Clinical Ink

What Clinical Ink does

Clinical Ink is a Winston-Salem, North Carolina-based privately held clinical trial technology company founded in 2006 that builds an eSource data capture platform used by pharmaceutical sponsors and contract research organizations (CROs) to conduct decentralized and hybrid clinical trials. The platform unifies Direct Data Capture (DDC), electronic Clinical Outcome Assessments (eCOA), eConsent, telehealth, sensors and wearables, and digital biomarkers within a single GCP- and FDA 21 CFR Part 11-compliant environment, supporting more than 4,000 assessments across 1,000+ completed studies.

The product portfolio centers on four technology pillars. GlucoseReady integrates continuous glucose monitor and automated insulin delivery data (including Tandem Diabetes Care systems) with eCOA for diabetes and weight management trials. SPUR, powered by the proprietary d.tells AI engine, provides behavioral diagnosis and personalized patient engagement to improve protocol adherence. Kaitality, launched in April 2026, is a digital tool for measuring drug adherence and functional weight loss outcomes for GLP-1 therapeutics. Therapeutic-area-specific solutions include the eLAS Suite for lupus studies and validated digital biomarkers (smartphone and smartwatch assessments) with peer-reviewed sensitivity to Parkinson's disease. The company holds ISO 13485:2016 certification for SaMD and reports zero critical findings in third-party SDLC audits for 2023 and 2024.

Clinical Ink generates revenue through enterprise SaaS subscriptions on multi-year contracts priced per study, sold primarily via a direct enterprise sales force targeting biopharmaceutical sponsors and global CROs, supplemented by a partner program that includes integrations with Cogstate, Mural Health, Teckro, eClinical Solutions, Perceptive Imaging, and a Snowflake data layer. The company has expanded beyond clinical trial sponsorship into a new Disease Management business unit focused on SaMD for FDA-approved therapies in cardiometabolic indications, anchored by the exclusive U.S. license to Observia's SPUR solution. Over the prior three years management reports bookings tripled, revenues quadrupled, and backlog grew 500%. The company employs 51-100 staff across offices in Winston-Salem, Horsham (PA), and Copenhagen, and in February 2026 announced a merger with BMclinical to broaden global clinical trial services.

Name

Clinical Ink

Legal name

Clinical Ink, Inc.

Website

https://clinicalink.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

251–500 employees

Short description

Clinical Ink provides a unified eSource platform for clinical trials — combining Direct Data Capture, eCOA, eConsent, sensors, and digital biomarkers — sold as enterprise SaaS to pharmaceutical sponsors and CROs, with a new disease management SaMD unit for cardiometabolic therapies.

Ownership category

akta.pro rank

Product category

Clinical Trial eSource Software

NAICS

Software Publishers (513210)

SIC

Services-Prepackaged Software (7372)

akta.pro primary industry

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

akta.pro secondary industries

eCOA/ePRO/eDiary & Patient-Facing Data Collection (HLACAOAB), Electronic Data Capture (EDC) Platforms (HLACAOAA), eConsent & Digital Identity for Trials (HLACAOAE)

Keywords

• Electronic data capture
• Clinical trial technology
• ECOA solutions
• Decentralized clinical trials
• Digital biomarkers

Headquarters

HQ city

Winston Salem

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. Clinical Trial Technology SaaS: Clinical ink provides eSource solutions including eCOA, DDC, eConsent, and related technologies to pharmaceutical sponsors and CROs for clinical trial data capture. Revenue is generated through software licensing and services for clinical studies across phases and therapeutic areas.
2. Disease Management Solutions: New business unit focused on disease management and health management products for patients receiving FDA-approved therapies. First product integrates SPUR eRetention tool with digital measurement into a SaMD solution for cardiometabolic therapeutic area.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels7 records

Core offering

Clinical Ink develops and licenses a unified eSource software ecosystem for clinical trials that integrates Direct Data Capture (DDC), electronic Clinical Outcome Assessments (eCOA), eConsent, telehealth, sensor/wearable data ingestion, and validated digital biomarkers into a single GCP-compliant platform. It sells this technology primarily to pharmaceutical sponsors and contract research organizations (CROs) to enable decentralized and traditional clinical trials, with adjacent disease management products such as GlucoseReady (diabetes), SPUR (adherence), eLAS (lupus), and Kaitality (GLP-1 adherence).

