Since 1994 an experienced team of dedicated research physicians and scientists is exclusively focusing on the conduct of clinical trials in our own ward. Primarily performing pharmacokinetic studies with renally or hepatically impaired participants, we are also involved in PK/PD studies in various therapeutic areas. Our strength lies in the combination of our long-term expertise and the established access to patients. We offer our sponsors continuous project support in assessment, planning and rapid study implementation, along with short communication channels and fast contract processing.
Our work is characterized both by a professional and personal atmosphere and by a cooperative partnership with the sponsors as well as with the study participants. We value the voluntary participation in the studies and take responsibility for the safety and well-being of our study participants. At the same time, we ensure efficient and reliable study conduct.
Our employees are specialized in clinical research and participate regularly in advanced training and continuing education. All steps starting with the planning of the study up to the completion of the study are subject to continuous quality controls.
A long-standing cooperation with laboratories, specialized outpatient clinics and dialysis centres is established. Daily clinical practice and continuous monitoring of the relevant GCP requirements are the reliable basis of this joint work.
What APEX offers for study planning:
• Collaboration/counseling on protocol design
• Review of the practical feasibilty of your study design
• Preparation and revision of participant information and consent forms
• Preparation of forms for source data
• Contact with public authorities
• Submission to the ethics committee
• Conformity check of the study against the German legal requirements
What APEX offers during study implementation:
• GCP-based conduct of phase I and IIa studies.
• Single and multicenter studies
• Recruitment of participants
• Care of specific patient groups, e.g. dialysis patients
• Patient accommodation and care
• Patient monitoring system (home emergency call)
• Clinical laboratory/safety laboratory
• Cardiac monitoring via telemetry system
• Study logistics (e.g. IATA-compliant shipping)
• Storage of study medication under controlled conditions
• Controlled sample collection, preparation, storage and shipment
• Data management: data entry and control
• Cooperation with specialized practices (e.g. nephrologists, cardiologists, neurologists, etc.)
• Special diagnostic procedures by specialists (e.g., EEG, cardiac echography, Fibroscan, etc.)