Clinical Ink

Clinical ink is a clinical trial technology company specializing in eSource solutions that connect data and operations across decentralized clinical trials. By integrating Direct Data Capture (DDC) technology, electronic Clinical Outcome Assessments (eCOA), eConsent, telehealth, neurocognitive testing, and digital biomarkers, Clinical ink drives data quality and operational excellence for sponsors, CROs, and researchers worldwide. The company's eSource ecosystem is designed to ingest all incoming data into a unified platform that supports analytics within and across studies, regardless of how or by whom the data was captured.

Over the past three years, Clinical ink has tripled its bookings, quadrupled revenues, and grown its backlog by 500%, reflecting strong momentum in the clinical research technology market. With more than 400 studies completed, over 800 assessments and instruments supported, 80+ BYOD studies, more than one million cognitive and behavioral measures collected, and partnerships with over 150 sponsors and CROs, Clinical ink has established a significant footprint in the industry.

eSource Technology Platform

• eCOA (Electronic Clinical Outcome Assessments): Minimizes complexity, accelerates study build timelines, and covers a wide range of therapeutic areas through fit-for-purpose assessments, including ePRO, eClinRo, and eObsRo formats.
• DDC Technology (Direct Data Capture): Enables real-time capture and validation of data, documents, audio, images, and video directly at the point of care or from the patient.
• eConsent: Simplifies and accelerates study startup, standardizes informed consent processes, and empowers patients throughout the trial.
• eLAS® Suite: A specialized solution designed to facilitate lupus clinical trials with straightforward, efficient, and reliable direct data capture.
• Mobile Devices: Delivers reach, efficiency, and data quality while increasing patient engagement through BYOD and provisioned device strategies.
• Televisit: Provides an easy, efficient, and holistic telehealth solution to improve remote monitoring and virtual site visits.
• Sensors & Wearables: Enriches clinical trial data collection through integration with a variety of sensor and wearable device solutions.
• Digital Biomarkers: Validates measurements from sensors and algorithms and delivers clinical data in real time to support clinical development decisions.

Specialized Products and Solutions

• GlucoseReady™ for Diabetes: A purpose-built solution that delivers continuous glucose monitoring (CGM) and blood glucose monitoring (BGM) data alongside eCOA and timely insights to clinicians in diabetes clinical trials, aligned with recent FDA guidance on CGM.
• GlucoseReady™ for Weight Management: Combines eCOA with timely clinical insights to support obesity and weight management trials.
• EDCXtra™: An additional data capture solution available within the Clinical ink platform ecosystem.
• Spur™: A patient engagement solution offered as part of the Clinical ink suite.
• TrialLens™: An analytics and operational visibility tool within the Clinical ink platform.
• Study Build in 10 Days: Clinical ink's innovative eCOA technology sets a new industry standard for speed, efficiency, and accuracy in the study build process, enabling study configuration in as few as ten days.
• COA vs. eCOA Cost Calculator: A personalized cost comparison tool that delivers study-specific savings estimates between paper COA and eCOA within 48 hours.

Therapeutic Area Expertise

• Neurology: Improves results for complex clinical trials involving central nervous system conditions, including movement disorders such as Parkinson's disease, where Clinical ink technology has demonstrated sensitivity to disease status and treatment response — work published in Nature Magazine.
• Infectious Disease: Speeds up trial timelines and improves data quality in infectious disease studies.
• Immunology: Leverages eSource tools, including the eLAS® Suite, to simplify and improve outcomes in complex lupus clinical trials.
• Oncology: Supports delivery on the Enhancing Oncology Model and improves patient adherence throughout the trial lifecycle.
• Diabetes: Offers a better patient experience and improved trial outcomes for diabetes research through the GlucoseReady™ platform.

Quality, Compliance, and Regulatory Standards

• Operates within a single GCP-compliant quality environment, adhering to GCP and 21 CFR Part 11 regulations.
• Commissioned proactive third-party SDLC audits against evolving EMA and FDA regulations in both 2023 and 2024, resulting in zero critical findings.
• Utilizes a master control electronic Quality Management System (eQMS) covering QMS, LMS, vendor management, and quality investigation management.
• Maintains 100% monthly Learning Management System (LMS) compliance across all employees.

Clinical ink serves a broad base of pharmaceutical sponsors and CROs seeking to advance decentralized and hybrid clinical trials through patient-centric technology. Guided by a vision to remain at the convergence of data, technology, and patient-centric research, Clinical ink continues to pioneer how digital tools and relationships transform patient outcomes and accelerate clinical discovery.