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Creating a lean approach to clinical research
The clinical studies can be the most time consuming, least predictable, most expensive, and most important part of your development effort. We work smart from the start, saving time and preventing costly rework by optimizing strategies and tools to guide our clients through. Our clinical experience encompasses a broad range of technologies, therapies, and indications. With a tight focus on devices, combination products and IVDs. Our expertise include designed and conducted trials—from first-in-man through postmarket registries—whether the intent is to obtain market approval, improve reimbursement, or generate publications.
We know that the best clinical data requires knowledgeable team and product-specific expertise. So we build team of professionals with the right backgrounds and provide them with the best systems and tools available. All aspects of clinical research including study protocol development, clinical project management, study budgets, Site management, monitoring, auditing, clinical safety, biostatistics, data management and database development (EDC and CTMS) are available as part of our service.
Our experience spans the globe: North America, Europe, Asia, South America, and Australia. Our systems and staff have been meeting needs and creating success for both start-up enterprises and large companies with proven success.