From the early 1990s Henning Blume and Barbara Schug, the founders of SocraTec R&D, have been involved in the scientific discourse regarding when drug-drug interaction (DDI) studies are meaningful and necessary. In the meantime, tremendous progress has been achieved, predominantly influenced by increased knowledge about absorption and metabolism as reflected by the current EU and US guidelines.
These requirements are an integral part of SocraTec’s knowledge and experience.
Drug compound or drug product characteristics? Whatever the question you are dealing with – our experience covers both and helps to find the best solution for your approval process.
Sometimes these investigations need to be realised in patients, depending on the safety profile of your product. We help you to find and implement the appropriate solution. Our experience with patients in phase I is your advantage when realistic approaches being finally accepted by authorities are needed.
Our recruitment is based on a vast network of referring physicians within Thuringia and Hesse. This concept allows quick recruitment of symptomatic patients under standard therapy, for example for DDI studies in oncology.
Our study nurses in our phase-I team are highly experienced in conducting complex and highly standardised trials. Our dieticians are experts in developing menus which fulfil authorities’ requirements and at the same time find acceptance by trial participants.
Our staff’s experience is your advantage.