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Clinical Planning and Strategy

Looking to bring a new medical device to market? We can help.

Bringing a new medical device to market requires the successful planning and execution of clinical trials based on the regulatory strategy developed for the product – the use for which it’s being designed, its level of risk, and the target patient for which it is intended.

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Our clinical research team is highly experienced in developing and supporting clinical trials to help ensure their success. They work closely with our regulatory specialists to help create a clinical strategy that is most appropriate for your product and its intended use.

Our deep expertise and extensive experience can save you time and money by keeping your new device on track and on budget, from pre-market clinical trials through post-market studies. 

Our services include: 

Pre-Market

Feasibility Studies/First-In-Human. These studies provide important safety insights for products and procedures that are high risk and/or have never been tested in humans.  

Studies intended for Regulatory Submissions. Our team is experienced in designing successful studies demonstrating statistical significance of evidence to help determine reasonable assurance of product safety and effectiveness for 510(K) and PMAs. 

Post-Market

Post-Approval Studies. If the FDA requires post-approval study, we can design an effective study to clearly demonstrate the continued safety and effectiveness of your approved device.

Post-Market/Registries. Post-market surveillance can provide real-world insight into product safety and effectiveness. We offer clinical registry development designed to collect, analyze and interpret large amounts of product data, useful for monitoring on-going product performance and providing marketing support. 

Clinical trials are growing in complexity, compounded by increasing regulatory compliance issues, and high trial costs. We can help you effectively manage risk, control costs, accelerate your timeline, and increase your chances for successful outcomes by preparing a clinical trial plan and strategy custom-tailored to your product and resources.

I need help NOW!

Have you received an FDA 483 notice or a warning letter? Are you struggling to meet new EU MDR or EU IVDR regs? We can help you respond quickly and effectively to help prevent a difficult situation from getting worse.

Need FDA or EU MDR/IVDR audit assistance?

Don’t go it alone. Our deep, firsthand experience with FDA and EU MDR/IVDR audits can help you minimize risk and business disruption.

Are you a start-up?

We’ve helped a wide range of start-ups develop effective regulatory strategies to obtain FDA and EU MDR clearances. We’ll work with you to develop an appropriate domestic or global regulatory strategy to help ensure compliance and product approvals.