What Risklick does

Risklick AG is a Swiss AI company founded in 2019 and headquartered in Bern that develops Protocol AI, an enterprise SaaS platform for designing and authoring clinical trial protocols and study plans. The platform is powered by a proprietary database of over 800,000 clinical trials linked to publications, regulatory approvals, and safety data, and uses customized generative AI to produce protocols in ICH M11 and USDM-standard digital formats with export options for Word, Excel, or JSON. It integrates directly with EDC and eTMF systems and follows a structured three-step workflow (Explore, Design, Develop) for evidence-based study design optimization.

The company targets pharmaceutical sponsors as its primary segment and life sciences organizations (CROs and biotech companies) as a secondary segment, selling through enterprise direct sales with "Request a Demo" CTAs and annual subscription plans with tiered user roles (Organization Admin, Creator, Reviewer, Reader). Pricing is quote-based and not publicly disclosed. A secondary product, Deduklick, offers AI-powered automated data deduplication as an add-on. Strategic distribution is augmented by a January 2026 partnership with Citeline, and the company holds ISO 27001:2022 certification and GDPR compliance posture.

Risklick is privately held, backed by Debiopharm Innovation Fund since April 2024, and has received the Innosuisse Certificate recognizing growth readiness in the second half of 2025. Stated outcome metrics include a 50% reduction in protocol development time, 20% reduction in protocol amendments, and 40% reduction in protocol implementation time, though these figures are company-reported and not independently validated in the available data.

Name

Risklick

Legal name

Risklick AG

Website

https://risklick.ch

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

11–50 employees

Short description

Risklick AG is a Swiss AI company building Protocol AI, an enterprise SaaS platform that uses generative AI and an 800,000-trial database to accelerate clinical trial protocol design and authoring for pharmaceutical sponsors and life sciences companies.

Ownership category

akta.pro rank

Product category

Clinical Trial Protocol Development Software

NAICS

Software Publishers (5132)

SIC

Services-Prepackaged Software (7372)

akta.pro primary industry

AI/ML Platforms for Drug Discovery & Experiment Optimization (HLAGAJAO)

akta.pro secondary industries

Randomization & Trial Supply Management (RTSM/IRT/IVRS/IWRS) (HLACAOAC), Site & Investigator Platforms (Site Payments, Feasibility, Activation) (HLACAOAJ)

Keywords

• Clinical trial protocols
• AI protocol authoring
• Clinical trial design
• Protocol optimization software
• Evidence-based study design

Headquarters

HQ city

Bern

HQ country

Switzerland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. Protocol AI SaaS Subscription: Subscription-based access to the Protocol AI software platform delivered as a SaaS solution. Access is tiered by user roles (Organization Admin, Creator, Reviewer, Reader) and governed by subscription plans specifying usage limits, feature access, and contract terms. Fees are due in advance and non-refundable upon termination.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

Risklick develops and sells Protocol AI, an end-to-end SaaS platform that uses customized generative AI and a proprietary database of over 800,000 clinical trials to enable pharmaceutical sponsors and life sciences companies to design, optimize, and generate clinical trial protocols and study plans. The platform supports a three-step Explore-Design-Develop workflow, produces ICH M11/USDM-standard digital protocols, and integrates with EDC and eTMF systems, reducing protocol development time by 50%, amendments by 20%, and implementation time by 40%.

Product overview

Risklick offers Protocol AI as its core flagship platform—an end-to-end AI solution for clinical trial protocol development—and maintains a separate product called Deduklick for automated data deduplication. Protocol AI is a unified platform that combines evidence-based study design exploration, multi-scenario optimization, and AI-powered protocol generation, all supported by a proprietary database of over 800,000 clinical trials. The platform supports digital protocol exports in ICH M11 and USDM standards, integrates with EDC and eTMF systems, and aims to reduce clinical development timelines significantly.

Differentiator

Problem solved

Functional benefit

Brands

• Protocol AI: AI-powered end-to-end software solution for designing and developing clinical trial protocols and study plans rapidly and efficiently.
• Deduklick

Products and services

• Protocol AI End-to-end AI-powered SaaS platform for designing and developing high-quality clinical trial protocols and study plans rapidly. It runs a 3-step Explore-Design-Develop workflow over a proprietary database of 800,000+ clinical trials, uses customized generative AI to author protocols, and exports ICH M11 and USDM-standard digital protocols with integration to EDC and eTMF systems. Sold via subscription to pharmaceutical sponsors and life sciences organizations.
• Deduklick Transparent, fully automated AI-powered deduplication solution for removing duplicate records. Claimed to be 100x faster, 10x cheaper, and 100% precise compared to manual deduplication. Offered as a separate product alongside Protocol AI.

