OnlineCRF vs. Greenlight Guru Clinical

Conducting clinical research is often a lengthy and challenging endeavor, which can create significant stress for the project team and complicate overall management. To alleviate these burdens, we have developed a solution aimed at streamlining electronic data capture within clinical trials. Our dedicated data management team offers comprehensive support for gathering clinical data, enabling you to focus on the most critical aspects of your research. Additionally, we can incorporate custom features or specific requirements tailored to your project's needs. The Electronic Data Capture (EDC) system is also budget-friendly, making it an ideal choice for researchers with limited funding. Our team has meticulously configured the EDC tool to align with your project specifications, so you can avoid the hassle of system validation and setup. Furthermore, the source code and database of the EDC system are securely housed in a European Data Center or any location you prefer. With a multilevel backup system in place, you can trust that your clinical data remains protected and secure throughout the research process. This level of flexibility and support empowers researchers to concentrate on their core objectives and promotes more efficient trial execution.

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.