In medical device product development, the clinical study phase is the most time consuming, least predictable, most expensive, and most important. NAMSA’s clinical research management services utilize optimal strategies and tools to guide you through, from study design to final clinical report. Our engagements range from á la carte to full service, depending on your needs.
People and Procedures
The NAMSA advantage starts with our clinical study management experts, who average more than 20 years in the medical device industry and have experience running all manner of clinical studies, from first-in-man procedures through multi-center randomized global IDE trials.
Each NAMSA client study undergoes a periodic internal review where executives and project management peers scrutinize key factors such as quality, costs, timelines, and potential risks.
NAMSA’s clinical trial service organization is ISO 9001:2008 certified. As such, we have well-established SOPs for the planning, initiation, and conduct of studies. This includes template documents, checklists, and forms. We also are meticulous about planning and communication with both sponsors and investigative sites, and we adhere to GCP, ICH, and FDA standards for data integrity, patient protection, and regulation.