In our Decentralized Model, the laboratory part of a multinational clinical study is managed and executed in a locally-based facility, selected by taking into consideration the study sites location, sample stability, transport requirements and national regulations. All logistical and diagnostic procedures are performed in exactly the same way across the facilities and the clinical trial laboratory data are automatically transferred from all lab locations to a single study-specific database, designed and validated to provide access to standardized and consistent data at the end of the study.
The main advantages of our decentralized approach for the clinical trial sponsors are:
● Significant logistic costs reduction of clinical study lab supplies and samples due to decreased number of inter-country shipments. Especially when we take into consideration dry ice shipments, savings are estimated at a level of 30 to 50%. With the current increase in complexity of clinical trials, more specialized tests are required to be performed during the study e.g. there is a significant increase in frozen shipments.
● Faster access to laboratory results due to shorter sample turnaround time (TAT). The study specimen is sent to a locally-based central lab for analysis, as opposed to a global central lab located potentially several thousand kilometers away from the site. On special request we can organize access to results after 24h, from the sample collection; this is dependent on the site location and the type of test.
● Harmonized clinical laboratory data, from all lab facilities that have been involved, are provided at the end of a clinical study in one-single and standardized database in a format requested by the client. The clinical trial lab results are automatically sent from each location during the trial to a study-specific “global” validated database. So the final product is the same as it is in case of a study with a “regular “central lab(one location) but the study cost-saving are significant
● Real-local support for investigator site personnel and regionally-located sponsor’s study teams thanks to our locally-based staff who provide support in their native language, understanding their culture and providing expertise with regards to national laws, regulations and requirements. Thus saving valuable time in clinical trials, needed for : Interpreting lab results correctly; solving daily study-related queries or kits and study materials re-supply.
● Access to emerging markets of Central and Eastern Europe that are still not utilized to their full potential. These countries, like Georgia, Moldova, Serbia and Bulgaria provide access to naive drug patients, centralized healthcare systems, well-educated and motivated investigators and overall competitive study logistic costs.