Harmonization process to integrate results from different laboratories to avoid possible bias generated by technical differences among local facilities
Nowadays, drug developers are strongly focused on generating more productivity from their R&D investments and allocate more resources to their outsourcing budgets. But to meet the industry demands, the sponsors need outsourcing models that can deliver higher quality and better efficiencies than traditional approaches.
Decentralized Central Laboratory Services model offers increased efficiency in terms of study budget and timelines as well as higher quality in terms of samples viability and laboratory data.
In the Decentralized model, the laboratory part of a multinational clinical trial, is managed and executed in locally-based and fully-harmonized central labs, selected taking into account the study sites location, sample viability, transport requirements and national regulations. All logistic and diagnostics procedures are performed in exactly the same way across the facilities and the clinical trial laboratory data are automatically transferred from all labs to a single study-specific database, designed and validated to provide access to harmonized and consistent data at the end of the study.
Establishing the accuracy, precision and consistency of the study samples is of paramount importance if the data are to meet the standards of international regulatory agencies. To ensure results from multiple labs will be considered viable for clinical trial purposes, Synevo Central Labs has developed a rigorous program of harmonization procedures to be used in conjunction with an ongoing interlaboratory quality control program.
Presented by
Tomasz Anyszek, MD, PhD, EurClinChem,
Synevo Central Labs Director
Tomasz Anyszek has been the Director of Synevo Central Lab since 2009 and is responsible for clinical trials operations in more than 50 laboratories in Central and Eastern Europe. Dr. Anyszek started his career with Virtual Central Laboratory, Netherlands in 2000 (Covance VCL since 2003) and his experience also includes the coordination of 16 regional Covance partner laboratories in Europe. During this period he performed about 200 audits in clinical laboratories.
Dr. Anyszek holds his PhD from Jagiellonian University, Poland. Prior to his business career, he taught clinical biochemistry and laboratory medicine at the Jagiellonian University medical faculty. Dr. Anyszek has authored more than 20 scientific publications and co-authored several books and monographies in the clinical chemistry and laboratory medicine area.
