Clinical Operation & Regulatory Affairs Support


Many years of experience in international drug development provide the basis for our consulting activities.

Clinical Operations / Sponsor Representation

We manage your study as if it were our own. We represent your goals and interests to all stakeholders of your study.

We rely on transparency, open communication with the members of the project team, a structured approach with clear target agreements and effective target control.

Clinical Trial Liaison

Continuous motivation and scientific support of the study team are essential prerequisites for fast patient recruitment and high data quality.
We support the investigational site as well as CRA / Monitor to make your study a success.

Medical Writing / Regulatory Affairs Support

We are experienced in presenting data for regulatory purposes and medical information according to the required purpose. This includes the preparation of expert reports for regulatory applications as well as the presentation of study results in different ways.

Quality Assurance Services

Based on our many years of experience in quality assurance and auditing clinical studies according to ICH-GCP at home and abroad, we support you in the area of quality assurance.