Inc. (USA)

Driving Progress Through Collaborat­ion

A consortium model of pharmaceut­ical players helps The Avoca Group change the clinical trial execution process


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.


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.


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.

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 ??  ?? Patty Leuchten, founder and CEO, The Avoca Group
Patty Leuchten, founder and CEO, The Avoca Group

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