Clinical Trial Services
Our consultants have expertise in clinical trial methodology and have designed all phases of clinical trials from early feasibility to pivotal phase III studies to support PMA/HDE device applications. We work with your team to design a rational clinical program that gets the data for your next key milestone, whether it’s a seed funding round or PMA approval.
The biostatisticians we work with have extensive medical device experience with PMA/HDE devices for novel diagnostic and therapeutic methods.
Our services including protocol development, CRF development, statistical planning and analysis, and regulatory agency engagement (ITA/IDE). We can assist your team in managing a trial internally, including site selection, or in helping to hand off larger clinical trials to an international CRO.
Clinical evaluations are a key component of obtaining European market CE marking for all classes of medical devices. We have extensive experience developing turnkey clinical evaluations in accordance with MEDDEV 2.7. 1 (Rev 4) for a variety of diagnostic and therapeutic products.
Canada is an excellent location to conduct clinical studies, ranging from first-in-man to multi-center pivotal trials. We can take your project through pre-submission engagement, to Investigational Testing Authorization (ITA) preparation, to licence applications (Class II-IV).
Quality ManagementISO 13485, MDSAP, FDA QSR
We have experience setting up and optimizing medical device quality systems for companies ranging in size from 4 to >1,000 employees. Our approach involves carefully designing the quality system for compliance without compromising the entrepreneurial flexibility that brings great products to market. We can author your quality system, manage the certification process with your registrar, and provide resources to act as quality management while training your internal resources.
Our quality management professionals are certified biomedical auditors and can audit ISO 13485, FDA, and MDSAP quality management systems.