CLINr+
Medical Equipment - N/A, N/A, GB
CLINr+ Employees
Jacqueline Druten
Principal Consultant - IVDR, MDR, Health Economics and Clinical Affairs
CLINr+ Details
CLINr+ provides the Medical Device, In-Vitro Diagnostic, SaMD, and Biotech industries with specialised consulting services in Clinical Affairs, Regulatory Compliance, Medical research, and Product Management. We support clients to find, generate and transform their product data into strategic insights, regulatory compliant reports, and SMART plans through our expert and Ai driven CLINr+ personalised solutions approach. Our subject matter services include: - systematic literature searches, Medical writing, Market access strategy, Clinical Development Planning, Clinical Evaluations (CEP/CER and PEP/PER), Post-market surveillance (PSUR, PMSR and PMCF), Clinical and Technical Documentation, Clinical Investigation planning (PMCF planning, REC approvals, CIP, IB, CIR, DMP, EDC eCRF, SAP and SAR), Project Management and connections with Subject Matter Experts.CLINr+ Intelligent Automation brings leading disruptive Ai automation infrastructure to manufacturers to automate clinical evaluation and product surveillance workflows to delivers real-time post-market feedback and powerful insights with speed and agility. This enables our customers the agility to accelerate clinical development, expedite regulatory compliance and assure ongoing commercialization of innovative medical treatments that improve healthcare outcomes for patients.We serve the Medical Device and Life-Sciences Industry and promote patient care and quality of life by supporting manufacturers to place patient outcomes and safety in the center of innovation. Providing evidence-based clinical insight and automation solutions that support compliance and executive decisions to make informed investments, clinically proven innovation and provide evidence-based medical communications
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