CRST – Clinical trials with over 25 years of experience
Flexible and efficient Phase 1 trials with a proven track record
We provide full-service Phase 1 trial packages, from study design to final reports, with over 25 years of experience.
Our Phase 1 expertise includes clinical pharmacology studies in healthy volunteers and patients. Our experience and expertise allow us to offer cost-efficient and flexible services. We provide tailored service solutions, adapting to the customer’s requirements and priorities in the context of established regulatory, medical and scientific frameworks. We also provide the scientific, clinical pharmacology and clinical expertise required for successful achievement of study objectives. We have experience in small-molecule New Chemical Entities (NCE), biological drugs and vaccines.
A full-service Phase 1 CRO
We have experience in the following study types:
- Phase 1 studies
- First-in-Human (Single and Multiple Ascending Doses)
- Food effect studies
- Bioequivalence and comparative bioavailability studies
- Biosimilars
- Drug interaction studies
- Formulation studies (incl. i.v., inhaled drugs, transdermal delivery, biologicals, vaccines)
- Pharmacokinetic and pharmacodynamic studies
- Imaging studies (PET, fMRI)
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. Internal audits are used to ensure high quality.
Services:
- Study design
- Scientific consultation for drug development programs
- Medical writing: study protocol and report, informed consent and other required documents
- Project management
- Regulatory authority and ethical committee applications
- Study monitoring
- Clinical conduct, incl. subject recruitment
- IMP management and storage
- Safety laboratory testing
- Pharmacovigilance
- Bioanalytics
- Data management and statistics
- Pharmacokinetic calculations
- DSMB / Safety Review Committee arrangements
Phase 2, 3 and 4 studies
Our personnel are focused to deliver site services in Finland for your studies.
We have experience in multiple studies e.g. in the areas of CNS, cardiovascular and metabolic disorders, vaccines, gastroenterology and PET imaging.
Services:
- Project management
- Regulatory authority and ethical committee applications
- Subject recruitment
- Clinical conduct
- IMP management and storage
- Laboratory services
- Study subject questionnaires and scales (e.g. MMSE, CDR, CSSR, R-BANS)
- Imaging services (PET, MRI, CT scan)
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. Internal audits are used to ensure high quality.
Clinical studies on health foods and medical devices
CRST’s competent teams can help customers to achieve their goals with careful planning and conduct of clinical trials on health foods and medical devices. CRST can provide full-service packages for studies on health foods and medical devices, including:
- Medical and scientific consultation throughout the study
- Study design and planning
- Medical writing: protocol, informed consent and other required documents, study report, translations
- Regulatory submissions: preparation of documents, submissions and correspondence
- Case report form and source data form design
- Subject recruitment
- Clinical study conduct
- Study monitoring
- Project and site management
- Biomarker analysis (through our partners)
- Data management and statistical analysis (through our partners)