ShareCRF vs. Greenlight Guru Clinical

Greenlight Guru Clinical

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Ratings and Reviews 7 Ratings

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Ratings and Reviews 12 Ratings

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What is ShareCRF?

Within just a few hours, you can design an electronic Case Report Form (eCRF) that is as user-friendly and straightforward as its paper counterpart. This approach will significantly reduce the typical challenges encountered in data collection for both pre-authorisation and post-authorisation studies. When you set out to create an eCRF, it’s crucial to utilize an Electronic Data Capture (EDC) system that offers flexibility, enabling you to customize it for various study types. Additionally, the EDC comes equipped with several monitoring and management tools that can greatly streamline the study oversight process, saving you both time and energy. It is essential to employ a reliable system that instills confidence in the sponsor and facilitates the gathering of high-quality data. Addressing any data errors only during the analysis phase can lead to complications, as it may require you to track down investigators for corrections after the fact. Therefore, strive to keep the eCRF creation process efficient and straightforward, ensuring that it meets all necessary requirements without unnecessary complexity. By focusing on these elements, you can enhance the overall effectiveness and accuracy of your research.

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.