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About Shilowiz

Shilowiz is a cloud-native, AI-powered platform designed to unify and streamline clinical trial operations by integrating electronic data capture (EDC), randomization and trial supply management (RTSM), clinical trial management systems (CTMS), and AI authoring tools into a single architecture. The platform connects sponsors, contract research organizations (CROs), clinical sites, and patients within a cohesive ecosystem, enabling real-time data synchronization and eliminating data silos that typically slow down drug development. The platform supports dynamic, zero-code configuration for mid-study changes, allowing rapid adjustments without re-validation or downtime, and features an API-first architecture with over 100 pre-built connectors for seamless enterprise integration and single sign-on (SSO) capabilities. Shilowiz includes AI-driven tools such as NAVON@site for site feasibility scoring and BINAH@ai for protocol and clinical study report (CSR) authoring, which automate compliance checks for regulatory guidelines like ICH, FDA, and EMA. It also offers specialized services in clinical data management, project management, and consulting to support end-to-end trial operations, ensuring data accuracy, regulatory readiness, and operational efficiency throughout the clinical development lifecycle.

Key features

  • Unified eClinical OS with real-time data synchronization
  • Next-gen EDC with zero-code mid-study changes
  • Intelligent RTSM for randomization and supply forecasting
  • Integrated CTMS and eTMF with SSO
  • AI protocol and CSR authoring with compliance checks
  • AI-driven site feasibility and selection
  • Dynamic configuration for rapid amendments
  • Enterprise integration via API-first architecture

Use cases

  • Accelerating clinical trial timelines through unified data management
  • Improving site selection accuracy with AI-powered feasibility scoring
  • Reducing protocol and CSR writing time with AI-driven drafting

Pros

  • Unified platform connecting EDC, RTSM, CTMS, and AI tools
  • AI-powered site feasibility scoring with up to 90% predictive accuracy
  • Zero-code mid-study changes with full audit trail maintenance
  • API-first architecture with 100+ pre-built connectors and SSO
  • Automated compliance checks for ICH, FDA, and EMA guidelines

Cons

  • No explicit pricing or free tier mentioned
  • Limited detail on supported languages beyond English
  • Requires integration with existing systems for full functionality

Frequently asked questions about Shilowiz

What is Shilowiz and what does it do?

Shilowiz is a unified eClinical operating system that integrates EDC, RTSM, CTMS, and AI authoring tools into a single cloud-native platform. It connects all stakeholders in clinical trials—sponsors, CROs, sites, and patients—while enabling real-time data synchronization, zero-code mid-study changes, and automated compliance checks for regulatory guidelines.

Who is Shilowiz designed for?

The platform is designed for pharma sponsors, contract research organizations (CROs), clinical sites, and patients involved in clinical trials. It supports organizations seeking to accelerate drug development, reduce operational costs, and improve data quality through automation and unified reporting.

How does Shilowiz integrate with existing systems?

Shilowiz offers an API-first architecture with over 100 pre-built connectors and supports single sign-on (SSO) to integrate seamlessly with existing enterprise systems such as EDC, RTSM, and CTMS platforms. This enables real-time data flow and eliminates the need for manual data entry or double handling.

What AI capabilities does Shilowiz provide?

Shilowiz includes AI-driven tools like NAVON@site for site feasibility scoring and BINAH@ai for protocol and CSR authoring. These tools automate tasks such as predictive site selection, protocol drafting, compliance validation, and risk insights, reducing manual effort and improving accuracy.

Does Shilowiz support regulatory compliance?

Yes, Shilowiz includes automated compliance checks aligned with ICH, FDA, and EMA guidelines, along with version control and audit trails. The platform is designed to ensure regulatory readiness throughout the clinical trial lifecycle.

How can I get started with Shilowiz?

Prospective users can schedule a demo or download an overview from the Shilowiz website to explore its features and capabilities. The platform offers tailored combinations of technology and services, and users can contact Shilowiz experts for a customized solution.

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