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Company description

Crucial Data Solutions (CDS) is the developer of TrialKit, an award-winning, validated, and fully customizable end-to-end eClinical platform purpose-built for clinical research teams. Founded in 2010 by a group of clinical technology experts, CDS set out to help drug and medical device companies get their products to market faster by creating an affordable, high-quality alternative to the high-cost, high-burden data collection and study management solutions that dominated the market. TrialKit enables sponsors and CROs to design, deploy, and manage studies in days — no programming required.

TrialKit serves a broad range of customers including medical device, diagnostics, biotech, and pharma sponsors, CROs, academic institutions, and patient advocacy groups. Notable customers include Verily (a subsidiary of Alphabet), Google, ICON plc, and Catalyst Clinical Research. The platform supports remote, hybrid/decentralized, and site-based clinical trials across all phases of development, and is accessible via web, iOS, Android, and native macOS desktop apps. With over 40,000 users globally, CDS averages fewer than 10 support requests per day, with an average response time of under 10 minutes.

Core Platform Modules

• Electronic Data Capture (EDC): A flexible, mobile-ready EDC system that makes it fast to set up studies, simple to update mid-study, and easy to maintain high data quality throughout the trial lifecycle.
• eSource & Direct Data Capture (DDC): Enables collection of source data directly at the point of care, online or offline, eliminating duplicate entry and reducing errors with real-time, site-friendly data capture.
• eCOA and ePRO: Allows patients to report outcomes from anywhere using a mobile-friendly design that supports both in-clinic and remote participation across all device types.
• eConsent: Provides secure, remote-ready consent workflows that simplify the process of informing and onboarding participants from any location while maintaining compliance.
• eTMF (Electronic Trial Master File): A secure, cloud-based document management system with real-time access, version control, and audit trails to maintain inspection readiness throughout the study.
• Randomization & Trial Supply Management (RTSM): A web and mobile module configurable to randomize and track subjects, drug supply, devices, and inventory throughout the course of a study.
• Payment Manager: Tracks and manages site payments accurately and on time, automating payment calculations, streamlining approvals, and reducing administrative burden without relying on spreadsheets or third-party tools.
• Standard Reporting and Dashboards: Built-in dashboards and configurable reports provide instant visibility into study performance, including enrollment, data quality, and query resolution — no programming required.
• Clinical Adjudication: Supports blinded adjudication processes with tools for event tracking, committee workflows, and secure documentation, all within a single platform.
• Medical Coding (TrialKit Coder): Integrates support for WHODrug and MedDRA coding to simplify medical term standardization, reduce errors, and improve data consistency.
• API Integrations: Features a proprietary machine-learning API that transforms unstructured EHR or other data into usable, structured data, streamlining workflows and improving data accuracy at the source.
• Televisits (TrialKit Engage): Built-in video conferencing enables remote assessments for decentralized clinical trials, improving patient accessibility and retention without switching platforms.
• PACS Imaging (TrialKit PACS): Allows users to upload, store, and view DICOM images directly within TrialKit, eliminating the need for a separate imaging platform while maintaining secure, compliant access.
• AI Analytics (TrialKit AI): Built-in artificial intelligence surfaces trends and risks in real time, enabling teams to respond proactively before small issues escalate into major delays.

Key Platform Capabilities

• Unified, end-to-end platform covering every function from study startup to closeout — EDC, ePRO, eConsent, reporting, patient engagement, and more — in a single system with no siloed logins.
• The industry's only fully native mobile app, providing true access and flexibility for remote teams and participants on any device.
• No-code study configuration allowing sponsors and CROs to customize and launch studies quickly without developer involvement.
• Real-time performance monitoring and AI-powered analytics to identify and address issues proactively.
• Open architecture with API integrations designed to complement and connect with existing systems rather than replace them.
• Cloud-based infrastructure with a flexible subscription model that scales from single studies to large, complex global pipelines.

Deployment, Compliance, and Company Details

• TrialKit is a fully validated, cloud-based platform built on an open architecture, supporting compliance requirements across clinical research.
• The platform is available via web browser, iOS app, Android app, and native macOS desktop application, enabling access from virtually any location or device.
• Crucial Data Solutions is privately held and self-funded, allowing the company to continuously improve and expand its products while maintaining an affordable pricing model — a rarity in the eClinical industry.
• CDS is exclusively focused on clinical technology and does not operate in other industries or services, enabling a high standard of product quality and customer support.
• The company operates a customer-first model, with a lean support operation serving 40,000+ global users and responding to inquiries in under 10 minutes on average.

Crucial Data Solutions remains focused on its founding mission: to help customers reclaim control of their clinical operations and advance patient health and quality of life through advanced, affordable clinical technology. TrialKit is designed for sponsors and CROs of all sizes who need a fast, flexible, and fully integrated platform that works wherever research happens.

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Software attributed to Crucial Data Solutions

• TrialKit PlatformView
• EDCView
• eSource & Direct Data CaptureView
• eCOA/ePROView
• eConsentView
• eTMFView
• TrialKit Payment ManagerView
• TrialKit AIView
• TrialKit Standard Reporting & DashboardsView
• TrialKit Clinical AdjudicationView
• TrialKit CoderView
• TrialKit API IntegrationsView
• TrialKit EngageView
• TrialKit Remote Patient Monitoring & Wearable IntegrationsView
• TrialKit PACSView

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