Vergio

Vergio offers holistic solutions to increase your drug development efficiency in the European Union. Our services are provided by multidisciplinary experts with an extensive experience in the pharmaceutical industry. They include: • Strategic advisory: Vergio offers strategic advisory services regarding drug development, drug candidates registration and market access in European Union. • Clinical development: We provide services to help life science and biopharmaceutical clients to design the clinical development of their drug candidates taking into account clinical and non-clinical data, regulatory and market access requirements, and operational/financial constraints. We offer medical writing and scientific articles preparation for the publication of your clinical study results. • Statistical analyses: We conduct review/audit of statistical analyses. To improve efficiency of the clinical trial design, we perform statistical simulations to explore the effect of key trials parameters and multiple scenarios. We further analyse clinical trials results to better characterize drug efficacy and safety. • Registration: We help life science and biopharmaceutical clients to define the registration strategy, to prepare the pre-submission steps (scientific advice, orphan drug designation procedure, pre-submission meetings, registration dossier preparation), and to support the registration process for centralized, decentralized and national procedures. • Market access We conduct research work on drug efficacy/safety to support efficacy, safety and benefit-risk such as (network) meta-analysis, systematic literature review. • Financials and due diligence: We offer business plan preparation services and we conduct audits of clinical data or development program for due-diligence purposes.