News Release: New Report Introduces Benchmarks on Clinical Trials Vendor Qualification Process
January 9, 2020 – GLOBE NEWSWIRE
PRINCETON, NJ – A new report from Tufts Center for the Study of Drug Development establishes benchmarks for the vendor qualification process, a critical element of clinical trial set up and execution. According to its November/December Impact Report, the process volume and complexity of the vendor qualification process creates delays in initiation in 7% of clinical trials for biopharma sponsors and 14% of trials for Contract Research Organizations.
The analysis, conducted in collaboration with The Avoca Group, was based on data provided by 76 small, medium, and large pharmaceutical companies engaged in global drug development.
Among the key study findings summarized in the November/December Tufts CSDD Impact Report were the following:
- In 2018, global spending for vendor qualification and requalification is estimated to be $375M, with 25,000 qualifications and requalifications conducted.
- Vendor qualification assessment costs have large disparities and variances between companies; there is a need to standardize and optimize the process.
- There is significant variation across the service provider domains evaluated; a standardized approach would greatly improve the efficiency of evaluations.
- A high percentage of assessments, especially those conducted by larger companies, include customized areas of inquiry, which create challenges to streamlining and standardizing the processes involved.
- There is no identifiable competitive advantage held by any company based on the approaches to vendor qualification examined; an industry-wide or third-party system might benefit every organization.
- Cycle times for vendor qualification are lengthy and growing; the average total cycle time from an RFI request to a signed contract is 19.0 weeks for single-service providers and 26 weeks for multi-service providers.
“Evaluating external service providers is a time-consuming process that must meet the unique demands of each R&D program and account for, among other factors, regulatory compliance, risk management, cost efficiency, information technology expertise, operating, and financial controls and oversight,” said Ken Getz, principal investigator and deputy director of Tufts CSDD. “The volume and complexity of assessments needed to qualify and requalify potential vendors is increasing, and the benchmarks from this new study identify opportunities for drug developers to more effectively and efficiently manage this process.”
“The development of our new Diligent® Qualification Platform aligns with the vision we share with our partners to bring optimal efficiency and effectiveness to the quality and compliance elements of the clinical development process. With Diligent’s intuitive technology and suite of quality assurance assessment and auditing services, sponsors and CROs can rapidly identify, evaluate, and select clinical service providers,” said Patricia Leuchten, Founder and CEO of The Avoca Group. “Diligent accelerates the prequalification of clinical service providers by leveraging powerful analytical technology and industry-leading standards from the Avoca Quality Consortium®. Clients have seen significant reductions in vendor qualification cycle times, in most cases from weeks to days, using the Diligent Platform.”
For more information, contact Mark Engelhart at mark.engelhart@diligentpharma.com.
Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums, and publishes Tufts CSDD Impact Reports, a bi-monthly newsletter providing analysis and insight into critical drug development issues.
About The Avoca Group
The Avoca Group is a life science consulting firm dedicated to improving quality and compliance in clinical trial execution. Since 2011, the Avoca Quality Consortium, a collaborative of over 100 pharma, biotech, CRO, and clinical service provider companies, has led the industry in developing practical solutions for improving quality and execution in clinical trials. Companies benefit from Avoca’s insightful research, deep subject matter expertise, industry-leading approaches, and technology. Avoca offers platforms and tailored solutions to help clinical research companies increase quality, ensure compliance, and improve efficiency so that medicines can reach patients faster.
About the Diligent Qualification Platform
The Diligent Qualification Platform is a groundbreaking cloud-based technology platform as a service (PaaS) that streamlines and simplifies provider selection and qualification. Diligent makes identifying, evaluating, and selecting clinical trial providers more efficient and less expensive and meets today’s rigorous quality and compliance standards. Built on The Avoca Group’s extensive industry standards for clinical service provider qualification, Diligent meets the demands of today’s changing clinical trial landscape.