Carl McCauley, MetricStream sales VP told Outsourcing-Pharma that the solution addresses PRA’s specific requirement to maintain quality and compliance management “by providing solutions to measure, monitor and improve quality, as well as manage regulatory obligations” in the global clinical research environment.
Under this premise, McCauley said the use of the system will be significant as it will “help PRA move ahead from an environment wherein we were using point solutions, in-house built tools and manual processes to an automated solution.”
“PRA will now be able to surmount the growing pressure on account of the various industry regulations in the clinical research industry,” he added.
Integrated CAPA Management module
By putting the key features of MetricStream’s Audit Management and CAPA module to good use, PRA will have access to built-in issue tracking, remediation workflows, email alerts, and reporting of best practices to enable auditing for ongoing compliance.
“The solution influences how we generate better quality data by ensuring that PRA International will comply with all the regulations in the clinical research industry space, managing the complete audit management lifecycle, along with corrective and preventive action,” said McCauley,who believes the solutions ability to generate industry specific reports and dashboards will reinforce this.
MetricStream also claim its technology will be easier for investigators to use at trial sites compared to other systems which are available, as it provides an offline-function, and promises an ‘easy-to-use’ interface.
This McCauley continued, will “minimise the learning curve and ensure quick adoption, as the system shows information to a user based on her role."
As the cycle of drug discovery and development can stretch over long periods of time, this can inevitably have an impact on the cost of running trials, but MetricStream claim its compliance, audit and quality management solution will streamline the entire process by integrating it within one solution. They remain adamant this will “help reduce costs and increase quality.”
Prior to PRA’s decision to make use of MetricStream’s web-based software solution, trials contractor Kendle International, adopted the management platform to help control its global compliance and quality assurance operations.