;)
Viscera´s Challenge
US East-coast biopharma startup, a spinout from Major Pharma, repurposing an asset to for a women’s health indication, in need of clinical development expertise as well as support with regulatory strategy and investor interactions.
The team at Adnovate provided dependable and strong scientific support whilst adopting a flexible working and financial model as funding was being secured. The high-quality deliverables they produced helped with execution of forward strategy as well as providing the basis of some of the materials used to support fund raising.
Gareth Hicks | CEO Viscera.
Adnovate Clinical’s Solution
Full clinical development team provision, ranging from medical leadership and support, to strong statistical input and clinical operations expertise. Target Product Profiles (TPPs) were developed dynamically and interactively with the client to optimize the chances of success through development, a variety of clinical development plans (CDPs) were explored and a path to NDA plotted. After synopsis development and KOL interactions, feasibility exercises and bids were carried out with CROs in preparation for Phase I and II studies and to help with investor fundraising. Medical and scientific support was provided for FDA PIND interactions.
