Clinical Ink


Clinical ink is a global life science technology company dedicated to transforming the clinical trial experience through innovative data collection and management solutions. They focus on eSource, eCOA, eConsent, telehealth, digital biomarkers, and decentralized trial technologies, supporting faster, more efficient, and patient-centric clinical research.

Industries

clinical-trials
health-care
information-technology-dbca
mobile-devices
software

Nr. of Employees

medium (51-250)

Clinical Ink

Winston Salem, North Carolina, United States, North America


Products

Integrated web-based EDC/DDC/eCOA platform

A GCP-compliant, configurable web application combining electronic data capture, direct data capture/eSource workflows, and electronic clinical outcome assessments with API connectivity to third-party systems.

Digital biomarker and sensor analytics modules

Analytics modules to ingest sensor/wearable data, perform signal processing and feature engineering, and produce validated digital measures for clinical endpoints.

CGM/BGM data integration module

Module to capture, centralize, and analyze continuous and intermittent glucose monitoring data from commercially available devices to support diabetes and cardiometabolic trials.

Digital neurocognitive assessment platform

A modular platform for self-administered cognitive, behavioral, and physiological assessments used in clinical research, enabling remote and site-based testing with automated scoring and caregiver workflows.

AI-powered operations dashboard

Operational dashboard that applies AI to trial operations and device/eCOA monitoring to provide predictive alerts, site performance metrics, and centralized oversight for eCOA and connected-device trials.


Services

End-to-end eSource/DDC platform deployment

Implementation and operational support for real-time direct data capture solutions across site-based, home-based, and hybrid trial models.

eCOA implementation and complex assessment support

Configuration and deployment of electronic clinical outcome assessments, including complex neuropsychological batteries, multilingual translations, automated scoring, and rater review workflows.

Digital biomarker and analytics services

Data engineering, feature extraction, sensor fusion, machine learning model development, and validation services to derive and operationalize digital biomarkers.

Device logistics and patient support

Scaled device acquisition, provisioning, helpdesk support, and logistics for provisioned-device or BYOD studies to ensure device readiness and participant adherence.

Regulatory compliance and quality systems advisory

Support for meeting GCP, 21 CFR Part 11, GDPR, HIPAA and other regulatory requirements, implementation of eQMS, SDLC audit readiness, and training management.

Study build acceleration and platform configuration

Use of configurable activity designers and study-build tools to reduce study configuration timelines and enable subscription-based ‘self-service’ or managed builds.

Expertise Areas

  • Decentralized clinical trials (DCT) and hybrid study execution
  • Electronic Clinical Outcome Assessments (eCOA) and complex scale implementation
  • Direct data capture (eSource) and clinical data management
  • Digital biomarkers and sensor-derived endpoint development
  • Show More (4)

Key Technologies

  • Direct Data Capture (DDC) / eSource
  • Electronic Clinical Outcome Assessment (eCOA)
  • Electronic consent (eConsent)
  • BYOD and provisioned mobile device support
  • Show More (8)

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