Hinge Clinica Revenue and Competitors

Hinge Clinica is a global Clinical Research partner that provides clinical research services with Global appeal. We render End to End Clinical trial services, Pharmacovigilance, Medical device MDR compliance and Regulatory services to life sciences industry under strict adherence to ICH-GCP, US FDA, EMA and comply with national and international regulations; dedicated to a high level of protocol compliance and proactive communication. Our functional teams have rich global experience in handling of end to end complex global trials. Our clinical operations team, project management and quality teams constantly strive to ensure the study requirements, regulatory compliance and study timelines. Medical & Scientific writing services Clinical Trial Management Clinical Data Management Safety reporting & Pharmacovigilance Biostatistics & Statistical Programming Regulatory Consulting Quality & Audits Project Management Food & Nutraceutical Trials Medical Device Services: Clinical Evaluation & Investigation Plans (Protocol Writing) CER (Clinical Evaluation Reports) Writing Review existing Clinical Evaluation Reports against the MDD and MEDDEV 2.7.1 rev 4 and support for documentation Feasibility Studies/Pilot studies Pivotal Studies PASS (Post Authorization Safety Studies) PMCF (Post Marketing Clinical Follow up Studies) Post Marketing/Observations Studies eIFU Product Labeling Literature search/reviews Publications EU MDR/IVDR Support: Overall EU MDR/IVDR compliance strategy Change in Notified Bodies Labeling review and updates Tech file remediation Design dossiers and renewals CER writing and review Post market surveillance plan development EUDAMED database management EU UDI implementation Regulatory Strategy Development: Gap analysis of existing documentation Regulatory strategy & Project deliverables US/EU/CA/ROW Marketing strategy support Due diligence