La Crocina provides consultancy- and advisory services regarding Clinical and Regulatory Development, with an emphasis on Phase I-IIb studies.
Services include setting up development plans, selection, qualification and management of service providers, clinical study protocol design, translational approaches, PK/PD modelling, construction of budgets, risk management and decision trees.
Regulatory services include compilation of CTA/IMPDs, INDs, IBs, Scientific Advice/Protocol Assistance dossiers, Orphan Designation dossiers and support in responding to regulatory questions and requests.
Additional services include support to the Due Diligence process as well as compilation of Business Plans.
