Mediconomics GmbH

Mediconomics is a full-service CRO and pharmaceutical consultancy providing services for research and development projects involving pharmaceuticals, medical devices, and developmental candidates. With over 25 years of experience and certified according to DIN EN ISO 9001:2015, we cover all areas required for regulatory approval.

We offer services for all phases of clinical trials (Phases I-IV), including study design, application submission, monitoring, regulatory support, and statistics. Our experienced team ensures that your clinical studies are conducted efficiently and in accordance with the highest standards.

We combine medical and scientific expertise with economic efficiency to offer tailored solutions. As a small yet flexible company, we adapt seamlessly to your specific requirements.

Mediconomics offers comprehensive pharmacovigilance services to monitor the safety of medicinal products post-approval. We continuously collect and analyze safety data to gain new insights into safety profiles and meet regulatory requirements. We provide a Qualified Person for Pharmacovigilance (QPPV) as needed, maintain Pharmacovigilance System Master Files (PMSFs), and operate safety databases.

Mediconomics provides comprehensive clinical data management services, including eCRF design, coding, query management, and meticulous quality control. We ensure that your data is of the highest quality, reliable and trustworthy to enable robust scientific analysis.

Yes, our medical device experts assess compliance with relevant regulations, standards, and guidelines. We accompany the entire life cycle for market approval in collaboration with our sister company Medicoforum, a medical device manufacturer.