Helios Clinical Research

What Helios Clinical Research does

Helios Clinical Research is a privately held, US-based clinical trial site network that operates 20+ research sites across eight states — Texas, California, Florida, Arizona, Arkansas, New Jersey, Ohio, and Tennessee — supporting Phase II–IV trials in oncology, neurology, cardiology, vaccines, and other therapeutic areas. The company is headquartered in Fort Worth, Texas, with an additional office in New York, and was co-founded by Stephen DeCherney (MD, MPH, formerly President of Quintiles/IQVIA Global CRO), E.B. McLindon (formerly SVP at ICON plc and co-founder of Accelovance), and Natalie Gassen (formerly CFO of Allucent, now serving as CFO/COO).

The core offering is a centralized site operations platform combined with locally tailored patient recruitment. Centralized functions include project management, protocol feasibility, finance and contracts, patient engagement, training and quality assurance, and innovation and technology, while each site is staffed with lead coordinators, phlebotomists, laboratory personnel, recruitment specialists, and pharmacists supporting principal investigators. The technology stack comprises a Clinical Trial Management System (CTMS) for subject management, electronic registry (e-reg) solutions enabling remote CRA visits, the HeliosStudies Patient Registry for pre-screening and patient matching, the Helios Heroes Referral Program for direct patient acquisition, and HubSpot as the CRM. Helios maintains a broad compliance posture spanning HIPAA, GCP, SOC 2 Type II, SOC 3, ISO 27001, HITRUST CSF, GDPR, and multiple US state privacy regimes.

Helios generates revenue by providing clinical trial site services to biopharma sponsors under a single contract covering all network sites, with go-to-market executed through direct enterprise sales to sponsors (BD contact: [email protected]), channel partnerships with physician practices and hospitals that become trial sites with embedded Helios staff, and direct-to-consumer patient recruitment via website pre-screening, the Helios Heroes referral program, and community outreach. Named enterprise customers include AstraZeneca, GSK, Sanofi, IQVIA, Parexel, and PPD (Thermo Fisher Scientific), and the network has cumulatively executed 650+ research trials supporting 20,000 patients, with a notable milestone of randomizing 501 patients across 8 sites in 19 weeks for an RSV vaccine study in which sites ranked in the top 10.

Name

Helios Clinical Research

Legal name

Helios Clinical Research

Website

https://heliosclinical.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

101–250 employees

Short description

Helios Clinical Research is a privately held US clinical trial site network operating 20+ sites across 8 states, providing Phase II–IV site services, patient recruitment, and centralized trial operations to biopharma sponsors, with additional physician partnership and direct-to-consumer patient programs.

Ownership category

akta.pro rank

Product category

Clinical Research Services

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417)

SIC

Services-Specialty Outpatient Facilities, Nec (8093), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical Trial Site Operations & Study Coordination (HLAGACAE)

akta.pro secondary industry

Investigator & Site Training / GCP Support (HLAGACAF)

Keywords

• Clinical trial services
• Clinical site network
• Patient recruitment
• Biopharma research
• Clinical research operations

Headquarters

HQ city

New York

HQ country

United States

HQ region

North America

Offices28 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Trial Services: Helios generates revenue by providing clinical trial site services to biopharma sponsors. The network enables sponsors to access multiple research sites through a single contract/budget, supporting Phase II-IV trials across therapeutic areas. Services include site selection, patient recruitment, study coordination, and data collection.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels5 records

Core offering

Helios Clinical Research operates an integrated network of 20+ clinical trial sites across the United States that delivers Phase II-IV clinical trial services to biopharma sponsors. Sponsors access the network via a single contract covering all sites, while Helios combines centralized operations (project management, feasibility, finance, contracts, QA, training) with locally tailored patient recruitment at each site. The company supports therapeutic areas including oncology, neurology, cardiology, vaccines, and others, and embeds clinical research staff at physician practice and hospital partner sites to reduce investigator burden.

Product overview

Helios Clinical Research is a fully integrated clinical site network that operates as a unified platform connecting biopharma sponsors with research sites and patients. The portfolio consists of the HeliosStudies Patient Registry for patient recruitment and matching, a network of 20+ clinical trial sites across multiple states, Current Studies Portal for trial discovery, Sponsor Services Platform providing integrated trial management (project management, feasibility, training, quality assurance), and Physician Partnership Program with embedded staff support. Additional offerings include the Helios Heroes Referral Program, Privacy & Data Security Services, and HIPAA Privacy Compliance. The company focuses on Phase II-IV trials across therapeutic areas including oncology, neurology, cardiology, vaccines, and more, with centralized operations and localized recruitment outreach.

