Clinical Research for Pharmaceuticals and Medical Devices

We can support you during the steps of product development and certification considering the scientific basis, the guidelines, the standards and legal environment.

• Preclinical research for medical devices
• planning on basis of own animal-surgical experiences
• scientific study design, and statistic and logistic planning
• drafting of the study plans, applications, CRF and other documents
• evaluation of study results and report writing
   
• Planning and design of international clinical studies
• for pharmaceuticals (clinical studies phase II-IV)
• and medical devices (all phases)
• scientific study design, statistical and logistical planning
• drafting of the study plans, CRF, patient information, and other documents
• with competence in internal medicine, cardiosurgery, neurology / psychiatry, immunology, transfusion medicine, microbiology, dermatology, and radiology
   
• Implementation and Management of Clinical Studies
• support you to select the clinical centres and to plan the logistics
• contact investigators, Ethics Committees, government and Notified Bodies
• quality assurance, auditing according to Good Clinical Practice (GCP)
   
• Data Management
• appropriate planning of the data acquisition and management
• peculiar multilingual Internet-based remote data system eCRF^.uk with SQL data base,
• online randomisation, online data validation and real-time status data
• ensuring better data quality and rendering possible timely completion
   
• Evaluation of Study results
• statistical evaluation using standard software ( sas^®)
• writing biometrical and clinical study reports, as well as expert reports,
• based on the study protocol, ICH, and SOPs
   
• Expert reports and clinical evaluations for medical devices
• on basis of own medical and pharmacological experiences
• on basis of own experiences as industrial designer
• on basis of ca. 20 years experience with the realisation of clinical studies