Quantifiable outcome

• 50% reduction in protocol and study plan development time
• +3 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

AI capability6 records

Feature6 records

Partnerships

Six partnerships are on record, tiered core and minor.

• CitelinecoreStrategic or Co-development Partner · 13 January 2026Citeline, a clinical solutions provider for the life sciences industry, partnered with Risklick to create an integrated AI-driven solution spanning protocol design, operationalization, and regulatory disclosure. The partnership addresses rising protocol amendment costs (each ranging from $140,000 to $500,000) by combining Risklick's protocol design expertise with Citeline's data and AI capabilities for evidence-based endpoint optimization. The combined solution enables sponsors to move from concept to execution faster and improve enrollment outcomes.
• be-advancedminorOthersListed as a partner logo on the Risklick website under the 'Partners' section, indicating some form of collaborative relationship supporting Risklick's AI-driven clinical trial protocol development solutions.
• SiteminselminorOthersListed as a partner logo on the Risklick website under the 'Partners' section, indicating some form of collaborative relationship supporting Risklick's AI-driven clinical trial protocol development solutions.
• University of Geneva (UNIGE)minorOthersListed as a partner logo on the Risklick website under the 'Partners' section, indicating collaboration with academia supporting Risklick's AI-driven clinical trial protocol development.
• University of Bern (UNIBE)minorOthersListed as a partner logo on the Risklick website under the 'Partners' section, indicating collaboration with academia supporting Risklick's AI-driven clinical trial protocol development.
• Debio (Swiss Biotech Association)minorOthersListed as a partner logo on the Risklick website under the 'Partners' section. Debio is the Swiss Biotech Association, indicating Risklick's membership and participation in the Swiss biotech ecosystem.

Scale indicators3 records

Recent moves5 records

Expansion highlights6 records

Emerging players

• 4G Clinical: 4G Clinical provides randomization and trial supply management (RTSM/IRT) and related clinical trial technology, serving the same pharma and CRO buyers that Risklick targets for protocol design workflows.
• Saama Technologies: Saama provides AI-driven clinical development analytics and automation for pharma, including protocol design and patient journey insights. It overlaps with Risklick's evidence-based protocol optimization focus, targeting the same pharma sponsors.
• Deep 6 AI: Deep 6 AI uses AI on structured and unstructured clinical data to accelerate trial feasibility, patient recruitment, and protocol design. It is an emerging player targeting adjacent parts of the clinical trial workflow that Risklick also addresses.
• Medable: Medable is a decentralized clinical trial platform that incorporates AI-enabled study design and protocol authoring workflows for sponsors and CROs. It targets a similar customer base as Risklick with overlapping protocol automation capabilities.
• Y Prime: Y Prime provides eClinical solutions including EDC, IRT, and increasingly AI-enabled protocol authoring tools for pharma and biotech sponsors. It is a closer-sized competitor to Risklick in clinical trial design automation.

Broad incumbents

• Veeva Systems: Veeva is the dominant cloud software provider for life sciences, including Veeva Vault EDC and CTMS. It targets the same pharma sponsors as Risklick and could build or acquire native AI protocol-design capabilities, making it the primary incumbent competitive threat to Protocol AI.
• Medidata Solutions (Dassault Systèmes): Medidata's Rave platform is a leading EDC and clinical trial technology suite used by global pharma sponsors. It serves the same protocol authoring and trial design workflows that Risklick targets and has been actively adding AI features across its clinical cloud.
• Oracle Health Clinical One: Oracle's Clinical One platform unifies EDC, RTSM, and trial design into a single cloud platform. As a broader clinical trials incumbent with deep enterprise pharma relationships, it competes for the protocol authoring and study design workflow that Protocol AI addresses.
• IQVIA: IQVIA is the world's largest CRO and a major clinical technology provider, with AI-enabled trial design and real-world data assets. It competes broadly with Risklick for pharma sponsor spend on protocol design and clinical development optimization.

Direct peers

• Castor: Castor offers an AI-enabled EDC and eClinical platform used by sponsors and CROs for clinical trial design and data capture. It directly overlaps Risklick's protocol and trial design automation use cases, particularly for mid-sized sponsors and academic trials.

Market position

Strengths2 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/risklick
• Xx.com/risklick

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds1 record

Investors1 record

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 Risklick