www.axon-cro.com

Axon CRO has extensive resources and expertise to design and conduct studies on a regional basis, and prepare and submit regulatory submissions in Central and Eastern Europe. A typical Trials Management Services project may involve the following components:

• Feasibility study
• Project management (incl. reviewing the proposal and budget)
• Hospital/investigator contract negotiation (lawyer consultancy)
• Study drugs packaging, blinding, labeling and distribution (GMP)
• Investigator site selection and qualification, GCP training (certification)
• Organize and active take part in investigator meetings (start up, close up)
• Investigational site management (pre-study, initiation, close out)
• Investigational site monitoring
• Medical monitoring and drug safety (SAE, ADR processing)
• Data management (incl. statistical analysis)
• Analysis and reporting
• Regulatory fillings (from submission to final report)
• Archiving of study materials

Trials Management Services may be performed exclusively by Axon CRO or in collaboration with the sponsor's internal staff or other CROs. Axon CRO has the ability to conduct single-site studies, multi-site domestic studies, and international studies in Central and Eastern Europe.