We refine a well detailed Target Product Profile, with a clear understanding both of the medical needs the new product aims at addressing, and the desired labeling. We define the data required to support regulatory approval of the product and foster its adoption by the medical community.
In collaboration with key opinion leaders and expert advisers, we optimize the required study protocols for relevance, scientific strength, time to result and cost.
We offer input to preclinical packages to determine and validate potential surrogate markers and mode of action, outline clear objectives, and provide judicious thinking to help make critical development decisions quickly and with a high degree of confidence.
During the execution of the Clinical Development Plan, our most important role either as add-on to an existing team or using our internal resources is serving as independent medical and technical leader and a single point of contact for all parties involved: sites, CRO, sponsor, IRB, committees, core labs, experts, and regulators.