Our People Make the Difference
Our experts bring extensive therapeutic knowledge and insight into assisting life
science firms in developing and executing their regulatory strategies, clinical
development, and post-approval research to ensure a successful drug and medical
device development program.
We assemble the best team for each client engagement and believe that our dCRO culture
yields substantial benefit for our clients. For example, we have very low employee
turnover, which promotes stability and consistency. In addition, 70% of our clinical staff
has over eight years of industry experience and 90% of our regulatory, scientific, and
medical team has over 15 years experience.
The Right Experience
Drug Development
Our experts bring extensive therapeutic experience in building a welldefined strategy and clinical plan to maximize the success of your drug
candidate throughout its development lifecycle.
Medical Device Development
Our device experts will help you navigate the increasingly complex
global regulatory and clinical landscape in support of your PMA, 510(k),
and CE mark application.
Clinical Development
From managing your entire clinical program to conducting an individual
clinical trial, our clinical teams can help you affordably design and
operationalize your protocol and provide visibility into your studies.
Regulatory & Strategic Development
Whatever the scale or complexity, we have the breadth and depth of expertise
to move your products from the lab to market while maximizing your success
with regulatory authorities, worldwide.
Post Approval Programs & Registries
Once a product is approved for use, understanding its efficacy and safety
profile can be challenging. Our post-approval specialists deliver integrated
phase IV research and registry services designed for your epidemiology,
health economic, and safety programs.
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