Synevo Central Labs, as a reaction to today's clinical trial environment, has successfully created the largest network of central laboratories in Europe and offers centralized regional laboratory services to clinical trial sponsors, also known as Decentralized model. This new approach is a very time and cost effective solution.
In our Decentralized Model, laboratory part of a multinational clinical study, is managed and executed in our locally-based central laboratories, 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 benefits of the decentralized approach for the clinical trial sponsors are:
- Significant logistic costs reduction of clinical study lab supplies and samples due to decreased number of intercountry shipments. Especially when we take into consideration dry ice shipments, we are talking about saving at a level of 30 to 50%. And with today’s market trend of increasing complexity of clinical trials, means more specialized tests are required to be performed during the study, frozen shipments are becoming more and more common.
- Faster access to laboratory results due to shorter sample turnaround time (TAT). The study specimen is sent to locally-based central lab for the analysis, and to a global central lab located even several thousand kilometers away from the site. For special request we can organize access to results after 24h, from the sample collection, but it depends on sites 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 a 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 “regular” (one location) central labs but the study cost-saving are undeniable.
- Real-local support for investigator site personnel and regionally-located sponsor’s study team thanks to our locally-based staff which support them talking the same language, understanding the culture and providing expertise with regards to national laws, regulations and requirements. So, we save very precious time in clinical trials, needed to e.g. interpret lab results correctly; solve daily study-related queries or kits and study materials re-supply.
- Access to large patients population of Central and Eastern Europe that are still not utilized to their full potential. These countries, like Russia, 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.