AstraZeneca (AZ) leveraged a robust standards program to help bring its clinical trial monitoring force in-house—speeding the process and helping to get it right the first time, says Doug Schantz, Executive Director, US Site Management and Monitoring. “We decided to use competencies proactively, rather than applying them reactively,” he explains.
A year ago, AZ didn’t have in-house monitors, but made the strategic decision to make a change. At the end of 2016, the US Site Management and Monitoring group received endorsement from its global medicine development leadership to internalize its monitoring force.
“We’re building a monitoring force from zero people last year to more than a hundred this year,” Schantz says. “I’m guessing we’re different than other groups implementing the competencies because others already had an established monitoring force.”
Related: Core Competency Framework for Clinical Trial Monitoring – Clinical trial monitoring requires new knowledge, skills, and abilities. If you are responsible for monitoring conduct, interacting with monitors, or if you want to become a monitor yourself, you need to prepare today by understanding the core competencies required for monitoring. Learn More >>
As part of its transition to internal monitoring, AZ launched a training series based on its core competencies. It will also conduct monitor/clinical research associate (CRA) assessments twice a year.
AZ is applying the standards to inform the assessments in several ways. “We’ve already used standards to develop our U.S. CRA training plan,” Schantz notes. They are also planning to conduct a training assessment for study team leads and senior CRAs. “We’re using our standards and we’re going to pull people up to standard,” as identified by testing competency levels. Where there are gaps, he adds, AZ will come up with tailored training to help those who are deficient.
For example, if there is an entry-level or intermediate-level person who is unable to understand and be “conversant” in a disease or therapy area within AZ’s domain, “we would need to improve that sort of training,” Schantz says.
It’s too soon for AZ to identify gaps in terms of training, education, and experience, though. AZ started its first class in April and just brought in its third class. Those results will come, though. According to Schantz, “We’ve used the [standards] structure so that we could start to do those training assessments” more quickly than they could be done without any measurable standards.
Author: Michael Causey