Comprehensive and compliant: The quality assessment criteria used by the Diligent Qualification Platform
The Request for Information (RFI) Questionnaires used to collect information about Providers use the industry-leading standards developed by the WCG Avoca Quality Consortium (AQC) and its 200+ member companies.
Who is the WCG Avoca Quality Consortium (AQC)?
The WCG AQC is a pre-competitive collaborative dedicated to elevating clinical trial quality and bringing key stakeholders in the clinical trial process into greater alignment. Now exceeding 200 member companies (with over 9,000 member representatives), it has developed thousands of guidelines, tools, approaches, standards, templates, and metrics focused on proactive quality and risk management. The WCG AQC provider qualification standards are the foundation of the RFI Questionaries (or qualification questionnaires) used on the Diligent platform.
How are the WCG AQC standards developed?
The WCG AQC has implemented a robust, formalized process to develop and update their provider qualification tools and standards to make it easy for trial sponsors to have access to qualification tools that are based on international regulatory guidance, leading practices for quality management and general industry expectations.
The rigorous process starts with defining what is in the scope of each standard; setting definitions to clarify the language used and agreeing on expectations. Once the scope is defined, WCG Avoca works with subject matter experts to find source content for the standards – such as global regulations and guidelines, conference presentations, and white papers. WCG Avoca also conducts industry interviews with service/technology providers and their sponsor partners to gain more insight into their agreements and expectations. Existing RFI questionnaires are also donated by member companies and thoroughly reviewed by the WCG Avoca team.
Once the material is collected and a basic standard is developed, the tools are peer-reviewed by operational staff and executives. Once formalized, each standard is mapped to an RFI questionnaire. See here an example of an RFI Template of vendor qualification questions.
How are WCG AQC standards and RFI questionnaires updated to stay current?
Standards and questionnaires are reviewed regularly to identify changes that are needed, taking into account any regulatory changes, suggestions or other research by subject matter experts.
The WCG AQC standards and the RFI questionnaires support best practice and compliance because they are:
- Developed with input from AQC members representing pharma, biotech, site, CRO, and clinical service provider companies
- Detailed – but not over-specific and unnecessarily burdensome
- Cross-checked with global regulations
- Reviewed regularly for improvements and to stay up to date with industry best practices
Diligent applies WCG AQC standards to identify and manage risks of outsourced GCP services
It’s from these standards, developed by the WCG AQC members, that the quality assessment criteria Diligent uses to streamline and qualify vendors was generated. Every vendor on the Diligent platform must complete the Core RFI which is then readily available upon request by sponsors. There are also 28 service-specific RFI questionnaires (covering different service areas like patient recruitment, biostatistics, clinical monitoring, etc.) that Diligent uses to help sponsors qualify specialty service providers. This drives efficiency and gives sponsors confidence that they are correctly evaluating and qualifying the vendors through the Diligent Qualification Platform.