Study start-up
Since 2010 Ramus Medical has successfully completed more than 32 BA/BE studies. Our Study Start-up Department collects documents and submits them to the competent authorities and Ethics Committees quickly and competently. The team members communicate with Investigators, Ethics Committees and Administrations to resolve critical issues. They handle requests for clarification and amendments as well as contacts with site administrations to finalise financial agreements. Ramus Medical has a study site which meets all regulatory requirements for the conduct of BA/BE studies. It is at our disposal all the time.
Feasibility assessment
Site Qualification & Selection
Investigational team selection
Ramus team for BA/BE studies
Mediation of contracts or signing the contracts on behalf of the Sponsor and other parties
Regulatory submissions
Organization and conduct of investigator meetings