Quality management system

CRST is working under a SOP based quality systems. The main guidance followed is ICH GCP, with highly skilled professionals in QA and QC positions. All clinical personnel are required to be GCP trained. Our internal audits are used to ensure the high-quality level. The quality assurance (QA) is placed as a single unit in CRST, which enables independent quality control of CRST.

Scientific excellence

CRST’s aim is to provide its customers state-of-the-art solutions based on the most recent scientific knowledge. Our competence stems in part from networking in order to establish the required expertise and technologies, allowing us to serve all areas of clinical drug research as a single organization.

Clinical trials professionals

CRST’s core study teams have extensive experience in conducting early-phase clinical trials according to GCP guidelines since 1996. Over the years, we have developed the knowledge and skills to employ flexible study designs and a wide spectrum of surrogate endpoints designed to capture maximal information on the safety and pharmacological effects of the investigated compounds.

Based on close cooperation with the Medical Faculty of the University of Turku and with Turku University Hospital, CRST has direct access to a wide network of clinical specialists in almost all therapy areas.

PET imaging & tracer development

Clinical study approaches using PET imaging can provide significant benefits in the early development of a drug candidate, including the potential to obtain information on

• the mechanism of pharmacological action – evidence of target engagement
• subject selection and stratification based on imaging biomarkers
• the possible therapeutic dose range (dose-effect relationships, e.g., receptor occupancy)
• biodistribution of a radiopharmaceutical in different organs and tissues in vivo

PET imaging provides information to support the therapeutic and/or diagnostic rationale of your candidate molecule. CRST has a long history of close collaboration with Turku PET Centre (see https://turkupetcentre.fi/) in PET imaging and tracer development projects.