Greenlight Guru Clinical vs. Entrypoint i4

Medical device and diagnostics companies running clinical studies are often stuck configuring EDC software that was built for pharmaceutical trials and never designed around FDA, EU MDR, IVDR, or ISO 14155 requirements. Greenlight Guru Clinical solves that by being the only electronic data capture (EDC) system built from the ground up for medtech, so teams aren't reworking someone else's pharma template to fit a device study. Designed exclusively for medtech, Greenlight Guru Clinical combines an easy to use clinical data platform with industry leading customer service, so teams generate reliable, compliant clinical data with confidence. Get a single, validated platform covering the full lifecycle of a device or diagnostics study, including: Electronic Data Collection and eCRF design, with GCP compliant structures and built in audit trails ePRO/eCOA for patient and clinician reported outcomes, collected in person or remotely on any device eConsent for compliant, auditable enrollment Randomization (RTSM) for controlled and comparative studies PMCF Surveys for post market clinical follow up under EU MDR Adverse Events Reporting built into the platform Leading-edge, open API for connecting study data to other clinical or quality systems Greenlight Guru Clinical supports pre-market clinical investigations, post-market surveillance studies, registries, and human factors testing, and is used by both device and diagnostics manufacturers and by contract research organizations (CROs) that specialize in medtech. A validation package is included with every product update, removing the ongoing burden of software revalidation from the quality team. Every customer also gets a dedicated customer success manager with real medtech experience, not a generalist software account rep. For manufacturers already on Greenlight Guru's quality management system (QMS), Clinical extends into one connected platform spanning quality, product development, and clinical evidence.

Entrypoint is a comprehensive platform designed for the development, deployment, and management of customized data entry applications, allowing users to access data entry and system administration capabilities from virtually anywhere. This collection of user-friendly tools enables individuals to create, execute, and manage a wide variety of bespoke data entry applications, featuring built-in validation, editing functionalities, and various export options. With a plethora of integrated features, Entrypoint facilitates the incorporation of sophisticated elements such as range checks and table lookups, enhancing the overall user experience. The conventional practice of collecting information through paper forms followed by manually inputting it into a digital system is not only labor-intensive but also susceptible to errors in transcription. By adopting electronic forms for direct data entry into a database, organizations can effectively eliminate the cumbersome intermediary paper process and its associated pitfalls. Additionally, the shift to electronic data capture proves increasingly beneficial for organizations confronting higher data volumes and rising costs, as it promotes streamlined processes and improved efficiency in data management. Therefore, Entrypoint emerges as a vital resource for organizations aiming to upgrade and modernize their data processing methodologies, positioning them for greater success in a digital landscape.