Our clinical strategy services include support for all FDA regulated product types, including Rx and OTC drugs, medical devices, foods, cosmetics, and dietary supplement products.
We excel at working with your internal development team and /or your CRO to evaluate the available clinical data related to your product and determine whether it will provide you with the product label you are looking to develop, including the claims you want to make for your product.
Our team will assist you in identifying new or proposed regulatory guidelines or rulings that can impact expectations for future trials. As part of our process, we integrate knowledge corresponding to the key users and/or payers and understand how they will evaluate the new product based on the data generated. Our assessment includes measures of safety, efficacy, and ease of use that will be required to influence your audience.