ClinVigilant eClinical

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ClinVigilant eClinical is a comprehensive, cloud-based platform designed to streamline the management of clinical trials across all phases . By integrating various modules such as Electronic Data Capture , Electronic Trial Master File , and patient engagement tools, it offers a unified solution that enhances efficiency, ensures regulatory compliance, and improves data quality. The platform's user-friendly interface and customizable features allow for rapid study setup without the need for programming expertise, making it accessible to a wide range of users. Key Features and Functionality: - Electronic Data Capture : Facilitates the creation of electronic Case Report Forms from paper CRFs, streamlining data collection and management. - Electronic Trial Master File : Automates the creation, management, and tracking of trial documentation, connecting sponsors, CROs, and sites for real-time monitoring. - Patient Engagement Tools: Includes eConsent, ePRO, and eCOA modules to enhance patient recruitment, screening, consent processes, and data collection, supporting decentralized and hybrid research projects. - Rapid Study Deployment: Offers a highly configurable platform that enables study setup in less than four weeks, reducing time and resources required for trial initiation. - Regulatory Compliance: Ensures adherence to standards such as FDA 21 CFR Part 11, GDPR, and HIPAA, providing a secure and compliant environment for clinical data management. Primary Value and Problem Solving: ClinVigilant eClinical addresses the complexities of clinical trial management by offering an integrated, user-friendly platform that reduces setup time, enhances data accuracy, and ensures regulatory compliance. Its cost-effective and customizable solutions cater to the specific needs of pharmaceutical, biotech, and academic organizations, facilitating efficient and successful clinical trials.