Clinical studies
Apomedical LLC has a special Department for clinical material which is regularly subject to strict controls to ensure proper storage of medical products for research purposes and other material intended for clinical studies.
Our commitment to carefully sourcing clinical material ensures that possible contamination or errors are avoided throughout the process.
A clinical trial of drugs is any trial on humans with the aim of determining or confirming the clinical, pharmacological and/or pharmacodynamic effects of one or more tested drugs, identifying adverse reactions to one or more tested drugs, as well as the clinical part of researching the bioavailability and bioequivalence of one or more tested drugs with the aim of determining their safety and efficiency. The clinical trial should be conducted in accordance with the ethical principles derived from the Declaration of Helsinki, according to the guidelines of Good Clinical Practice, the International Conference on Harmonization and current regulations.
Our services include:
- Receipt of clinical trial materials
- Review inventory discrepancies, damaged boxes, or broken fasteners
- Transfer of materials for the clinical study to the test site
- Returning clinical study materials from the test site
- Redistribution of returned medical products for research purposes
- Resolving deviations / non-compliance and complaints
- Backup plan in case of deviations in temperature
- Backup plan in case of fire