Regulatory Guidance

Ensuring that current and relevant FDA and EMA guidances are applied to the handling of bioanalytical samples during clinical trial conduct is crucial. Validated methods that accurately reflect and respond to the storage and handling conditions of the study samples ensures reliable, accurate data will be delivered.

The FDA published guidance on bioanalytical method validation in 2018. According to this guidance, during method development, it is important to determine the chemical stability of the analyte in a given matrix, including the effects of sample collection, handling, and storage. If the storage conditions change or the sample analysis occurs outside of the validated storage conditions, stability should be re-established under the new conditions

The EMA guidance, dated 2011, states that the main objective of method validation is to demonstrate the reliability of a particular method for the determination of an analyte concentration in a specific biological matrix. If an anticoagulant is used, the validation process should be performed using the same anticoagulant as for the study samples. Evaluation of stability should be carried out to ensure that the steps taken during sample preparation and analysis, as well as the storage conditions, do not affect the concentration of the analyte.

With any bioanalytical method validation, accurate, clear, and comprehensive instruction to the sample collection sites is critical. It is vital to ensure that the requirements around collection, handling, and storage are implemented. For complex processes, or multi-site trials, the use of videos and recorded presentations can be very helpful.

Sample Handling Considerations

In this pre-recorded webinar, Annik Bergeron, M.Sc., Supervisor of Compliance and Scientific Review shares some of the important considerations that guide the handling of samples for your studies, and presents several case studies demonstrating how flexible and agile scientific approaches can improve outcomes.

  • Small molecules in plasma
  • Peptides in plasma
  • Other matrices (urine, serum, saliva)


CONTACT US for a copy of the slides, or to discuss your projects