SocraTec R&D stands for sound clinical research, innovative study designs and precise implementation

We combine scientific depth with precise clinical implementation: As a specialised service provider, we plan, manage and implement studies from early clinical development through to approval. Our teams develop study concepts, draw up study plans, take on monitoring, project management and medical-scientific consulting – always in accordance with the highest quality and GxP standards.

With two Clinical Pharmacology Units – a central CPU with 54 beds and flexible room units as well as another unit in the hospital environment – we offer optimal framework conditions for first-in-human studies, SAD/MAD designs, food effect studies and bioequivalence studies. Pharmacokinetic and pharmacodynamic concepts can also be realised in all degrees of complexity.

In later phases, we support multicentre and multinational studies from Phase II to IV, including PASS, PAES and DUS projects. Thanks to close collaboration with our sister companies, data management, biometrics and pharmacovigilance are seamlessly integrated.

With many years of experience, our own infrastructure and a high level of methodological expertise, we lead challenging research projects to success in a targeted, safe and efficient manner.

Our focuses

Early phase studies (Phase I)

Our clinical unit specialises in first-in-human studies – including SAD, MAD and food effect studies. We conduct bioavailability and bioequivalence studies in various dosage forms and realise pharmacokinetic and pharmacodynamic concepts through to integrated protocols with patients.

Clinical development phase II-IV

Phase II to Phase IV projects are fully supported – from planning, site selection and monitoring to data management, statistics and medical writing. We implement multicentre and multinational studies (PASS, DUS, PAES) throughout Europe and worldwide, with high quality and clear processes.

Main CPU: capacity and flexibility

Our central Clinical Pharmacology Unit offers 54 beds on 1,400 m² and flexible room concepts for a wide variety of study designs. An experienced clinical team ensures efficient processes, precise data collection and the highest safety standards.

Additional CPU in the hospital environment

Additional study capacities with six beds are available in another CPU integrated into the maximum care hospital. The proximity to the intensive care unit and anaesthesiology offers maximum medical safety – even for demanding or high-risk study concepts.