Differentiator

Problem solved

Functional benefit

Brands

• GlucoseReady: Connected device software platform for diabetes clinical trials that captures CGM/BGM data, eCOA, and patient insights.
• SPUR
• Kaitality
• BrainBaseline

Products and services

• GlucoseReady GlucoseReady is a connected-device software platform for diabetes clinical trials that integrates continuous glucose monitor (CGM) and blood glucose meter (BGM) data with eCOA and patient insights, delivering real-time glucose data to clinicians and integrating with Tandem Diabetes Care Automated Insulin Delivery systems. It is sold to pharmaceutical sponsors and CROs running diabetes and obesity clinical trials.
• SPUR Adherence Solution SPUR is a behavioral diagnostic and intervention tool that provides individualized behavioral diagnosis and intervention plans for patients by evaluating Social, Psychological, Usage, and Rational determinants of adherence, powered by Clinical Ink's proprietary d.tells AI engine. It is sold to sponsors, CROs, and (via SaMD) to patients on FDA-approved therapies in cardiometabolic disease.
• Clinical Ink eCOA Platform The Clinical Ink eCOA Platform is a configurable electronic Clinical Outcome Assessment platform with a WYSIWYG design interface enabling 10-day study build timelines, supporting PRO, ClinRO, and ePRO assessments. It is sold to pharmaceutical sponsors and CROs for clinical trials across therapeutic areas.
• Direct Data Capture (DDC) Direct Data Capture is Clinical Ink's technology for capturing and validating clinical trial data, documents, audio, images, and video in real time at the source. It is sold as part of the eSource ecosystem to sponsors and CROs running site-based and decentralized clinical trials.
• Clinical Ink eConsent Clinical Ink eConsent is the company's electronic informed consent offering, integrated within the eSource ecosystem to support decentralized and traditional clinical trials. It is sold to pharmaceutical sponsors and CROs as a component of the unified eSource platform.
• eLAS Suite The eLAS Suite is a lupus-specific clinical trial solution that provides Direct Data Capture purpose-built for lupus studies. It is sold to pharmaceutical sponsors and CROs conducting clinical research in lupus and adjacent immunology indications.
• Digital Biomarkers Solution Clinical Ink's Digital Biomarkers solution delivers validated measurements derived from sensors, wearables, and algorithms — including mobile assessments for cognition, mobility, and speech — to provide clinical-grade endpoints in real time. It is sold to pharmaceutical sponsors and research institutions for neurology, immunology, and other therapeutic areas.
• Clinical Ink Sensors & Wearables Integration Clinical Ink's Sensors & Wearables capability ingests and processes data from connected devices (e.g., CGMs, BGMs, smartwatches, mobile phones) into the eSource ecosystem, supporting sensor fusion across voice, mobility, GPS, and patient diaries. It is sold as part of the unified eSource platform to sponsors and CROs.
• Televisit Televisit is Clinical Ink's telehealth capability that supports remote site-patient interactions as part of decentralized clinical trial execution. It is sold to sponsors and CROs as a component of the unified eSource platform.
• Kaitality Kaitality is a first-in-class digital app for improving drug adherence for GLP-1 therapeutics while measuring functional weight loss outcomes including body composition and actigraphy. It is positioned as a standalone digital health tool for patients on GLP-1 obesity therapies, sold under Clinical Ink's disease management business.
• Decentralized Clinical Trials (DCT) Solution Clinical Ink's Decentralized Clinical Trials offering bundles DDC, eCOA, eConsent, Televisit, sensors/wearables, and digital biomarkers into a unified eSource platform that enables remote and hybrid trial execution. It is sold to pharmaceutical sponsors and CROs running decentralized studies.
• BrainBaseline BrainBaseline is a scientifically validated research platform for delivering mobile cognitive assessments in clinical trials and academic research. It is offered to pharmaceutical sponsors, academic institutions, and government research programs (e.g., Uniformed Services University EPICC study) for cognitive endpoint collection.

Quantifiable outcome

• Up to 85% cost reduction vs paper COA approaches
• +3 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration5 records

AI capability7 records

Feature8 records

Partnerships

Eight partnerships are on record, tiered core and supporting.

