The clinical trial process is a key component of the $2.6 billion it costs, on average, to roll out a new medicine. Clinical trials are highly regulated medical research studies designed to evaluate the impact potential new medications have on patients. There are currently more than 365,000 clinical trials underway in 219 countries worldwide.

The Avoca Group started as a boutique consulting firm working with leading pharmaceutical companies on quality and compliance in clinical trial execution. Early on, founder and CEO Patty Leuchten recognized that, from an industry perspective, “there was inefficiency and a lot of reinventing the wheel” going on.

That constant, and unnecessary, reinvention was slowing progress toward getting new medicines to patients that needed them.

“We took a step back and observed that perhaps we, as an industry, could make greater progress through collaboration,” Leuchten says. So, she proceeded to connect with the heads of clinical operations and quality management at the bigger companies to propose that, together, they could move the industry forward more quickly. Although there are parts of the process that are confidential and proprietary to individual companies, she acknowledges, the approach to quality should not be. By collaborating, the industry as a whole could make it possible to develop medicines faster and safer.

COLLABORATE TO INNOVATE

The Avoca Quality Consortium was launched in 2011 with Pfizer and Eli Lilly & Company as the first members. “It was an inflection point for our company,” Leuchten says. Rather than being limited to providing consulting services for individual pharmaceutical companies, Avoca could serve a wider spectrum of industry players and have a larger impact.

Some of the first initiatives within the consortium focused on quality agreements and metrics, followed by developing proactive risk management tools and leading practices for ensuring protocol quality. This has led to the 2021 efforts to provide support to clinical research sites and to move toward greater diversity in clinical trials.

Today, there are more than 130 member companies, including pharmaceutical sponsors, contract research organizations, clinical service providers, sites, and other organizations engaged in clinical trial execution. As consortium members, organizations can participate in leadership advisory boards, working sessions, networking events, and educational webinars. They can also tap into more than 500 published tools, guidelines, approaches, standards, and

templates focused on proactive quality and risk management and leverage quantitative and qualitative data from across the industry.

ACTIVATING CHANGE

Building on the success of the consortium, Avoca has debuted the Avoca Innovation Alliance, which was formed to enable breakthroughs for next-generation clinical trial execution by focusing on how to operationalize innovations.

“Our mission is to have a positive impact on all clinical trials, by helping clinical research companies increase quality, ensure compliance, and improve efficiency so that medicines can reach patients faster,” Leuchten says.