Clinical Research for Pharmaceuticals and Medical Devices

• 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 writing the report.
   
• 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
• Help to select the clinical centres and to plan the logistics
• Contact to 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) 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. 15 years experience with the realisation of clinical studies.