The Core Competency Framework was developed by IAOCR and the clinical outsourcing community Pharmaceutical Contract Management Group (PCMG).
“Clinical outsourcing covers an increasing range of responsibilities required in the highly regulated, demanding and competitive clinical research environment,” said Antje Hindahl PCMG Director.
However, there is currently no standard career path for this role, he said, adding that PCMG and IAOCR are trying to fill this “void” by establishing a “consistent, professional approach to managing R&D outsourcing.”
The standards provide a competency framework for clinical outsourcing managers and were introduced to ensure those in this role have the abilities to do their job competently, Martin Robinson, co-founder and executive vice president, IAOCR, told Outsourcing-Pharma.com.
“This helps ensure that projects get off to a good start so that the trials have a better chance of running optimally, thus avoiding some of the significant impacts on timelines and budgets,” he explained.
Robinson said the industry's approach needs to shift from a focus on an individual’s tenure length to their competence – and the standards are “another crucial step in spreading a competence-based approach throughout the clinical research sector.”
“It’s not enough for industry leaders to take a tick-box approach and hope that people can perform their roles properly,” he said. “Considering what is at stake, it’s essential that leaders know their people can perform competently. This is about doing the right thing.”
PCMG has also developed a training course – Outsourcing Essentials – which is based on the competency and accredited by IAOCR.