TrialKit Platform

TrialKit, developed by Crucial Data Solutions (CDS), is a compliant, cloud-based, end-to-end eClinical platform designed to help research teams run complex clinical trials and large-scale registry studies without excessive cost or lengthy setup times. Built for sponsors, CROs, site personnel, and study participants alike, TrialKit's low-code/no-code, drag-and-drop environment enables teams to launch studies in days rather than months — with no custom coding or database migrations required.

The platform supports all study models, therapeutic areas, and levels of complexity — from preclinical research through Phase 1–3 trials, post-market evaluation, and Phase 4 registry studies. Accessible via both mobile and web applications on smartphones, tablets, and desktop computers, TrialKit gives busy research teams the flexibility to manage studies from anywhere, on any device.

Comprehensive Module Suite

• Modules include EDC, eSource, eCOA/ePRO, eConsent, eTMF, RTSM, Medical Coding, Virtual Visits, and PACS
• Proprietary AI models power study validation and advanced reporting and analytics
• All modules operate on both mobile and web applications across smartphone, tablet, and desktop
• Add or remove modules according to the specific needs of each study
• Make mid-study changes on the fly with no downtime
• Reuse existing data, validations, configurations, and forms to accelerate successive study builds

Rapid Study Build and Onboarding

• Drag-and-drop environment allows teams to get started in less than one day and become TrialKit Administrator-certified within a week
• AI-driven validation capabilities enable complete end-user testing in minutes rather than days
• Role-based testing supports a system designed for quality
• Reuse CRFs, stacked edit checks, and conditional actions to reduce development time for each successive study
• Ability to operate in 5G and 6G platforms for decentralized clinical trials

Data Security and Protection

• Over 250 configurable role-based access options for site personnel, sponsors, CROs, study teams, and study participants
• Software and data center comply with SOC Type 2, Privacy Shield EU-US, and HiTrust standards
• Compatible with all modern web browsers and mobile operating systems
• Disaster recovery, data backups, redundancy, and fail-over features guarantee 99.7% uptime
• Data corruption protection and enhanced data verification via blockchain APIs
• ALCOA+ data integrity maintained via blockchain APIs

Regulatory Compliance

• Compliant with 21 CFR Part 11, GDPR, HIPAA, EMEA Annex 11, ICH Q9, ISO 9001:2015, and ISO/IEC 27001:2013
• Transparent pricing structure removes high costs typically associated with launching and running studies

Patient- and Site-Centric Features

• BYOD approach supported — available as a downloadable mobile app for iOS, Android, and Mac devices, eliminating the need to provision devices to sites or participants
• Biometric login via Touch ID and Face ID on compatible smart devices, with two-factor authentication support
• Multilingual interface currently available in 16 languages, with end-user-defined settings
• Single sign-on (SSO) provides access to an unlimited number of studies in one place
• Automatic upload of images, video, and audio recordings directly from a smartphone or tablet into TrialKit

Infrastructure and Hosting

• Centralized, cloud-based platform hosted on Amazon Web Services (AWS) for compliant, secure, and reliable hosting
• Strategically located worldwide data centers to address geographic data privacy requirements
• Ability to synchronize multiple clouds across geographic regions according to study or program needs
• Run multiple clouds with single sign-on (SSO)
• White/private label option: CDS can set up, configure, and deploy a branded version of the TrialKit mobile app available on the App Store and Google Play
• Private cloud option available for a customized, dedicated hosting environment within the CDS/AWS ecosystem

Integration Capabilities

• Fully documented, modern RESTful API enables integration of data to and from any external system or database, including EDC, eTMF, CTMS, IRT, and imaging systems
• Integration with third-party data sources including wearable devices, electronic health records, and any Bluetooth-enabled device such as implants and sensors
• Over 1,000 unique API calls available

Support and Training

• 24/7 help desk support available via email and online request
• Live technical support available during business hours (8 a.m.–5 p.m. EST)
• Live, hands-on study setup and configuration support during the first 90 days of any new implementation
• Extensive library of self-service training tools including a knowledge base with AI-powered search, videos, and training wizards

TrialKit is deployed as a truly SaaS, cloud-based solution hosted on AWS, with global data center coverage to meet regional data privacy requirements. Its transparent pricing model, flexible module structure, and broad compliance certifications make it well suited for research organizations of all sizes seeking a cost-effective, scalable eClinical platform.