The need for clinical evidence to support regulatory submissions and/or gain insurance reimbursement can be a significant cost to a small to medium size company. In the United States, the FDA may request this evidence as part of a 510(k) submission and requires it in a Premarket Approval application (PMA). In the EU, the need for clinical evidence may arise during the CE marking process as a result of a lack of clinical evidence of safety and performance. Based upon how the need arises, clinical study designs can vary widely, and one must be certain not to lose sight of the ultimate purpose of the clinical study.
Clearly, if you have a brand-new medical product treating a condition that has yet to have a successful treatment, a classic phased approach to clinical studies is necessary during product development. However, if you have a new technology embedded in your medical device/combination product and simply need to demonstrate that the new technology continues to deliver the same or an improved therapeutic effect you should not try to "force fit" this type of study design to meet a typical phase III pharmaceutical model. You need to be able to "think outside the box" to develop a protocol design and an investigational plan that complies with Good Clinical Practices, FDA guidances, and ISO 14155, while focusing on the objective at hand. RQMIS has worked together with clinicians and clients to design and manage studies that range from small 50 patient studies to demonstrate that a medical device modification has had no significant impact on safety and performance, to large multisite clinical studies spanning multiple countries to demonstrate that a medical device with a new intended use safely and effectively achieves its intended outcome.
RQMIS can provide the necessary resources and help you design and manage a trial or study that suits your business needs. We can support all of the activities required to design, gain regulatory approval, and manage a clinical trial. We can also assist with individual tasks related to clinical studies including:
Biometrics Project Management
Startup activities (including regulatory submissions)
Site selection and management
Onsite technical support
DSMB/CEC Management and Functional sourcing
Bioresearch Monitoring services include an independent audit of your clinical study to assure compliance with Good Clinical Practices, regulatory requirements and confirmation of patient protection and data integrity. RQMIS can assist with the following:
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