• Tandem Diabetes CarecoreTechnology or Integration · 22 December 2025Collaboration integrating Tandem's Automated Insulin Delivery systems (Tandem Mobi and t:slim X2) with Clinical ink's GlucoseReady platform. Enables real-time capture of insulin delivery data in Type 1 Diabetes clinical trials, improving data accuracy and reducing manual reporting.
• ObserviacoreStrategic or Co-development Partner · 13 November 2023Partnership to incorporate SPUR behavioral diagnostic tool into Clinical ink's technology suite. SPUR provides behavioral diagnosis and intervention plans evaluating Social, Psychological, Usage, and Rational determinants of adherence. Validated in 8 peer-reviewed publications and used in 100,000+ patients.
• TeckrosupportingTechnology or Integration · 31 May 2023Partnership combining Clinical ink's Direct Data Capture with Teckro's mobile app for improved site engagement. Provides immediate execution of inclusion/exclusion review, eConsent facilitation, and decentralized experience for study experts.
• Mural HealthcoreTechnology or Integration · 11 April 2023Strategic partnership adding Mural Link platform for patient payment and logistics capabilities. Enables participant stipend, reimbursement, and travel assistance to drive protocol compliance and retention.
• Digital ArtefactscoreStrategic or Co-development Partner · 8 November 2021Acquisition of Digital Artefacts (also referenced as subsidiary in privacy policy) to expand capabilities in clinical trial technology.
• eClinical SolutionssupportingTechnology or IntegrationSnowflake-based integration built and maintained by eClinical Solutions powers digital health initiatives with streamlined data ingestion across all sources.
• Perceptive ImagingsupportingTechnology or IntegrationPartnership with clinical trial imaging specialist providing therapeutically aligned imaging solutions for biopharmaceutical companies and CROs.
• CogstatecoreTechnology or IntegrationPartnership for cognitive assessment delivery via Clinical ink eCOA system. Includes instrument builds informed by Cogstate clinical science experts, integrated rater training and monitoring, and Cogstate digital assessments.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Medidata Solutions (Dassault Systèmes): Medidata's Rave platform is the dominant EDC/eCOA/CTMS suite used by large pharma sponsors. It is the most direct competitor to Clinical Ink's eSource ecosystem across decentralized and traditional clinical trials.
• Veeva Systems: Veeva Vault CTMS and Vault EDC compete with Clinical Ink in clinical operations and trial data management for large biopharma, with deep integration into sponsor TMF and quality workflows.
• Castor: Castor offers a configurable EDC and ePRO platform with strong DCT and patient engagement features, serving both academic and commercial sponsors as a direct competitor in mid-market eClinical.
• Oracle Clinical One: Oracle's unified Clinical One platform offers EDC, RTSM, supply management, and eCOA in a single environment — directly competing with Clinical Ink's unified eSource positioning for enterprise sponsor RFPs.
• Clario: Clario (formed from the merger of Bioclinica, ERT, and eResearch Technology) provides eCOA, imaging, cardiac safety, and respiratory solutions to clinical trials, making it one of the closest direct competitors to Clinical Ink in patient-facing data capture.
• Medable: Medable is a leading decentralized clinical trial (DCT) platform offering eCOA, eConsent, telehealth, and remote patient monitoring — directly competing with Clinical Ink's unified DCT and eSource platform.
• Medrio: Medrio provides cloud-based EDC, ePRO, and eConsent solutions for clinical trials, with a similar mid-market positioning and self-service study-build orientation as Clinical Ink.
• Signant Health: Signant Health (formed from CRF Health and Bracket) specializes in eCOA, eConsent, patient engagement, and rater training — overlapping directly with Clinical Ink's eCOA, eConsent, and patient engagement offerings.
• YPrime: YPrime provides eCOA, IRT, and clinical trial technology with a focus on configurable, patient-centric solutions — closely aligned with Clinical Ink's eCOA platform and study-build capabilities.

Broad incumbents

• IQVIA (EClinical / Digital Health): IQVIA offers a broad portfolio of eClinical, real-world evidence, and clinical operations solutions that overlap with Clinical Ink's eSource offerings, but as part of a much larger CRO-driven portfolio rather than a focused eCOA/EDC vendor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/@ClinicalInk1
• LinkedInlinkedin.com/company/clinical-ink
• Xx.com/ClinicalInk
• Facebookfacebook.com/clinicalinksuresource

Revenue estimate

Valuation estimate

Number of profiles

Profiles16 records

Subsidiaries1 record

Funding overview

Funding rounds7 records

Investors8 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Clinical Ink