Enlighten Clinical Solutions

What Enlighten Clinical Solutions does

Enlighten Clinical Solutions is a private, founder-led clinical technology company headquartered in Atlanta, Georgia, founded in 2016 by CEO Jim Harris. The company sells a unified, cloud-based clinical trial platform that integrates Electronic Data Capture (EDC), electronic Trial Master File (eTMF), and — following its May 2026 launch — a Clinical Trial Management System (CTMS) module within a single secure environment. The platform also offers modular add-ons including Interactive Response Technology (IRT), electronic Patient-Reported Outcomes (ePRO), eConsent, trial supply management, imaging and reading center workflows, and real-time dashboards, with built-in support for FDA 21 CFR Part 11, HIPAA, GDPR, and SOC 2 Type II controls.

Name

Enlighten Clinical Solutions

Legal name

Enlighten Clinical Solutions

Website

https://enlightenclinical.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

1–10 employees

Short description

Enlighten Clinical Solutions provides a unified cloud-based EDC, eTMF, and CTMS platform for clinical trial sponsors, CROs, and research sites, with a focus on ophthalmology and modular compliance-aligned workflows.

Ownership category

akta.pro rank

Product category

Clinical Trial Technology (eClinical Solutions)

NAICS

Computer Systems Design and Related Services (54151)

SIC

Services-Prepackaged Software (7372)

akta.pro industry

PRIMARYHLACAOAA

Electronic Data Capture (EDC) Platforms

Healthcare & Life Sciences/Digital Health & Health IT/Clinical Trials & Research Informatics (eCOA/ePRO/EDC)

SECONDARYHLACAOAD

Clinical Trial Management Systems (CTMS)

Healthcare & Life Sciences/Digital Health & Health IT/Clinical Trials & Research Informatics (eCOA/ePRO/EDC)

SECONDARYHLACAOAB

eCOA/ePRO/eDiary & Patient-Facing Data Collection

Healthcare & Life Sciences/Digital Health & Health IT/Clinical Trials & Research Informatics (eCOA/ePRO/EDC)

SECONDARYHLACAOAC

Randomization & Trial Supply Management (RTSM/IRT/IVRS/IWRS)

Healthcare & Life Sciences/Digital Health & Health IT/Clinical Trials & Research Informatics (eCOA/ePRO/EDC)

SECONDARYHLAGAJAM

Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Life Science Software & Informatics (LIMS/ELN/Bioinformatics)

Keywords

• Clinical trial software
• Electronic data capture
• Clinical trial management
• ETMF solutions
• Ophthalmology research

Headquarters

HQ city

Atlanta

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. SaaS Platform Subscription: Cloud-based clinical trial platform delivered as subscription service with study-specific configuration. Pricing based on study complexity, number of sites, and modules utilized.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

Enlighten Clinical Solutions provides a cloud-based, unified clinical trial technology platform that integrates Electronic Data Capture (EDC), electronic Trial Master File (eTMF), and Clinical Trial Management System (CTMS) modules within a single compliant environment for sponsors, CROs, and research sites. The platform adds optional capabilities such as IRT, ePRO, E-Consent, trial supply management, imaging and reading center workflows, real-time dashboards, and role-based access. It is sold on a SaaS subscription basis, with particular specialization in ophthalmology trials alongside adaptability to cardiology, oncology, neurology, and other therapeutic areas.

Product overview

Enlighten Clinical Solutions offers a unified cloud-based clinical technology platform designed for modern clinical research, combining three core integrated modules—Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), and Clinical Trial Management System (CTMS, available Q2 2026)—within a single connected environment. The platform provides a modular architecture with additional capabilities including IRT (Interactive Randomization Technology), ePRO (Electronic Patient-Reported Outcomes), E-Consent, Trial Supply Management, Imaging and Reading Center Integration, Real-Time Dashboards, and Role-Based Access Controls. Built to support sponsors, CROs, and research sites, the platform emphasizes data integrity, regulatory compliance (FDA, HIPAA, GDPR), and operational efficiency across the clinical trial lifecycle, with particular specialization in ophthalmology research.

