What InClin, Inc does

InClin, Inc. is a privately-held, full-service Contract Research Organization (CRO) founded in 1998 that delivers clinical research services to biotechnology and pharmaceutical sponsors from Phase 1 through Phase 4. The company operates from a San Mateo, California headquarters and a wholly-owned Australian subsidiary (InClin PTY LTD) in North Sydney, providing regional coverage in North America and the Asia-Pacific. Its customer base spans small biotech startups and enterprise pharmaceutical sponsors, with documented experience executing multinational registrational trials across up to 36 countries and 291 sites, including programs that have achieved NDA and EMA approvals.

The service portfolio covers Biometrics (data management, statistical analysis, CDISC-compliant SDTM/ADaM dataset development, and PK/PD analyses using Phoenix WinNonLin), Clinical Operations (project management, monitoring, feasibility, and Trial Master File management via Veeva Vault), Strategic Consulting, Medical Writing, Quality Assurance, Clinical Drug Safety and Pharmacovigilance (anchored on the Argus Safety database), and Medical Monitoring. The technology stack is built entirely on industry-standard third-party platforms rather than proprietary systems; differentiation is positioned on staff quality (averaging 20+ years of clinical research experience) and a regulatory track record that includes 3 successful NDA approvals and multiple FDA/EMA inspections with no 483 observations.

InClin generates revenue through custom professional services contracts on multi-year engagements. The go-to-market is sales-led, with direct business development outreach, quote-based pricing per engagement, and services contracted either as integrated single-source solutions or as standalone modules. The company is founder-owned: co-founders Arnold G. Wong (CFO) and Taylor T. Kilfoil (Chief International Officer) remain in active leadership roles alongside CEO Brian A. Horger, PhD (formerly of Genentech, Theravance Biopharma, and Covance Early Clinical Services). No external institutional investors, private equity backing, or parent company ownership is indicated in available data.

Name

InClin, Inc

Legal name

InClin, Inc.

Website

https://inclin.com

Company type

Private

Founded year

1998

Operating status

Operating

Headcount range

101–250 employees

Short description

InClin is a privately-held, full-service Contract Research Organization founded in 1998, providing Phase 1 through Phase 4 clinical research services (biometrics, clinical operations, drug safety, medical writing, QA, and monitoring) to biotech and pharmaceutical sponsors from offices in San Mateo, California and Sydney, Australia.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Scientific Research and Development Services (5417)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG)

Keywords

• Contract research organization
• Clinical trial services
• Biometrics and statistics
• Pharmacovigilance services
• Medical writing

Headquarters

HQ city

San Mateo

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. Contract Research Organization Services: InClin generates revenue as a full-service CRO providing integrated clinical research services from Phase 1 through Phase 4. Revenue is derived from service fees for biometrics, clinical operations, strategic consulting, medical writing, quality assurance, drug safety, and medical monitoring services. Services can be contracted as comprehensive single-source solutions or as standalone service modules.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

InClin is a full-service Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to manage Phase 1 through Phase 4 clinical trials. The company delivers integrated single-source solutions or standalone services spanning biometrics, clinical operations, strategic consulting, medical writing, quality assurance, drug safety and pharmacovigilance, and medical monitoring for drug development sponsors.

Product overview

InClin is a full-service Contract Research Organization (CRO) founded in 1998, offering an integrated suite of clinical research services from Phase 1 through Phase 4. The company operates as a single-source solution combining Biometrics, Clinical Operations, Strategic Consulting, Medical Writing, Quality Assurance, Clinical Drug Safety and Pharmacovigilance, and Medical Monitoring services. These core offerings work together as an integrated solution or can be engaged as standalone services to support biotech and pharmaceutical companies through the complete drug development lifecycle, from early clinical trials through regulatory approvals.

