According to Gerald DeWolfe, CEO of CRA Assessments, a fully assigned Clinical Research Associates (CRA) costs a company on average $350,000 (€259,000) a year to ensure the highest level of quality is assigned to their clinical trials.
However, current approaches to assessing a CRA, he told Outsourcing-Pharma.com, involve either a contract research organisation or pharma company sending out a more experienced CRA to watch the original one at work at a site.
“The issue with this is that it is subjective (the person overseeing the CRA and the site they go to have a significant impact on the evaluation), reactive (does not normally happen until well into the study), and expensive” with total travel and expenses racking up approximately $4,500 on top of the cost of the CRA, he said.
Work-Place Simulation Approach
As an alternative, DeWolfe’s firm has developed a work-place simulation platform, with web-based results, in which CRAs are evaluated on the same data.
“Instead of going to a site, we bring them to our site,” he told us, thus creating “a huge potential to use the data to evaluate trends from an individual CRA all the way to the entire CRA population.”
The pre-hire simulation takes an hour and a half to complete, whilst for current placed CRAs the simulation takes between four and six hours.
“There are no multiple choice questions or fill in the blanks…they are provided with documents just like they would see at a site and they are to make monitoring notes when they identify issues.”
He continued: “Once scored, we produce metrics that show number/percent identified by Critical, Major, and Minor by Module(pre-hire has 1 module; simulation for current employees has up to 3 modules). We also provide every issue the CRA was not able to identify and link them to the relevant CFR and ICH/GCP.”
Gaining Momentum
The platform was originally taken to CROs to give them a tool to show their innovation and commitment to quality to their clients, yet according to DeWolfe only one of the seven members of the Association of Contract Research Organisations (ACRO) took the firm up on its offer.
Though currently in discussion with a top five CRO, he said the approach has shifted to the pharma firms with one Big Pharma company potentially “going to mandate that it be used by any CRA that is working on their trials,” he said.