We offer our clients the whole range of services in the field of clinical development, medical affairs and post marketing surveillance for single products and projects or the whole portfolio including traditional drugs, vaccines, herbal products and orphan drugs:

• Strategic analyses of clinical portfolios including outline of future development of e.g. new indications.

• Compilation of protocols and study synopsis according to ICH-GCP guidelines and Austrian Drugs Act (AMG)

• Biometry and Preparation of Case Report Forms

• Compilation of patient information and informed consent

• Inquiries of insurance confirmation according to AMG

• Performance of feasibility studies in respect to clinical development of a product (selection of study sites, patient groups, etc.)

• Recruitment of trial centers

• Reporting to the relevant Austrian health authorities & ethic committees

• Supply of request for trial medication by the trial centers and submission for an import license for trial drugs

• Drug Accountability and destruction of residual medication

• Production of supporting materials (labels, etc.)

• Initiation, Clinical Monitoring and Termination

• ICH-GCP reporting  like preparation of Final Study reports

• Preparation for publishing

• Endorse the clients in all enquiries about quality in performance of clinical trials (GCP) up to audits as assessment of considered CRO`s or of centers (on-site-audit), etc.