Abstract
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.
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References
Kaitin K. Outsourcing outpaces internal spending but remains tactical and reactive. Impact report: analysis and insight into critical drug development issues. 2019;21(2).
Brooks K. Contract Pharma’s 20th anniversary retrospective. Contract Pharm. 2019;21(8). https://www.contractpharma.com/issues/2019-10-01/view_features/contract-pharmas-20th-anniversary-retrospective/. Accessed 4 Feb 2020.
Industry Standard Research. 2019 CRO Market Size Projections. ISR Reports 2019. https://www.marketsandmarkets.com/Market-Reports/contract-research-organization-service-market-167410116.html?gclid=EAIaIQobChMIsv-r0rC45wIVmoVaBR0FygG2EAAYASAAEgKQ-PD_BwE. Accessed 4 Feb 2020.
Getz KA, Lamberti MJ. Hard truths about executing outsourcing relationships. Pharm Outsourcing. 2016;2016:18–20.
Halloran L. Revamping the vendor qualification process for clinical stage outsourcing. Clinical Leader. https://www.clinicalleader.com/doc/revamping-the-vendor-qualification-process-for-clinical-stage-outsourcing-0002 (2018). Accessed 4 Feb 2020.
Salotti D. Strategies for effective risk and capability assessments when choosing a clinical provider. Clinical Leader. https://www.clinicalleader.com/doc/strategies-for-effective-risk-and-capability-assessments-when-choosing-a-clinical-provider-0001 (2018). Accessed 4 Feb 2020.
EvaluatePharma. World Preview Outlook to 2022. https://info.evaluategroup.com/rs/607-YGS-364/images/WP17.pdf (2017). Accessed 8 Feb 2020.
Funding
Funding for this working group study was provided by 13 companies: Allergan, AstraZeneca, Biogen, EMD Serono, IQVIA, Janssen, Merck, Otsuka, Parexel, Pfizer, Tesaro Bio, Ultragenyx and Vertex. The authors thank these companies for their support of this benchmark study.
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KG, MW, JT and DS contributed to all four aspects/criteria. KR, EC and DP made substantial contributions to conceptualizing the study methods and to revising and finalizing the manuscript submission.
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Getz, K., Wilkinson, M., Turpen, J. et al. Benchmarking the Vendor Qualification Process. Ther Innov Regul Sci 54, 1349–1358 (2020). https://doi.org/10.1007/s43441-020-00157-9
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DOI: https://doi.org/10.1007/s43441-020-00157-9