SocraTec R&D is a full-service CRO (Contract Research Organisation) in the field of pharmaceuticals and medical products. Our own Phase-I/II Units, along with our project management and monitoring teams, allow us to conduct clinical research from the first application in humans, through proof-of-concept in the patient population, to efficacy proof in the late stages of clinical testing.

Our experienced specialists develop your approval and study designs, plan and realize your clinical trials, and accompany you scientifically and technically from drug form and device development to the approved product.

SocraTec R&D was founded in 1998 and has from the outset been characterized by a high demand for quality and science. Because of an intense exchange with regulatory authorities worldwide, targeted solutions for the approval processes of our customers are possible. An experienced team of project managers, monitors, auditors, trial doctors, study nurses, and medical writers with high regulatory, medical and pharmaceutical competence, along with an efficient organizational infrastructure, support our customers in the realization of their research projects.

socratec-pharma.de


By having ESG as a fixed part of our business model, we reduce risks, drive long-term value creation, and promote sustainability.


WHAT WE STAND FOR

  • Scientifically sound solutions and perfect study designs
  • Professional study execution and passion for quality
  • Experience and continuity
  • Transparency and reliability
  • Creativity and pragmatism


WHAT WE DELIVER

  • Clinical development plans and study design development
  • Full accompaniment of Scientific Advice procedures in the EU and at the FDA
  • Project management including Regulatory Affairs / CTIS submissions for clinical trials
  • Monitoring of clinical studies from Phase I to Phase IV
  • Auditing both as system and study audit with a focus on GCP, GLP, PV, and GMP-Annex 13
  • Medical Writing from the technical document to science communication

FULL-SERVICE FOR

  • Early phase trials from first-in-human to large bioequivalence studies in 2 own CPUs tailored to different needs in Erfurt
  • Phase-II patient studies with access to the patients of the large maximum care hospital with 1,300 beds and 30 clinical departments in Erfurt
  • Phase III and IV studies in Germany and together with our partner companies throughout the EU and the USA

SocraTec R&D News