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Pharmacokinetic and Bioequivalence Studies
CRST provides a full range of services for Pharmacokinetic and Bioequivalence studies conducted by our experienced team of scientists. All our procedures and reporting are conducted in accordance with GCP guidelines.
CRST has the facility to offer 2 fully equipped 8 bed wards with experienced clinical staff who provide a 24/7 service. We also offer an in-house GLP accredited bio-analytical laboratory for drug assays.
Pharmacokinetic and Bioequivalence Studies Full Service Package includes:
• Medical and scientific consultation throughout the study
• Study design planning
• Medical writing: protocol, informed consent and other required documents, study report, translations
• Regulatory submissions: preparation of documents, submissions and correspondence with the Finnish Medicines Agency (Fimea) and the Ethics Committee
• CRF and source data form design
• Subject recruitment
• Clinical conduct of the study
• Study monitoring
• Project and site management
• Analysis of PK samples
• Data management and statistical analysis (through our partners)
For more information or to discuss Pharmacokinetic and Bioequivalence studies please contact us directly.