Clinical Research IO

Clinical Research IO provides a comprehensive platform designed for clinical research sites, networks, academic research, and sponsors. The company offers a variety of products including eSource, eConsent, Publisher, Medical Record API, Reviewer EDC, Patient Stipends, Site CTMS, Reporting, and eRegulatory. These tools support both investigator-initiated and industry-sponsored research, helping sponsors obtain better and faster data at significant savings. The Medical Record API delivers electronic medical records and clinical care insights to investigators within minutes, while the site-based CTMS manages patient recruiting, scheduling, financial management, and more. The reporting module allows users to filter, sort, search, download, schedule, and export data efficiently. Sites can issue and load patient stipend cards with preset or manual amounts, and the centralized Publisher application enables the creation, versioning, and distribution of study templates to sites. Reviewer EDC allows sponsors and CROs to review eSource data in real-time, query, lock, medical code, and extract the data. The eConsent tool automates the completion and execution of the Informed Consent, integrating seamlessly into the eSource workflow, and eRegulatory streamlines regulatory workflows with paperless binders and an electronic delegation log. Clinical Research IO also provides a direct data access program for enterprise clients to query their data directly. The company’s infrastructure is hosted within secure private networks via public cloud providers, ensuring compliance with regulations such as 21 CFR Part 11, Annex 11, HIPAA, and GDPR. Servers are located in the United States, Canada, Germany, and Australia to comply with international data protection laws. The platform supports Single Sign-On (SSO) integration to enhance security and streamline user authentication. Recognized for reducing protocol deviations by 40% and lowering FDA audit risk by 70%, Clinical Research IO supports remote collaboration and monitoring for clinical research sites. Additionally, the company provides tools and resources like SOP templates and validation exercises to help clients achieve full compliance, and offers a Study Design Marketplace with pre-approved eSource study design templates.