Our team has extensive experience spread across all trial categories from early-stage feasibility studies through later stage pilot & pivotal studies, to PMS studies, in various therapeutic areas.
We cover the span of the clinical research process and can provide you with full project management or modulated services, such as study design, site qualification, submissions, CRF design, monitoring, study plans (CIP), reports, clinical audits, etc., as applicable, according to the applicable regulatory requirements (such as ISO 14155, MDR and FDA CFRs).
The conduct of clinical investigation audits of Sponsors, clinical investigators, and investigation sites is essential to determine compliance with applicable agreements, sponsor procedures, EC requirements, the clinical investigation plan, Good Clinical Practice (GCP), IS0-14155 and where appropriate, national regulations. These audits may cover all involved parties, systems, processes, and facilities, and are independent of, and separate from quality control functions or routine monitoring.
Our clinical experts have the relevant required experience to perform clinical audits, as needed for your organization, to ensure and provide evidence that your clinical investigations are conducted in a manner that produces scientifically and medically valid data.
A good Usability Engineering process, also called Human Factors Engineering (HFE), is helping you to ensure the safety of the use of your medical device for the patient, user, and others. During this process, we can identify and mitigate risks related to the interaction between the user and the device during its intended and foreseeable use.
This process consists of several phases, that are all integrated into the development of the design of your device. We have the expertise and the field experience to accompany you from the development phase, to identify the relevant specifications, analyze the risks, and create, organize, perform, and report custom-made formative and summative studies to demonstrate your user can safely use your device.