It does not work without YOUR input
Before a new medicinal product is introduced to the market, safety, efficacy and tolerability have to be tested. YOU have the experience with your product and we have the experience how to bring YOUR product to YOUR planned market.
LaNova Consulting is involved in several phase II-IV, post marketing, registries and observational studies with large number of patients since many years. We have developed experts within the company in ethics and regulatory submissions for all European countries and some other countries worldwide, particularly for compounds and devices on the market. LaNova Consulting ethics and regulatory expert team will work with the local ethics committees and regulatory offices to provide the investigators with ethics and regulatory approvals in their countries according to the local rules and regulations within a short period of time.
As a part of our standard operating procedures,
LaNova Consulting provides important details for each step of the clinical study to the Project Managers. This process is initiated in the pre-engagement phase. The project manager
is assigned very early in the process in order to ascertain every facet of the study requirements as well as the unique needs of our client. A scoping session is conducted with the client in order to
determine the study’s order, magnitude, budget, communication procedure, deployment and numerous other requirements. The Project Manager leads the team dedicated to support the protocol and
study conduct from inception through completion and the PM will be the single point of contact for the sponsor during the study conduct. The team members are Lead CRA, IT Manager, IT Advisor,
Data Manager, Senior CRA, CRAs, Statistician, Project Assistants, Quality Manager and Equipment Manager.
The team within LaNova Consulting has supported studies mainly in European Countries, Central Africa, Middle East and some other countries in the following indication: