Conceptual consulting for clinical trials

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  Site Initiation: selection of research site and Investigators, convene Meetings with investigators, personnel training, site Initiation and set up

• Providing scientific advice for getting FDO approval (pre-IND meeting)
• Planning and management of translational research projects (bench-to-bedside) involving leading academic experts (pre-clinical, clinical, manufacturing)
• Budget planning & Contract management
• Task scheduling and task assignment (in accordance with GCP)
• Support for identifying contract manufacturers (IND, placebo), supervising contract negotiations and project management (based on FDO regulations)
• Identification and verification of the suitability of potential study sites (pre-study visit, feasibility checks) – in close cooperation with the clinical management of the study project