CRST’s aim is to provide its customers state-of-the-art solutions based on the most recent scientific knowledge. Our competence is based on 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 team has extensive experience in conducting Phase I and II clinical trials according to GCP guidelines since 1995. During these 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 efficacy of the investigated compounds. Examples of studies conducted include
Drug interaction studies, for example, on various CYP450 isoenzymes
Food interaction studies
PK and bioequivalence studies
Maximum tolerable dose studies
Single and multiple ascending dose studies
Occupancy, PK and safety studies using PET
First-in-man dosing of NCEs, biological drugs and vaccines in healthy volunteers and patients
Based on close cooperation with the Medical Faculty of the University of Turku and 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 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 history of close collaboration with Turku PET Centre in PET imaging and tracer development projects (see our examples).
Turku PET Centre is an internationally recognized Centre of Excellence in the use of short-lived positron emitting isotopes in biomedical research, with a history spanning more than three decades. Its facilities include state-of-the-art PET, PET/CT and PET/MRI imaging instrumentation, accelerators and radiopharmaceutical chemistry laboratories. A wide selection of tracers is produced on-site. Combined with CRST’s strong regulatory and GCP competence and scientific and clinical strengths, this environment offers unique possibilities for clinical trials applying PET imaging.
Adaptive study designs
Adaptive study designs in Phase I and II clinical trials increase the potential to gain information in an expedited manner in comparison to classical rigorous early-phase study designs. Separate, multiple study protocols and Ethics Committee and regulatory approvals may require several months’ passive time that can be avoided with a single adaptive protocol, possibly supplemented with interim reports and protocol amendments.
CRST’s core study team has extensive experience in conducting Phase I and II clinical trials according to GCP guidelines since 1995. During these 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 efficacy of the investigated compounds.
CRST has the capacity to recruit healthy volunteers and outpatients within agreed timelines, even for some very challenging types of studies. CRST is located on the campus of Turku Science Park, within a few blocks from the University of Turku and Turku University Hospital. This makes CRST’s location ideal for subject recruitment. Turku’s student population of over 30 000 provides a large, renewable pool of healthy young volunteers.
The catchment area of Turku University Hospital has about 700 000 inhabitants. Patient populations may be further expanded through cooperation with the neighbouring Hospital Districts. The uniform, high-level public health care system of Finland and the research-friendly attitude of its population provide good prerequisites for clinical research. Protocol adherence and treatment compliance are usually excellent.