The Diligent Prequalification Platform, which uses analytics-driven technology and industry-accepted standards to provide quick access to RFI (request for information) questionnaires, is supported by sponsorship commitments from Purdue Pharma, Sanofi, and Seattle Genetics.
The technology will be released later this year though many of the services are currently available.
The sponsor companies will also help direct the platform’s expansion beyond endpoint generating technical services to more functional contract research organization (CRO) service categories, such as data management, field monitoring, and biostatistics, according to the organization.
Dennis Salotti, vice president, operations, The Avoca Group, described Diligent as a vendor selection decision support tool in its earliest stages.
“The immediate benefit of Avoca bringing this infrastructure for qualifying clinical service providers to industry is that it brings liquidity to information, making it move more efficiently between parties,” he told us.
“But the near-term gains in reduced time and cost, while valuable, aren’t where the transformational value of Diligent lies. Rather, it lies in the longer-term opportunity to understand what elements of due diligence and qualification truly have meaningful impact to service delivery and quality.”
As Salotti explained, the tool enables users to synthesize centralized RFI information with other data sources, such as bidirectional feedback regarding the outsourcing relationship, absolute and relative spend, and other outcomes-focused data. With this, users are able to optimize vendor selection to balance quality, cost, and a program or asset’s unique requirements.
“The confluence of increased outsourcing activity, escalating regulatory expectations and an increasing velocity of innovation in these categories creates a great deal of risk when identifying, selecting and overseeing clinical service providers,” he added.
The Diligent platform is founded on standards set by the Avoca Quality Consortium, the organization’s pre-competitive collaborative made of up more than 80 biopharmas, CROs, and non-CRO service providers.
The standards were vetted by sponsors and providers and traced to the applicable regulation, guidance, or practice source, Salotti explained.
“RFI questionnaires were developed based on and traced to these standards following the same collaboration-model approach,” he added.
Participating providers complete the questionnaires which are made available to participating sponsors upon request and with permission of the provider.
"If we have the opportunity as an industry to reduce the time it takes to start a trial – perhaps in the unintuitive or less than sexy areas like reducing the time it takes to qualify a vendor with capabilities essential for a clinical trial while maintaining and arguably improving the quality of that process, we owe it to our companies, our shareholders and most of all to our patient community to make that move," said Salotti.