International project management
Our experienced international project managers and study managers ensure top-level management of observational studies and customer support in different therapeutic areas.
We have special experience in dealing with European, fragmented clinical research rules and national adaptations. This knowledge allows MediNeos clinical operations to efficiently cover all European countries, while our capabilities extend to US and Canada and possibly other countries based on demand. Our research operations are currently managed from the following networked sites: Modena (HQ), Paris, Prague, Madrid, London, Konstanz, Rockville.
MediNeos clinical operations are staffed to manage over 1.000 sites per year and about 300 new sites per year and are easily extended to all EU countries, supporting also USA and Canada.
Our internal team of experienced biostatisticians ensures proper study design and statistical analysis in all projects MediNeos is involved in. MediNeos biostatisticians are actively engaged in local and international statistical societies, keeping their professional competence and expertise constantly updated.
The MediNeos biostatistics unit has an extensive knowledge of SAS System, our software of choice for data management and statistical analysis in complete compliance to our GCP-inspired SOPs.
Data Management and technology systems
In order to efficiently and effectively manage data from international projects, we secured to our organization state-of-the-art technology. Extensive use of safe and reliable electronic systems enables us to digitalize and collect clinical data, also in the remote-monitoring settings. MediNeos employs different systems according to the specific characteristic of each project and the kind of data to be collected.
Our systems have been validated in compliance to FDA 21 CRF part 11, Annex 11 to EU GMP, and GCP, and according to GAMP5 and MediNeos Quality System
Our web-based, data-management system has restricted access to authorized personnel. It was developed with the purpose of Data Management, Data Entry and Data Validation during clinical and observational studies conducted in Remote Data Capture settings.
All MediNeos internal systems are installed on an highly reliable infrastructure based on state-of-the-art components (Flexpod: Cisco & Netapp).