QbD Clinical, proud member of the QbD group, is your expert clinical solutions provider specialized in medical devices and biotech. We offer a unique combination of global CRO services and consultancy. It is our mission to be a passionate, dedicated business partner with a focus on excellence to provide tailored solutions. Our clinical research expertise covers the full spectrum of clinical trial activities, ranging from initial concept development, regulatory strategy, protocol development, medical writing, vendor management, risk-based strategies, feasibility, site/investigator selection, site start‐up including ethics committee and competent authority submissions, site management including on‐site or remote (risk-based) monitoring, data management, biostatistics, e-solutions, EDC, IXRS, lab and core lab services, safety, medical monitoring and CEC/DSMB services, all on a global level. In addition, we provide consultancy solutions for the medical device, biotech and pharma field covering any role, function or therapeutic area, remote or office-based support, individuals or teams on an FTE or project basis for short or long durations. Lastly, we also offer quality assurance (QA) and quality control (QC) services (GDPR services, audits, audit/inspection readiness, risk-based approaches, QMS setup and maintenance, root cause analysis and CAPA, SOP writing and review, ...) as well as performance and competency-based professional training. QbD Clinical is a proud member of the QbD Group. QbD offers life science companies specialized expertise and software in the field of quality management, regulatory, validation and tech transfer. www.QbDgroup.com