TrialKit is a cloud-native, end-to-end eClinical platform developed by Crucial Data Solutions, designed to simplify and streamline data collection and study management in clinical trials. It supports all study models, including traditional, hybrid/decentralized, and fully remote trials, across all phases of research (preclinical to Phase 4) .
The platform is targeted at sponsors, Contract Research Organizations (CROs), and clinical sites . It features an intuitive drag-and-drop form builder that requires no programming, enabling quick study creation and the ability to make mid-study changes with zero downtime . This flexibility allows research teams to launch clinical trials in days, not weeks .
Key Features and Capabilities TrialKit offers a unified suite of tools, eliminating the need to stitch together disparate systems . These include:
- Electronic Data Capture (EDC), eSource, and Direct Data Capture (DDC) .
- Electronic Patient-Reported Outcomes (ePRO) and eClinical Outcome Assessments (eCOA) .
- eConsent for remote and in-person informed consent .
- TrialKit AI for advanced, real-time reporting and analytics, recognized with a 2024 SCDM Innovation Award .
- Electronic Trial Master File (eTMF), Randomization & Trial Supply Management (RTSM), and Payment Manager .
- Native Mobile Apps for iOS, Android, and Mac, making it the industry's only solution that can be used via web browser and native mobile app for full virtual trial enablement .
Compliance and Security The platform is built to ensure regulatory compliance and data integrity. It is compliant with FDA 21 CFR Part 11, HIPAA, and GDPR . Security features include immutable audit trails, role-based access control with over 250 configurable permissions, data encryption (AES 256/TLS 1.2 SSL), Single Sign-On (SSO), and biometric login (Touch ID/Face ID) .