Applied Clinical Trials
CRO is the first to participate in IACOR’s accreditation pilot.
IAOCR, an independently recognized, competence-based accreditation, consultancy and accredited training organization within the clinical research sector, announced INC Research as the first to participant in its Clinical Operations Workforce Quality Accreditation pilot.
Previously, IAOCR’s accreditations extended to individuals in the clinical research sector, while training programs were available to individuals and biopharma and CROs, however, this is the first accreditation for a company as a whole. Martin Robinson PhD, Executive VP & IAOCR Ambassador, said in a statement, “The Workforce Quality Accreditation is not a training program, rather it assesses the processes and procedures the organization has in place to ensure their staff are competent and engaged. It focuses on the existing systems and whether internal staff have access to the correct training programs. Achieving the Workforce Quality Accreditation is a sign that the organization is following best practice, therefore reducing risk and errors, improving clinical timelines and improving staff retention.”
Richard Wood, INC Research’s director of global training, told Applied Clinical Trials that INC is confident about its current training. However, “This brings the outside accrediting body in place to see how we administer our programs to make sure our employees are trained and competent.” In addition, Wood says that a unique aspect of the IAOCR program is that it takes into account soft skills. “A project manager can be promoted into their role because of their experience, but can they handle conflict? Can they identify performance gaps in their direct reports and can they communicate those gaps effectively?”
The plan is for INC to complete its tasks and deliverables into the IAOCR system to achieve Bronze status this year and Silver next year. Initially IAOCR will be running the Bronze level pilots with four companies over the summer 2015 in order to finalize the accreditation processes before moving into the Silver and Gold level accreditations. The aim is for INC and other companies that have signed up to the pilot to move up through the levels, eventually to Silver and Gold. Robinson stated, “To gain accreditation organizations need to ensure their teams have access to relevant training programs and have robust processes in place to assess that their workforce is competent.” Wood said that as his team is going through INC’s programs and processes, President and COO Alistair Macdonald noted that INC is already achieving what the Academy is asking. “But we have to put together the documentation and prove we are doing these things. It is a lot of work to show to get the accreditation,” said Wood.
Robinson noted that the timeframe for an organization to undergo the Workforce Quality Accreditation depends on the size and geography of the organization, what level of accreditation they are going for e.g. Bronze, Silver or Gold and whether the systems in place are robust enough. As such, it should take on average approximately two to three months. Each accreditation level builds upon the previous one so that organizations who may be starting at the foundation stage can use a step-wise approach as they put in place the various components that are needed to achieve the requirements for each subsequent accreditation level. The Accreditation will be renewed each year and this process will be streamlined to ensure the existing processes are still providing the required competence standards.
Wood discussed the increased availability of training, education and formal degreed programs for clinical research professionals. “We have worked with universities in the area to develop programming or have those pursuing a clinical research degree come to work with us as student fellows. We have also brought IAOCR trainers into our company to train our clinical and project manager trainers to be accredited to train incoming CRAs and PMs using our internally developed training materials,” said Wood. “All of that has value…degrees and education. But we have to figure out how they are competent for the job, which is what accreditation will do.”
IAOCR believes The Workforce Quality Accreditation will help to reduce vendor oversight costs related to compliance checks and new and changing project staff while bolstering confidence that training and competence programs have been independently verified. The accreditation mark will provide reassurance that the achieving organization has better quality staff, which in turn improves trial efficiency and lowers costs.