What Ethical does

Ethical GmbH is a Basel, Switzerland-based eClinical SaaS vendor specializing in clinical committee management software for the pharmaceutical and biotech research market. The company operates four cloud-based, AI-marketed platforms — eAdjudication® (endpoint adjudication committees), eDSMB® (Data Safety Monitoring Boards and DMCs), eDeviation® (protocol deviation committees), and eReconciliation® (SAE/safety data reconciliation) — each configurable to a study charter and supported by a full GAMP 5 validation documentation package. Underlying architecture is GxP-validated and compliant with FDA 21 CFR Part 11, EU GMP Annex 11, ISO/IEC 27001, and GDPR, with Guardtime KSI Blockchain signatures applied to audit trails for tamper-evident time-stamping. The product surfaces are tightly integrated, share a common configuration engine, and are offered as standalone SaaS or via the CRO-Safe Partnership Program channel motion.

Ethical serves three primary customer segments: pharmaceutical and biotech sponsors (including multinationals), Contract Research Organizations (CROs) — both as direct users and as channel resellers — and Academic Research Organizations (AROs) such as Stanford SCCR and Uppsala CRC. The revenue model combines annual SaaS subscriptions (priced by support level and study complexity, not publicly disclosed) with professional services for deployment, validation, and ongoing support. Go-to-market is sales-led direct enterprise sales supplemented by the CRO channel program, with named enterprise users including Actelion. The company is privately held by Italian parent GM Servizi srl, has operated since 1994, and remains small at 11-50 employees.

The company's strategic posture in the observed period is one of incremental platform deepening rather than aggressive expansion: its most material recent moves are the December 2025 partnership with Voiant, the Medidata Rave EDC integration, and continued investment in regulatory certifications and the CRO channel. It does not present a venture-funded growth profile; rather, it operates as a capital-efficient, niche specialist compounding on regulatory compliance, accumulated clinical workflow expertise, and high switching costs within regulated buyer environments.

Name

Ethical

Legal name

Ethical GmbH

Website

https://ethicalclinical.com

Company type

Private

Founded year

1994

Operating status

Operating

Headcount range

11–50 employees

Short description

Ethical GmbH is a Basel-based eClinical SaaS provider of cloud-based clinical committee management software — endpoint adjudication, DSMB, protocol deviation, and SAE reconciliation — sold to pharma sponsors, CROs, and academic research organizations under GxP-compliant, annual subscription contracts.

Ownership category

akta.pro rank

Product category

Clinical Trial Management Software

NAICS

Software Publishers (5132)

SIC

Services-Prepackaged Software (7372)

akta.pro primary industry

Regulatory Submissions & Clinical Content Management (eCTD/Publishing) (HLACAOAN)

akta.pro secondary industries

Electronic Data Capture (EDC) Platforms (HLACAOAA), Safety Database Operations & Hosting (Argus/ARISg/Oracle) (HLAGALAB)

Keywords

• Clinical trial software
• Endpoint adjudication software
• Clinical committee management
• Safety data reconciliation
• Protocol deviation tracking

Headquarters

HQ city

Basel

HQ country

Switzerland

HQ region

Europe

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. Software Subscriptions (SaaS): Flexible pricing model for SaaS software subscriptions covering eAdjudication, eDSMB, eDeviation, and eReconciliation platforms. Pricing aligns to chosen level of support and can be customized for CRO or sponsor needs.
2. Professional Services: Customized support services including technical assistance for software deployment, staff training, first and/or second level support, and ongoing tailored assistance from dedicated experts.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

Ethical sells a portfolio of cloud-based SaaS platforms that help pharmaceutical sponsors, CROs, and academic research organizations run independent clinical committees during clinical trials. Its four core products—eAdjudication®, eDSMB®, eDeviation®, and eReconciliation®—manage endpoint adjudication, Data and Safety Monitoring Boards, protocol deviation committees, and SAE safety data reconciliation, with built-in AI-powered automation, KSI Blockchain audit trails, and GxP/GAMP 5 validation.

