About

SocraTec R&D, a mid-sized clinical CRO was founded in 1998. From the beginning the company was dedicated to early phase clinical trials in healthy volunteers, extending the activities towards patients and later phases during their history. The key staff members of the company have far-reaching experience from many years in drug research and development.

From the beginning SocraTec R&D was set-up with a modern quality Quality Management management concept strongly influenced by GLP- and GCP-principles. All processes are embedded in a comprehensive Quality Management under the supervision of a highly experienced and independent QA-group. Biometric services follow the standards of 21 CFR Part 11. SocraTec R&D is frequently audited by all types of pharmaceutical companies and has been inspected by national EU-agencies, EMA and FDA as well as by ANVISA.