A Uniquely Collaborative Approach
Our clinical-development department designs, analyzes, manages, and monitors clinical studies of all sizes and scopes.
But one size does not fit all. Our experienced clinical-development department customizes each clinical program so that it is strategically and statistically designed to achieve valuable endpoints. Here, each clinical program is tailored to fit a project’s needs, from simple to complex, including evaluations to accomplish novel claims, prove enhanced formulations, and distinguish our products.
What’s more, our clinical-development department collaborates with our formulators from start to finish throughout the development process to design products capable of meeting the clinical-performance goals. The clinical-development team also works closely with regulatory affairs ensuring appropriate protocols are designed and executed to support regulatory filings with the FDA.
This uniquely collaborative partnership between clinical scientists and formulators not only facilitates greater speed and assurance of our in vivo performance, it also gives our formulators the opportunity to learn and contribute to the clinical-design process.
Together, these groups lead an uncommonly dynamic range of clinical studies, including:
- Phase I which includes bioequivalence, bioavailability, and a range of pilot studies to validate value propositions
- Phase II and Phase III studies from dose finding through efficacy, (e.g., improved patient compliance and experience studies)
- Post-marketing studies as a post-approval requirement by the FDA