Our team has several decades of experience in startup, small and large corporations. We have started companies ourselves and helped others create successful organizations. Whether you need a business plan, looking for a strategic partner, perform due-diligence on a potential acquisition target, or consider change management, we can help accumulate pertinent data and provide insights that can help you make an informed decision.
SCIENTIFIC / CLINICAL SERVICES
All of Opus Three’s activities are based on a solid understanding of the science that drives an assignment. However, we don’t believe that understanding alone is sufficient – we want to be able to help our clients innovate and grow, find new ways to solve a problem. We can help you identify the right technologies and platforms, find novel or alternative ways to generate critical data, or design research studies, all with an eye on regulatory context and market access to ensure a focused product development.
The conundrum of a precision-based approach to medical product development is that it often starts with the opposite: the analysis of heterogeneous data. Such analysis can easily result in significant multivariate problems, which can only be alleviated using advanced analytical tools. If your data set is too complex to easily identify the markers that may be useful for selecting patients for a clinical trial, finding characteristics that may expose a patient to potential harm, or if you need a model to find potential new indications for a molecule, we can support your needs
REGLATORY / COMMERCIALIZATION
Our team of regulatory experts has first-hand experience working at the FDA as well as in the pharmaceutical and diagnostic industries developing products regulated by the FDA. We believe that successful product development is based on carefully planning ahead and identifying and choosing the right regulatory tools for productive interactions with regulatory authorities. We can help you addressing these needs for individual products as well as create comprehensive strategies for entire portfolios.