, clinical trial management, and quality management services to medical device, biotech, pharmaceutical, and diagnostic companies. Services are tailored to client needs across phases from early development through commercialization.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels7 records

Core offering

Proxima Clinical Research is a Contract Research Organization (CRO) providing integrated regulatory strategy, clinical trial management, and quality management services to medical device, biotech, pharmaceutical, and diagnostic companies. It delivers FDA pathway support (510(k), De Novo, PMA, IDE, BDD, HDE, IND, NDA, BLA, 505(b2), RMAT), Phase I-IV clinical trial design and execution, quality system development, and post-market surveillance, leveraging agile-based project management and deep therapeutic expertise across 35+ segments.

Product overview

Proxima Clinical Research is a Contract Research Organization (CRO) offering an integrated suite of regulatory, clinical, and quality management services for medical device and biotech companies. The core offering consists of Regulatory Services (strategy, filings, and submissions for FDA pathways including 510(k), PMA, De Novo, IDE, IND), Clinical Services (Phase I-IV clinical trial management with agile processes), and Quality Management Services (QMS development, audits, and manufacturing support). Additional offerings include QMS Transition Consulting for FDA QMSR 2026 compliance, a Breakthrough Device Designation resource tool, and data aggregator partnerships providing access to EMR, Labs, Claims, and specialty pharmacy data. The company serves MedTech and Biotech industries across therapeutic areas including Oncology, Cardiovascular, Neuromodulation, Pediatrics, Orthopedics & Spine, In-Vitro Diagnostics, and General Surgery.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Services Regulatory strategy, filings, submissions, and dossiers for CDER and CDRH pathways including Q-sub, IDE, 510(k), PMA, De Novo, BDD, HDE, IND, NDA, BLA, 505(b2), and RMAT for medical device, drug, and diagnostic companies.
• Clinical Services Clinical trial management and monitoring using agile processes combined with leading experts and technology for Phase I-IV device and drug clinical projects for medical device, biotech, pharmaceutical, and diagnostic sponsors.
• Quality Management Services Quality system and manufacturing support including SOP drafting, eQMS installation, audit support, and manufacturer auditing for medical device, biotech, and pharmaceutical companies to achieve and maintain ISO 13485 and 21 CFR Part 820 compliance.
• Data Aggregator Partnerships Partnerships with data aggregators enabling commercial teams at clients to access EMR, Labs, Claims, Remits, Charge Master, and Specialty Rx data from world-class institutions.

Quantifiable outcome

• 300+ clients served across medical device, pharmaceutical, biotechnology, and diagnostic sectors
• +3 more outcomes

Named customers6 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Two partnerships are on record, tiered minor and core.

• First Bight VenturesminorStrategic or Co-development Partner · 1 April 2022Kevin Coker, co-founder and CEO of Proxima CRO, joined First Bight Ventures' advisory board. First Bight Ventures is a Houston-based venture capital fund focused exclusively on early-stage synthetic biology startups, founded by Veronica Wu, former Apple and Tesla exec.
• MedTech InnovatorcoreStrategic or Co-development PartnerProxima CRO partners with MedTech Innovator to support startups in their accelerator programs. The company has partnered with MedTech Innovator for multiple years, providing free regulatory strategies as part of contests and supporting cohort companies through mentorship and industry connections. Kevin Coker serves as an advocate for MedTech Innovator.

Scale indicators6 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Medpace: Full-service CRO with a strong MedTech and biotech franchise offering clinical trial management, regulatory, and quality services. Highly comparable to Proxima in target customer mix, though materially larger and publicly traded.
• NAMSA: Medical-device-focused CRO and regulatory consultancy serving MedTech OEMs with preclinical, clinical, and quality services. Directly comparable to Proxima's medical device regulatory and clinical offering.
• Premier Research: Specialty CRO serving emerging biotech and MedTech sponsors across regulatory, clinical, and quality functions. Comparable in customer segment focus and integrated service model to Proxima.

Broad incumbents

• Charles River Laboratories: Large CRO/CDMO with broad discovery, preclinical, and clinical services including medical device safety and regulatory consulting. Overlaps with Proxima on clinical and quality services but operates at much greater scale.
• IQVIA: World's largest CRO with full-spectrum clinical, regulatory, and quality services plus real-world evidence and data assets. Comparable in service breadth but materially larger and competes for the same enterprise MedTech/biotech RFPs.
• ICON plc: Global CRO offering Phase I-IV clinical, regulatory, and laboratory services across devices, drugs, and diagnostics. Comparable service portfolio to Proxima at significantly larger scale and global footprint.

Emerging players

• Worldwide Clinical Trials: Mid-sized CRO focused on complex early- and late-phase trials in CNS, oncology, and rare disease. Comparable in its specialty therapeutic focus but with broader geographic reach than Proxima.
• Clinipace Worldwide: Mid-market CRO providing clinical, regulatory, and biometrics services to emerging and mid-sized biopharma and MedTech. Comparable in customer segment and full-service scope, though larger than Proxima.
• RQM+: Medical device-focused regulatory and quality consulting firm supporting 510(k), PMA, CE Mark, and ISO 13485 compliance. Directly comparable to Proxima's regulatory and quality service lines for MedTech sponsors.

Others

• BioAgilytix: Specialized bioanalytical and biomarker testing CRO serving pharma and biotech. Adjacent rather than directly competing, but commonly co-served alongside CROs like Proxima in integrated biotech development programs.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/@proximacro
• LinkedInlinkedin.com/company/27208825
• Xx.com/proximacro

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 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 Proxima Clinical Research Inc.