Smooth Drug Development collaborates with several leading laboratories in Russia and Europe.
Our company provides services in central laboratory selection and management in clinical trials.
We work with laboratories that have adequate resources, equipment, personnel and quality management system covering all aspects of laboratory work. The right selection of the laboratory can be a key to clinical trials success.
A Central Laboratory is used in a trial when it is necessary to assure standardization of laboratories test results, which means to perform tests using the same methods and equipment, and when it is not possible to perform certain tests at local sites laboratories.
In accordance with ISO 9001 requirements, our company is very attentive to central laboratory selection.
Before vendor is included into our vendor list, we perform quality assessment of documentation and a vendor audit. After that, we perform regular and for-cause audits.
Together with our vendors we provide the following services:
- Laboratory selection from our vendor list
- Selection and audit of laboratories which are not included into our vendor list
- Laboratory management within clinical trials
- Biological samples export license application
- Laboratory guidelines preparation
- Site personnel training during Investigator’s Meeting
- Laboratory kits preparation, import and shipment to sites
- Shipment and export of biological samples
- Samples analysis and report preparation
- Database export for data analysis
- Quality control of documentation
Our partner central laboratories provide a wide spectrum of clinical diagnostic laboratory tests, which are performed in accordance with international quality guidelines, which guarantees test accuracy, speed and high quality.
As a leading CRO in Russia, CIS and Baltic States, Smooth Drug Development works with leading Central Laboratories in Russia and Europe.