Clindata Cloud

RegDocs Connect gives your operational and regulatory teams the tools they need to prepare complete and compliant submission ready documents and records. Built with the end user in mind, collaboration, automation and quality are the foundation of this solution. Automated workflows manage your records lifecycle from draft to final, enabling your team to be in complete control of your regulatory documents at all times. Mapping of document types to the EDM reference model and eCTD facilitates organization and retrieval of documents for inclusion in regulatory submissions. Proprietary tools such as PDF/A Publishing, document classification, and unique document identifiers provide a powerful regulatory document management solution that pulls information from across your organization, into one manageable solution. With the rise of electronic submissions to regulatory agencies and the increased complexity of drug development, the ability to produce submission-ready, quality content

uMotif is a modern eCOA/ePRO and eConsent platform designed to power clinical and real-world research. Developed in collaboration with patients, the platform delivers unrivaled engagement, transforming the speed, quality, and accuracy of data. By combining uMotif's eCOA/ePRO with continuous glucose monitoring data capture, the platform delivered unprecedented data compliance rates for a pan-European diabetes study. In an immunology study, the patient-centered eCOA/ePRO solution helped the sponsor complete data capture requirements six months early. In an FDA-required CNS study, participants were engaged to capture submission-ready ePRO through their own devices. uMotif has always designed for patients first, with a relentless focus on understanding the patient journey and what drives patient behavior. This deep knowledge allows the design of software that best meets the needs of patients and delivers exceptionally high levels of engagement to study sponsors.