In order to manage your clinical trial from beginning to end we cover the following services amongst others:
Design and Development of Study Documents
In compliance with your requirements we design case report forms, worksheets and study filing systems (TMF, ISF and IOF). With pleasure we advice you.
Communication with Ethics Committees and Competent Authorities
We master for you the barrier of applications e.g. to German ethics committees and regulating authorities such as BfArM (The Federal Institute for Drugs and Medical Devices) and BfS (The Federal Office for Radiation Protection) and handle relevant correspondence and reporting (e.g. annual and SAE reports).
We handle the entire site management for you: from site initiation visit and site correspondence to close-out visit.
To ensure valid clinical data and trial conduction according harmonized standards and applying regulations we visit participating sites for you.
We create significant documents (e.g. interim or final reports) describing the research results.