ServicesClinical trials are an indispensable part of the development and approval of pharmaceutical drugs. In principle, clinical trials are unbiased and with open outcome. They are intended to demonstrate the efficacy of new drugs and determine their compatibility.
- Study planning / counseling during study planning
- Planning of trial protocols / consulting during the creation of trial protocol
- Feasibility studies and evaluations
- Statistical consulting
- Review and clarification of regulatory requirements
- Obtainment of approvals from the competent federal authority (BfArM or PEI)
- Requests for approval by the Ethics Committee
- Clearing of the necessary procedures with the relevant Ethics Committees
- Study according to our "Standard Operation Procedure" (SOP) or that of the sponsor
- Maintenance and preparation of study records
- Support for safety follow-up
These services and others can be ensured by Beldio® Research and co-operation partners. The details of the studies can be discussed in a personal interview.