Benchmarking the Vendor Qualification Process.

The vendor qualification assessment (VQA) process is regarded as expensive and time consuming but there is no quantitative data characterizing and benchmarking this process. The Tufts Center for the Study of Drug Development (Tufts CSDD)-in collaboration with the Avoca Group and 13 pharmaceutical, biotechnology and contract research organizations-conducted a survey of 120 unique companies to gather baseline data. The study results confirm that companies are investing substantial time and resources to support a high and growing volume of vendor qualifications and re-qualifications each year. The average total time to perform a vendor qualification is almost 5 months for single service providers and nearly 7 months for multi-service providers with wide variation within and between companies observed. Re-qualification cycle times are only marginally faster although, in theory, experience and familiarity with a given vendor should replace some assessment requirements. Significant differences were observed by company size and type. A high percentage of assessments-most notably those conducted by large companies-involve customized assessment areas. CROs are able to perform the VQA process significantly faster with fewer personnel. Based on the data provided, Tufts CSDD estimates that global drug developers spent about $375 million to perform approximately 25,000 new vendor qualifications and re-qualifications in 2018.

Canadian Association for Immunization Research and Evaluation (CAIRE) guidelines for industry-sponsored clinical trial and epidemiology contract research.

In response to concerns about interactions of academic and public health investigators with industry, the Canadian Association for Immunization Research and Evaluation (CAIRE), in collaboration with six major vaccine manufacturers, developed guidelines for participation in industry-sponsored clinical trial and epidemiology contract research within Canada. Topics addressed include definition of investigators, data ownership, protocol development, data management, data analysis, producing a study report and publication of the results of the study.