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.

中文翻译：

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对供应商资格流程进行基准测试

供应商资格评估 (VQA) 过程被认为既昂贵又耗时，但没有量化数据表征和衡量该过程。塔夫茨药物开发研究中心 (Tufts CSDD) 与 Avoca 集团和 13 家制药、生物技术和合同研究组织合作，对 120 家独特的公司进行了调查，以收集基线数据。研究结果证实，公司每年都在投入大量时间和资源来支持大量且不断增长的供应商资格认证和重新认证。单个服务提供商执行供应商资格认证的平均总时间接近 5 个月，而多服务提供商则为近 7 个月，观察到的公司内部和公司之间的差异很大。重新认证周期时间只是稍微快一点，但理论上，对给定供应商的经验和熟悉程度应该取代一些评估要求。公司规模和类型存在显着差异。很大比例的评估——尤其是那些由大公司进行的——涉及定制的评估领域。CRO 能够以更少的人员显着更快地执行 VQA 流程。根据提供的数据，Tufts CSDD 估计全球药物开发商在 2018 年花费了大约 3.75 亿美元来执行大约 25,000 个新供应商资格和重新资格。很大比例的评估——尤其是那些由大公司进行的——涉及定制的评估领域。CRO 能够以更少的人员显着更快地执行 VQA 流程。根据提供的数据，Tufts CSDD 估计全球药物开发商在 2018 年花费了大约 3.75 亿美元来执行大约 25,000 个新供应商资格和重新资格。很大比例的评估——尤其是那些由大公司进行的——涉及定制的评估领域。CRO 能够以更少的人员显着更快地执行 VQA 流程。根据提供的数据，Tufts CSDD 估计全球药物开发商在 2018 年花费了大约 3.75 亿美元来执行大约 25,000 个新供应商资格和重新资格。