PK Reports for Bioequivalence Studies in just 24 Hours from Concentration Data Upload

CRST’s bioequivalence package offers PK reports for bioequivalence studies in just 24 hours from concentration data upload. Bioequivalence testing of drug products is conducted in compliance with Good Clinical Practice and EMA’s Guideline on the Investigation of Bioequivalence. BE studies are conducted effortlessly with competitive pricing with CRST’s full-service trial package:

• Clinical study protocol and report writing
• Regulatory submissions
• eCRF
• Clinical conduct with efficient recruitment of healthy volunteers
• Study monitoring
• Project management
• Analysis of PK samples in our in-house GLP-accredited bio-analytical laboratory
• Data management in collaboration with our partner StatFinn Ltd.
• PK calculations and statistical analysis by StatFinn Ltd. with eBESTbio, a cloud reporting tool to create a PK report in just 24 hours from the concentration data upload.

For more information or to discuss bioequivalence studies please contact us directly.