Differentiator

Problem solved

Functional benefit

Products and services

• HeliosStudies Patient Registry Patient registry and pre-screening platform that lets individuals register their interest in clinical trials; clinical research specialists review submissions and match potential participants with eligible studies at Helios network sites.
• Clinical Site Network Network of 20+ clinical trial sites across Texas, California, Florida, Arizona, Tennessee, Ohio, Arkansas, and New Jersey that conducts Phase II-IV clinical trials across therapeutic areas including oncology, neurology, cardiology, and vaccines.
• Sponsor Services Platform Integrated clinical trial support services for biopharma sponsors including project management, protocol feasibility, finance and contracts, patient engagement, training and quality assurance, and innovation and technology, delivered across all Helios sites under a single contract.
• Physician Partnership Program Partnership model for physicians and healthcare organizations to participate in clinical research, with embedded Helios staff (coordinators, phlebotomists, lab personnel, recruitment specialists, pharmacists), training, quality assurance, and access to emerging therapies for their patients.

Quantifiable outcome

• Drove randomization of 501 patients at eight sites in 19 weeks for RSV vaccine study
• +2 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

Integration5 records

Feature3 records

Partnerships

Eight partnerships are on record, tiered core, minor and founding.

• IQVIAcoreStrategic or Co-development PartnerIQVIA is listed as a Partner. IQVIA is a leading global provider of clinical research services, and this partnership likely involves collaboration on clinical trial execution and site services.
• ParexelcoreStrategic or Co-development PartnerParexel is listed as an Alliance Site partner. Parexel is a major CRO and the partnership provides Helios sites access to Parexel's sponsor relationships.
• PPD (Thermo Fisher Scientific)minorStrategic or Co-development PartnerPPD is listed as a Select Program Member. PPD is a global CRO and this partnership may involve site services for PPD-managed trials.
• AstraZenecacoreChannel Partner/ Reseller/ DistributorAstraZeneca is listed as a Site Partner. As a major pharmaceutical company, AstraZeneca sponsors clinical trials that Helios sites participate in.
• GSKcoreChannel Partner/ Reseller/ DistributorGSK is listed as a Site Partner. GSK sponsors clinical trials that Helios sites participate in.
• SanoficoreChannel Partner/ Reseller/ DistributorSanofi is listed as a Site Partner. Sanofi sponsors clinical trials that Helios sites participate in.
• AMRC Org.foundingStrategic or Co-development PartnerAMRC Org. is listed as a Founding Member, indicating a foundational strategic partnership in the Helios network.
• The Oncology InstitutecoreChannel Partner/ Reseller/ DistributorMultiple The Oncology Institute locations across California and Florida are operated as Helios-powered sites, expanding the network's oncology research capabilities.

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Fortrea (formerly Labcorp Drug Development): Fortrea is a leading global CRO spun out from Labcorp in 2023, providing clinical development and site services. Overlaps with Helios in Phase II-IV site execution and biopharma sponsor relationships.
• IQVIA: IQVIA (formerly Quintiles) is the world's largest CRO and operates an extensive proprietary site network including the Prime Site program. Helios's Chairman Stephen DeCherney was previously President of Quintiles Global CRO. Functions both as a Helios partner and a competitor through its embedded site solutions.
• ICON plc: ICON is a top-3 global CRO with significant site operations including the legacy Accelovance and PRA Health site assets and dedicated site and patient strategy. Helios's CEO E.B. McLindon previously led site and patient strategy at ICON. Competes at the project level via its in-house site network.
• Syneos Health: Syneos Health is a fully integrated biopharmaceutical solutions organization offering both CRO and site management services via its Site Solutions Group. Directly addresses biopharma sponsors with site network capability overlapping Helios's model.
• PPD / Thermo Fisher Scientific: PPD, a subsidiary of Thermo Fisher Scientific, is one of the world's largest CROs with site management and patient enrollment capabilities. Listed as a Helios Select Program Member, representing both partnership and competitive overlap.
• Parexel: Parexel is a top-tier global CRO with dedicated site alliance and patient recruitment programs. Listed as an Alliance Site partner of Helios; comparable enterprise CRO offering overlapping clinical trial execution services to the same sponsor customer base.

Direct peers

• Velocity Clinical Research: Velocity Clinical Research is one of the largest therapeutic-area-diversified SMO networks in the US, operating ~90+ sites globally and enrolling across Phase II-IV. Directly comparable multi-site platform serving biopharma sponsors with a single-contract model similar to Helios's value proposition.
• Accelovance: Accelovance is a US-based clinical research site network originally co-founded by Helios's CEO E.B. McLindon, recognized as Best Vaccine CRO at the 2009-2011 World Vaccine Congress. Operates a comparable SMO/specialty CRO model focused on vaccines, oncology, and women's health trials.
• WCCT Global: WCCT Global is an SMO running multi-therapeutic clinical trial sites across the US, including Phase I and vaccine capability. Overlaps directly with Helios in mid-size SMO site operations serving biopharma sponsors with embedded investigator support.
• Clinipace Worldwide: Clinipace is a mid-sized CRO/SMO hybrid providing clinical trial site services, patient recruitment, and biostatistics to biopharma sponsors. Comparable therapeutic-area breadth and site-network business model.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance12 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 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 Helios Clinical Research