UNITY vs. Greenlight Guru Clinical

Greenlight Guru Clinical

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What is UNITY?

The analysis of medical imagery powered by artificial intelligence is enhanced through advanced automation of clinical data workflows. Available as either a web-based SaaS or an on-premise solution, UNITY has gained international credibility from top medical technology companies and healthcare organizations for its proficiency in collecting thorough, reliable, and compliant data. Its integrated features for Patient-Reported Outcome Measures (PROM), electronic Case Report Forms (eCRF), and medical image analysis streamline critical data gathering activities, which in turn accelerates and reduces the costs of clinical trials. RAYLYTIC's Imaging Core Lab brings years of expertise to the automated and independent evaluation of musculoskeletal structures and device performance, particularly in the spine, hip, and knee, offering clients exceptional analytical and operational support. This state-of-the-art capability guarantees that healthcare professionals can depend on high-quality data for their decision-making, ultimately enhancing patient outcomes and fostering greater trust in medical processes. By implementing these innovative solutions, healthcare systems can greatly improve efficiency and accuracy in clinical trials.

What is Greenlight Guru Clinical?

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.