Differentiator

Problem solved

Functional benefit

Products and services

• Enlighten Clinical Platform (Unified Clinical Trial Platform) Cloud-based, unified clinical trial technology platform integrating EDC, eTMF, and CTMS capabilities within a single compliant environment, sold to sponsors, CROs, and research sites as a SaaS subscription.
• Electronic Data Capture (EDC) Centralizes clinical trial data collection with a secure, configurable EDC designed for speed, accuracy, and regulatory compliance, featuring flexible CRF design, validation logic, real-time oversight, and high-performance data management.
• Electronic Trial Master File (eTMF) Maintains inspection-ready clinical trial documentation with structured workflows, real-time completeness tracking, controlled access, centralized document control, automated filing, and audit readiness within the unified clinical trial platform.
• Clinical Trial Management System (CTMS) Coordinates study operations, milestones, and oversight within a centralized CTMS designed to integrate seamlessly with EDC and eTMF workflows, supporting site and study management, milestone tracking, study progress oversight, source document upload and review, role-based access, dashboards, metrics, and alerts.

Quantifiable outcome

• Reduces operational complexity and system fragmentation
• +3 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability4 records

Feature9 records

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Emerging players

• RealTime Software Solutions: RealTime provides CTMS and site management software primarily for research sites and sponsors. It overlaps with Enlighten's site-focused CTMS capabilities and represents a similarly scaled competitor in the mid-market segment.

Broad incumbents

• Veeva Vault EDC / Vault CTMS: Veeva's Vault clinical suite is the most entrenched integrated EDC + CTMS + eTMF platform in the industry, competing directly with Enlighten's unified clinical trial platform positioning.
• Veeva Systems: Veeva's Vault EDC, Vault CTMS, and Vault eTMF are direct competitors to Enlighten's unified platform. Veeva serves the largest life sciences customer base globally with deeply validated modules and is the enterprise default for many sponsors and CROs.
• ArisGlobal: ArisGlobal's LifeSphere platform includes CTMS, EDC, eTMF, and safety solutions serving life sciences sponsors and CROs. It competes with Enlighten across the integrated clinical trial technology stack.
• Oracle Clinical One: Oracle's Clinical One platform unifies EDC, RTSM, and clinical trial operations within a single environment. As a direct competitor to Enlighten's unified architecture, it leverages Oracle's enterprise footprint and large sponsor relationships.
• Medidata Solutions (Dassault Systèmes): Medidata's Rave EDC, Rave CTMS, and broader clinical cloud platform is the market-leading integrated clinical trial technology stack. It directly competes with Enlighten's combined EDC/eTMF/CTMS offering and dominates large pharma sponsor deployments.
• Clario (formerly Bioclinica): Clario offers EDC, CTMS, eCOA, and imaging workflow solutions, including a strong reading center capability that overlaps with Enlighten's ophthalmology imaging integration. It serves large pharma and CRO clients globally.

Direct peers

• Castor: Castor is a direct EDC competitor that also offers ePRO, eConsent, RTSM, and decentralized trial capabilities. Like Enlighten, Castor targets sponsors and CROs seeking a unified, configurable platform with strong user experience.
• Medrio: Medrio provides cloud-based EDC, eCOA/ePRO, eConsent, and CTMS solutions for clinical research. It overlaps heavily with Enlighten's product portfolio and similarly targets mid-sized sponsors and CROs.
• Clinical Ink: Clinical Ink specializes in eCOA/ePRO, eConsent, and patient-centric clinical trial technology. It is a direct peer in the patient-facing data collection and clinical trial platform space, particularly relevant to Enlighten's ePRO and eConsent modules.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/enlighten-clinical-solutions

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 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 Enlighten Clinical Solutions