Each year Halloran Consulting Group hosts‘CORE’ (Clinical Operations Retreat for Executives) as a forum for industry executives to discuss pressing challenges in a collaborative environment. This year, our Senior V.P. of Clinical Research Services, Irving Dark, discussed the topic of vendor qualification and posed the question to the group: are there better alternatives to the traditional qualification audit process? In this blog, we present Irving’s proposal for an innovative approach that could improve efficiency and allow sponsors to invest more time evaluating the operational and cultural aspects that have greater potential to ensure the success of a partnership
The Qualification Audit Today Most sponsors require CROs to undergo a qualification audit before they are able to begin working on a clinical research project. Typically, a qualification audit would include an assessment of a number of key areas including an overview of the CRO organization, a tour/assessment of its facilities, a review of the Quality Management System including a detailed review and evaluation of key documents such as Standard Operating Procedures (SOPs), CVs, job descriptions, training records, business continuity and disaster recovery plans, and data privacy/data protection policies and procedures. Computer System Validation and 21 CFR part 11 compliance are also reviewed in detail, along with the vendor’s regulatory inspection history. The sponsor auditor may also conduct interviews with key members of the vendor’s staff.
Clearly, it is vitally important that appropriate rigor is applied to the process of vendor selection and evaluation. However, there are a number of drawbacks to the existing evaluation approach.
For one, there may be substantial differences between one audit and another. Contract auditors are often used by sponsors rather than resources familiar with the company’s operational standards, which can lead to variability in the qualification process. Where specialist service providers, such as biostatistics and data management, are under consideration, auditors sometimes do not have specific domain expertise in these areas, making it difficult for them to properly assess the quality of the services to be provided to ensure compliance with benchmarks and standard processes. For both the sponsor (with many vendors to evaluate) and the vendor (with many clients arranging qualification audits), it can become a time consuming and costly process.
The key question is, does the traditional qualification process guarantee a successful engagement? Unfortunately, the answer is not always yes. Irving proposes that there may be a better way for sponsors to evaluate their CRO partners in order to optimize resources and focus attention on areas that will lead to a successful relationship.
The Alternative: A CRO Accreditation Program
Establishing a CRO Accreditation Program that defines a set of standards, through consultation with sponsors, vendors, and industry organizations such as TransCelerate, PhUSE, SCDM, MCC and PCMG. These defined evaluation criteria could include many of the aspects incorporated as part of the current individual sponsor qualification audits such as:
– GCP & ICH compliance – Global data privacy / protection compliance – 21 CFR Part 11 compliance – Business Continuity & Disaster Recovery processes – Expert review of Standard Operating Procedures, Work-instructions, and Templates – Inspection of facilities and data center(s) – Staff competency checks – Assessment of infrastructure and support functions – Review of training and development programs – Evaluation of KPIs: staff retention rates, repeat business, financial stability, etc.
Critically though, these would be assessments conducted by independent auditors to an established set of benchmarks that minimize the current variability and establish core competencies, very much like the process successfully employed within the IRB world over the past decade. Completion of a successful assessment would provide the CRO with an accreditation which could be provided to any sponsor considering entering a working relationship with them. The audit reports created as part of this process could also be made available upon request to the sponsor. Of course, to ensure up to date information, the accreditation would need to be updated regularly- nominally every two years.
This process has the potential to create more consistency across the industry and ensure that specialist services are audited by experts in their fields. Duplication of efforts would be removed, costs reduced, and the sponsor would be freed up to instead invest their resources in evaluating which CROs are likely to make the best partners.
So, with this additional capacity to evaluate the partnership potential of CROs, what should sponsors actually be looking for?
Some of the key aspects explored by Irving included:
Operational excellence and efficiencies: Evaluating the practicalities of how you would actually work together as a team. Resource management: Verifying that qualified resources will actually be there when you need them and in sufficient quantity. Values and Culture: Assessing a match of culture and values is absolutely critical and will often make a difference between a successful or unsuccessful partnership. Communication: Reviewing the proposed workflows and channels and communication. Will these work in practice for your organization? Key Performance Indicators: Developing and agreeing on a robust set of metrics for quality, timeliness, and cost will help ensure the objectives are transparent to both parties and ensure the health of the partnership. Governance: Establishing a governance structure to oversee the partnership from both sides.
The Outcomes Such a shift in the current industry practice could help to improve consistency and increase efficiency in the qualification process. It would allow both sponsors and vendors to make better use of their valuable resources and allow resources and efforts to be invested instead in getting the operational implementation right.
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About Irving Dark, Senior VP Clinical Research Services
Irving Dark brings 20+ years of business development and operational management to his leadership of Cytel’s cutting-edge biostatistics, statistical programming, and data management business. He has a track record of success in guiding drug, biologic and medical device products through the development process, and growing commercial clinical research organizations. Irving’s in-depth clinical development knowledge encompasses statistical programming, EDC and international project management. He is the co-author of numerous published clinical studies and a DIA invited speaker. Irving holds an Economics, BA from the University of Rhode Island.
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