is an expert clinical solutions provider that offers a unique combination of global CRO services, staffing solutions (flexible resourcing and search & selection), quality services including GDPR and risk-based approaches as well as training.
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 central (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 global flexible staffing solutions and tailored search & selection 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.
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, …)
Lastly, we specialize in performance and competency-based clinical research training. Next to clinical research regulations, standards and guidelines, we offer training on specific clinical research skills as well as applicable soft- and line-management skills.
It is our mission to be a passionate, dedicated business partner with a focus on excellence to provide start‐to‐finish clinical trial activities tailored to the timing, budget and specific needs of our clients.
Want to know more? https://qbdgroup.com/en/services/clinical-solutions/