Differentiator

Problem solved

Functional benefit

Products and services

• Biometrics Integrated Biometrics department comprising Data Management, Statistical Analysis and Programming for clinical development. Covers protocol development, CRF development, database design across multiple EDC platforms, CDISC standards (SDTM and ADaM), regulatory submissions, pharmacokinetics/pharmacodynamics analyses using Phoenix WinNonLin, and statistical programming for NDA submissions. For biotech and pharmaceutical sponsors.
• Clinical Operations Phase 1 to 4 clinical research services covering project management, project planning (timeline optimization, country selection, feasibility, study start-up, vendor management), clinical monitoring and site management, feasibility assessments, and Trial Master File management via Veeva Vault. For biotech and pharmaceutical sponsors.
• Strategic Consulting Strategic consulting on planning and execution of clinical trials, including experimental design and program optimization for drug development sponsors. For biotech and pharmaceutical companies.
• Medical Writing Production of high-quality medical documents for drug development sponsors, including clinical study reports, regulatory submissions, publications, and other clinical development documentation with efficient turnaround times.
• Quality Assurance Inspection readiness gap assessment and risk mitigation strategic consulting provided by QA professionals with expertise in regulatory compliance and quality management. For biotech and pharmaceutical sponsors.
• Clinical Drug Safety and Pharmacovigilance Customized drug safety monitoring solutions for evaluation, processing, site interaction, and regulatory reporting using Argus Safety database. Services include safety case processing, risk management, regulatory reports (DSUR, IND annual reports), and drug safety auditing. For biotech and pharmaceutical sponsors.
• Medical Monitoring Strategic consulting and medical monitoring services provided by a team of medical experts across multiple therapeutic indications. For biotech and pharmaceutical sponsors.

Quantifiable outcome

• 3 successful NDA approvals for Phase 1-3 clinical development programs
• +3 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration5 records

Feature5 records

Scale indicators5 records

Recent moves7 records

Expansion highlights3 records

Direct peers

• Medpace: Mid-size, profitable, full-service clinical CRO focused on small/mid-cap biotech and pharma. Closely comparable to InClin in therapeutic breadth, sponsor segment, and integrated Phase 1–4 service model — the relevant public-market benchmark.
• Worldwide Clinical Trials: Mid-tier global CRO with comparable full-service Phase 1–4 capabilities and strong scientific/medical affairs emphasis. Directly competes for the same small/mid-cap biotech and specialty pharma sponsors as InClin.
• Premier Research: Specialty CRO providing full-service clinical development with emphasis on biotech, rare disease, and specialty therapeutic areas. Highly comparable in sponsor segment and mid-tier scale.
• Caidya (formerly dMed): PE-backed (KKR) mid-tier full-service CRO with integrated biometrics, clinical operations, and regulatory services. Closely comparable in service mix and biotech sponsor focus; an example of a scaled-up version of InClin's model.
• Clinipace Worldwide: Mid-size, privately-held full-service CRO serving small and mid-sized biopharma with adaptive trial designs and integrated biometrics. Comparable scale, sponsor segment, and ownership profile.

Broad incumbents

• ICON plc: One of the top global full-service CROs post-PRA Health acquisition. Overlaps with every InClin service line and increasingly competes for mid-cap biotech business, but operates at vastly larger scale.
• IQVIA: Largest global CRO and life sciences technology provider with end-to-end Phase 1–4 services, real-world data, and analytics. Represents the upper-bound competitive threat; smaller biotech sponsors often default to IQVIA for integrated programs.
• Syneos Health:
• Labcorp Drug Development (formerly Covance): One of the largest global CROs with full Phase 1–4 services plus central labs — and the historical employer of multiple InClin leaders (e.g., CEO Brian Horger was Director of BD at Covance Early Clinical). Direct talent and capability overlap.
• PPD (Thermo Fisher): Top-tier global CRO (now part of Thermo Fisher Scientific) with full-service Phase 1–4 capabilities. A relevant scale benchmark and direct competitor for mid-cap biotech clinical work.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/inclin-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries1 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 InClin, Inc