From First in Man and Proof of Concept to Phase IV post-marketing studies, and everything in between, INNOPHARMA provides a broad range of global facilities and therapeutic expertise to meet your clinical trial needs. Within our organisation we have the experience and local presence to help you succeed regardles of the sides or scope of your project.
Let us manage the complete clinical trial process, including planning, patient and investigator recruitment, data management, biostatistics, clinical pharmacology, regulatory compliance, and much more.
INNOPHARMA is currently conducting many local and international clinical trials in Italy, Western and Eastern Europe and the U.S. We interact with a network of clinical research sites and resources with experienced Investigators in a broad range of therapeutic categories.
Clinical Project Management
- All aspects of trial design, conduct and reporting are handled in agreement with the Sponsor
- Trials are managed according to ICH-GCP guidelines
- Project Management is based on an electronic planning and management tool
- Recruitment rates and detailed progress reports are frequently provided to the Sponsor
- One Clinical Project Manager (CPM) is responsible for all aspects of the trial and is the primary contact person for the Sponsor
- The Clinical Project Manager is supported by Clinical Research Associates (CRAs) and Clinical Trial Administrators (CTAs)
Clinical Trial Monitoring
- CRAs have a University degree in Science, Pharmacy or Medicine. They are accurately trained in GCP/ICH, Company and Sponsor SOPs
- Clinical Trial Monitoring activities consist of: Trial set-up, monitoring and close out activities
- Investigator Meeting participation
- Source Document Verification
- Adverse Event management