Clinical trials monitoring

Synavia provides monitoring of various types of pharmacokinetic (PK) trials with appropriate emphasis on the role of bioanalytical method. 

Clinical monitoring reflects

• Experience with different types of  PK  studies, such as bioequivalence, food-effect studies, interaction studies, dose proportionality as well as animal toxicokinetic studies.
• Knowledge of specific issues occurring during the execution of different drug form studies, such as  oral solids and suspensions, inhalation preparations, patches.
• Up-to-date knowledge of the inspection history of CROs in different regions.
• Up-to-date expectations of regulatory authorities from the QA point of view (GCP, GLP, GDP).
• Robust internal QA system in place, but also flexibility to follow the sponsor´ s SOP.

Bioanalytical monitoring

We see the bioanalytical part of the study as equal to the clinical one in terms of its importance leading to regulatory assessment as regards the safety and efficacy of drug products.  We therefore check thoroughly, if the bioanalytical methods used are well characterised, appropriately validated and documented.