- Expertise and management of all types of trials from Phase I
to IV with medicinal products/medical devices,
as well as
of diagnostic, procedure and chart review studies
- Experience in both sponsored and academic studies
- Experience in a wide range of therapeutic areas
- Consolidated network of academic investigational sites in 29
countries world-wide
What we can offer in the development and the conduction
of such trials?
Through our organisation and networking we can offer a full
range of services for clinical trial:
- Feasibility study
- Protocol and CRF/eCRF development
- Procedures and guidelines
preparation
- Centres selection
- Regulatory and EC submissions
- Investigators meetings
- Monitoring activities
- Centres management
- Data checks and cleaning
- Safety data management
- Medical Affairs and Safety
Surveillance
- Medical Review
- Quality control
- Statistical support to study design
- Statistical analysis
- Financial and administrative services
- Overall study management
- Essential documents management
- Medical writing
- Study reporting
- Publications
- Project management
- Monitoring
- Regulatory Affairs Management
- Medical Reviewing/Farmacovigilance
- Quality Assurance Management
- Financial Accounting
- Audit
- Training
- Centralised reading
(Echo, Holter Coronographies)
- Core Laboratory for centralised
- Bio-analytical assays
