Calibration of equipment in clinical trials is critical for maintaining confidence in test results. It also ensures compliance with regulatory requirements from the FDA, EMA, and international standards such as Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).
It is the Monitor’s responsibility to verify that investigators have adequate resources, including properly calibrated equipment, and that essential documentation is maintained throughout the trial. Any equipment used to measure or store trial-related parameters—such as refrigerators, freezers, centrifuges, blood pressure devices, infusion pumps, and balances—must undergo calibration before use to confirm accuracy. Without this step, trial data may not meet the required standards of reliability or compliance.
LABFISH meets this need with the largest in-house calibration facility in Europe. The facility specialises in temperature calibration for medical storage units, data loggers, and centrifuges. This service is backed by over 20 years of expertise and operates under an ISO 9001 quality management system.
Initial calibration is only the first step. Regular recalibrations are essential to maintain accuracy. For many devices, a one-year interval is generally accepted, but this can vary depending on regulations, manufacturer guidelines, or the required level of confidence in the data. Legal requirements also differ between countries and equipment types, so users must carefully check the relevant standards. LABFISH’s in-house capability allows rapid turnaround, helping clinical sites stay compliant and operate efficiently.