ClinVigilant

Clinvigilant (marketed under the eClinicalSuite brand) develops an integrated eClinical platform designed to support Phase I through Phase IV clinical trials. The platform brings together Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), and Patient Engagement tools — including ePRO and eConsent — into a single cloud-based environment. The company serves sponsors, CROs, and clinical sites, with a stated focus on configurability, ease of use, and cost-effectiveness.

Clinvigilant reports over 15 years of industry experience, a user base of more than 20,000 users, 300+ studies conducted across 30+ countries, and a 98% satisfaction rate. The platform is built to be regulatory compliant and is supported by in-house subject matter experts.

Core Products

• Electronic Data Capture (EDC): A configurable, cloud-based EDC system that supports the creation of electronic Case Report Forms (eCRFs) from paper CRFs without requiring programming. It includes inbuilt CDISC–CDASH based libraries to accelerate study setup and management.
• Electronic Trial Master File (eTMF): Connects sponsors, CROs, and sites through automated processes for creating, managing, and tracking the Trial Master File. Supports integration with other platforms and enables real-time monitoring of multiple sites.
• Patient Engagement Platform: Covers study recruitment, screening, consent, visit management, and direct data collection. Designed for decentralized and hybrid research projects, with an emphasis on compliant, site-friendly, and patient-centric experiences.

Platform Capabilities and Characteristics

• All modules are integrated within a single platform, allowing tracking of the patient journey end-to-end.
• Study setup is described as requiring no programming, enabling users to build a study in hours.
• The platform is cloud-based and designed to be user-friendly and accessible to a broad range of users.
• CDISC–CDASH library support is built in to support standardized data collection.
• Supports both decentralized and hybrid clinical trial models through the Patient Engagement module.

Compliance, Deployment, and Scale

• The platform is described as regulatory compliant and hosted on a secure cloud infrastructure.
• Over 200,000 surveys have been sent through the platform.
• Operations span more than 30 countries.
• In-house subject matter experts are available to support clients.

Clinvigilant positions its eClinical suite as a cost-effective alternative for organizations seeking a highly configurable, all-in-one solution for managing clinical trials from data capture through trial master file management and patient engagement.