Product overview

Ethical offers a portfolio of AI-powered clinical committee software solutions for the pharmaceutical and biotech industry. The product suite consists of four core SaaS platforms: eAdjudication® for independent Clinical Adjudication Committees, eDSMB® for Data and Safety Monitoring Boards, eDeviation® for Protocol Deviation Committees, and eReconciliation® for SAE (Serious Adverse Event) Reconciliation. These products share a common flexible, cloud-based architecture that can be configured to match any study charter and support GxP validation requirements. The software is offered both as standalone solutions and through the CRO-Safe Partnership Program for CRO integration.

Differentiator

Problem solved

Functional benefit

Brands

• eAdjudication®: Cloud-based platform for independent clinical endpoint adjudication
• eDSMB®
• eDeviation®
• eReconciliation®

Products and services

• eAdjudication® Flexible SaaS software with customized support that helps pharmaceutical sponsors, AROs, and CROs manage endpoint adjudication processes for independent Clinical Adjudication Committees (CEC), covering training, event management, submission, and queries with full audit trail and GxP validation.
• eDSMB® SaaS platform that helps sponsors, AROs, and CROs run independent Data and Safety Monitoring Boards and Data Monitoring Committees, with flexible customization and expert support services for independent safety reviews during clinical trials.
• eDeviation® SaaS platform that supports Protocol Deviation Committees for sponsors, AROs, and CROs, enabling them to track and adjudicate protocol violations, deviations, and exceptions across a clinical study.
• eReconciliation® Dedicated SaaS platform for SAE (Serious Adverse Event) reconciliation, equipped with automation features, smart tools, and task management capabilities that allow data management, clinical, and safety teams to perform reconciliation throughout study duration with full audit trail for regulatory inspections.

Quantifiable outcome

• Reduces scan, signature, and upload times compared to manual review
• +1 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

AI capability2 records

Feature6 records

Partnerships

One partnership is on record.

• VoiantcoreStrategic or Co-development Partner · 1 December 2025Voiant partnered with Ethical to deploy eAdjudication® and eDSMB® software. Voiant also joined the Ethical-CRO Safe Partnership Program. The partnership aims to enhance clinical trial management and expertise by combining Voiant's clinical capabilities with Ethical's software technology.

Scale indicators3 records

Expansion highlights5 records

Direct peers

• Clario: Clario (formed from ERT and Bioclinica merger) provides endpoint adjudication, EDC, and imaging solutions for clinical trials. It directly competes with Ethical in the committee management and adjudication space serving large pharma sponsors.
• Signant Health: Signant Health offers eClinical solutions including EDC, eCOA, and clinical technology for trial management. It competes with Ethical in providing specialized software platforms for clinical trial operations and endpoint data.
• Advarra: Advarra provides clinical research technology including IRB, IBC, and eRegulatory solutions, with overlapping clinical research workflow software that competes with Ethical's committee management offerings.
• ArisGlobal: ArisGlobal offers pharmacovigilance and safety databases (LifeSphere) that overlap with Ethical's eReconciliation product for SAE reconciliation and safety data management.
• Anju Software: Anju Software provides a comprehensive eClinical suite including CTMS, EDC, and safety solutions for life sciences. It competes with Ethical across multiple clinical research workflow categories.

Broad incumbents

• Medidata (Dassault Systèmes): Medidata offers the Rave EDC platform and broader clinical cloud suite. Ethical integrates with Medidata Rave today, but Medidata's scale and breadth could enable it to encroach on committee management workflows.
• Veeva Systems: Veeva provides Vault CTMS, Vault EDC, and quality/regulatory suites for life sciences. Its broad platform presence and enterprise scale make it a strategic adjacent incumbent to Ethical's specialized offerings.
• Oracle Health Sciences: Oracle's Health Sciences suite includes clinical trial and pharmacovigilance applications. As a broad incumbent, it competes indirectly with Ethical's committee management and SAE reconciliation capabilities.

Emerging players

• WCG (WIRB-Copernicus Group): WCG provides IRB, IBC, and clinical research services with growing technology offerings for trial operations. It is a comparable peer given its focus on clinical committee workflows and sponsor services.
• Voiant: Voiant is a clinical research services firm that recently partnered with Ethical to deploy eAdjudication and eDSMB. It is comparable as both a CRO customer/partner and a provider of adjudication-related clinical services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/ethical-gmbh
• Xx.com/Ethicalgmbh

Compliance6 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 Ethical