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Standardization of R&D Outsourcing Becomes a Clinical Research Reality

Bold steps have been announced today about the standardization in the approach to R&D Outsourcing. IAOCR and the Pharmaceutical Contract Management Group (PCMG), have jointly developed new standards for the management of pharmaceutical R&D Outsourcing and the development of professionals working in this area.
These standards include a core competency framework for Clinical Outsourcing Managers and the accreditation of PCMG’s flagship training course, Outsourcing Essentials. The framework for Clinical Outsourcing Managers describes the core competencies that are necessary for this role. The accredited outsourcing course further supports this framework by ensuring that the training is focused on the knowledge, skills and behaviors relevant for the outsourcing role.
IAOCR, the accrediting organization for the international clinical research industry, and PCMG, the leading clinical outsourcing community, share a common goal of improving standards of best practice in the clinical research sector.
“‘Clinical Outsourcing’ covers an increasing range of responsibilities required to achieve clinical trial success in the highly regulated, demanding and competitive Phase I-IV environment. There is no standard career path to this vital role, so the steps that PCMG and IAOCR are taking are really filling this void. Our aim is to foster a consistent, professional approach to managing R&D Outsourcing; working on these initiatives with IAOCR is an important step in clarifying and standardizing the competency requirements of the clinical research industry,” explained Antje Hindahl PCMG Director. “Working with IAOCR we were able to achieve an important benchmark for the industry which will grow in significance in the coming years, as the industry evolves and the importance of outsourcing excellence increases.”
“We’re delighted to be able to support PCMG in raising standards in clinical research outsourcing,” Jacqueline Johnson North, CEO and co-founder, IAOCR stated. “Over the last seven years, IAOCR has focused on ensuring that people and organizations conducting clinical trials are competent. With PCMG we’re breaking new ground by ensuring that professionals responsible for outsourcing clinical trials both understand the importance of outsourcing to competent organizations as well as being competent in their own roles. The industry is identifying that competence verification is essential to the effectiveness of clinical trials and a robust approach is necessary.”
The accredited Outsourcing Essentials Training Course takes the form of a two-day program which enables participants to lead the outsourcing processes from vendor selection to contract close-out. The IAOCR Three Star Course Accreditation symbolizes the high-quality course materials and confirms that the course covers and supports the relevant competence areas. The course will be run for the first time under its accredited status in London on the 10th and 11th of April, 2018.