Clinical Strategy for Medical Devices
A good clinical strategy gives you a competitive advantage, by bringing your device to market faster and supporting unique claims with solid clinical evidence. The clinical evaluation is a critical element in the CE marking pathway for a new medical device on the market. As a regulatory and clinical consultant, our clinical strategy support can help to ensure that your medical device proposed clinical plan will be sufficient to meet the requirements.
Designing a trial to meet the minimum FDA requirements is not sufficient to ensure product success. NovoZen Healthcare combines an understanding of regulatory requirements and processes with a critical market perspective to formulate a practical, robust clinical strategy that will change the treatment paradigm and drive adoption.
Running clinical trials is an orchestrated process — trust NovoZen Healthcare to conduct every trial with operational excellence. NovoZen Healthcare partners with biopharmaceutical and biotech companies, investigators, site staff, lab and technology vendors, and regulatory authorities to reinforce patient safety and access throughout every phase of research. All play a part in delivering the quality data that can drive promising compounds forward.
Whatever the size or scope of your study, Parexel provides the comprehensive clinical development services you need, from First-in-Human through Phase IV and post-marketing follow-through. We also have the regulatory consulting expertise, clinical trial operations management, payer and market access planning, medical communications and education capabilities to see your journey through efficiently and effectively.
Bring Your Device Faster To The Market
We will always take into account the feasibility of operational plans on a budget, timelines, and marketing requirements. A good clinical strategy gives you a competitive advantage, by bringing your device faster to the market and supporting unique claims with clinical evidence.
Sufficient Clinical Evidence
You are in the development of your medical device and need evidence to support the clinical performance and safety of your device. compliance to (product) standards, verification testing, literature and clinical studies can contribute. In a clinical strategy, we will consider together with you how to gather the necessary evidence.
Product Development Phases
Your Clinical Strategy develops together with your device during the distinct phases of product development as design decisions might influence both risk management and claims. NovoZen Healthcare provided clinical strategies for all kinds of devices from all classes, at start-ups companies and multinationals. Regardless of the position of your company and device, we are able to help you with your strategy.
Expertise
NovoZen Healthcare's experts are very familiar with medical device development processes and are able to identify the correct regulatory requirements to be addressed and develop the appropriate research question(s). A good clinical strategy gives you a competitive advantage, by bringing your device to market faster and supporting unique claims with solid clinical evidence.
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