Greenlight Guru Clinical vs. CORE (Clinical On-demand Research)

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.

CORE (Clinical On-demand Research) offers an extensive range of specialized services that include the design, development, and management of electronic forms used in clinical trials across the UK and globally. Beyond creating the essential forms, CORE also manages randomization processes, data oversight, and provides vital study statistics, ensuring that researchers have the key information they need. This organization plays a critical role in gathering significant data for both academic and commercial research sectors. Notably, CORE has formed a successful partnership with FormsVision, which originated from an FP7 EU funding initiative, and has integrated the ALEA eCRF (electronic Case Report Form) to improve trial execution in the UK and New Zealand. The dedicated team at CORE is prepared to deliver a wide range of services, which encompass database development for CRFs, management of randomizations, coordination of drug supplies, and ePRO (ALEA) solutions. They also provide data hosting services for various file types and offer expert assistance with funding applications, statistical analysis, and protocol development. By delivering this comprehensive array of services, CORE solidifies its role as an essential collaborator in the progression of clinical research initiatives. Their commitment to enhancing research methodology and data integrity further underscores the importance of their contributions to the field.