The Avoca Quality Consortium (AQC) summit took place this year in New York on May 10th and 11th.
To learn more about how the Avoca Group is addressing industry challenges, Outsourcing-Pharma.com talked with Avoca CEO Patricia Leuchten.
At this year’s meeting how did some of the key themes vary from previous years as the industry continues to evolve and face new challenges?
This year’s theme was Changing Landscapes: Shape the Future of Clinical Trials.
We meant “Changing” in two senses – as an adjective and verb. While the landscape is always changing, the pace of change has become especially rapid today.
Compared to five years ago, we’re further along in terms of using technologies with industry alignment on electronic data capture, yet with opportunities to gain greater alignment on electronic health records (EHR) and the use of mobile devices. And in ways we hadn’t before, we’ve begun to envision how to more effectively engage patients.
These changes in the landscape empower us as an industry to make “changing” a verb by proactively improving our approach to quality. As a Consortium, we’re going to continue to develop and share leading practices in a pre-competitive environment – a must to enable transformative change.
What are some of the regulatory changes currently being stipulated for which Avoca has been calling?
Our vision has always been that the industry take a proactive approach to quality, risk management, and provider oversight. We believe we should “slow down to speed up” and do things right the first time: assess and address the risks that matter most to patient safety, data integrity, and the ability to interpret clinical results.
We’ve long encouraged a proactive approach to managing risk. We believe the recently issued ICH E6 R2 guidance reinforces and aligns with the long-standing Avoca Quality Consortium (AQC) approach that will help make that vision a reality.
How has the Avoca Group worked to advance some of these changes?
At the AQC Summit this year we unveiled our regulatory roadmap which aligns our AQC leading practices to ICH E6 R2 in the form of a “treasure map.”
We’ve refined our eight-component framework for oversight and also enhanced other AQC leading practices. They have become a “recipe book” that sponsors can adapt based on their outsourcing model
What do you expect from the next five years?
We’re going to see even more engagement as new and different kinds of companies join the Consortium. We’re going to take the collaboration model to the next level and see member companies adopting and incorporating leading practices into their day-to-day behaviors and culture.
And at the AQC, we’re going to continue to centralize business processes that are currently dysfunctional or redundant – along the lines of how we’ve streamlined the qualification of technical service providers with our Diligent Prequalification Platform. As we do so, Member engagement and feedback will continue to be critical.
As it pertains to the industry, what keeps you up at night?
Inefficiency in clinical trial execution, which will ultimately delay getting medicines to patients. It makes the trial process slower and more expensive. Duplication of efforts and siloed approaches threaten to hold us back. There are practical solutions and better ways forward available to the industry already.
With Members and external groups, Avoca is working to put solutions forward. Sometimes, all that is required is a change in mindset and the courage to take the first step.