Management of Studies

Organisation: Eurofins' teams work closely with our clients through a collaborative approach, supported by qualified and experienced project managers.

Documentation: projects can be tailored to meet specific requirements and are managed by means of tailored, customised documentation: study protocol, final report, results tables at each deadline with trend monitoring. Stability studies are managed in our lims (eLIMS BPT), enabling our customers to monitor them continuously via our LABAccess platform.

Study design: drawing on their extensive experience, our specialists can help you create or optimise the design of your stability studies.

OOS/OOT management: stability studies are conducted within a GMP/FDA framework. This quality management enables out-of-specification and/or out-of-trend results to be managed as closely as possible to the understanding of the project and depending on the stage in the life of the medicinal product (development, clinical, submission of marketing authorisation application, marketing, etc.).

Interpretation of trends: once the stability results have been obtained, Eurofins assists you in the statistical evaluation of the data obtained at the various time points and storage conditions, and helps you interpret the trends.

This assessment covers:

• OOS, OOT, Exception
• Extrapolation
• Shelf life, expiry/pre-expiry date
• Specification review
• ICH Q1D/VICH GL45: Bracketing and matrixing designs for stability testing of drug substances and drug products
• ICH Q1E/VICH GL51 : Evaluation of stability data

Guideline reference: ICH