Bangalore-based MetricStream, a market leader in the enterprise-wide Governance, Risk and Compliance (GRC) and Quality Management solutions, has been selected by Kendle International Inc, a leading global clinical research organization, to carry out its compliance and quality management, automating and streamlining its auditing and corrective action/ preventive action (CAPA) processes.
As one of the world's largest global providers of phase I-IV clinical development services, Kendle is focused on innovative solutions for its clients that reduce cycle times and accelerate the delivery of life-enhancing medicines to market. Tools such as the MetricStream platform will enhance Kendle's worldwide, class-leading operational practices.
According to Shankar Bhaskaran, senior director & head, International Business Operations, MetricStream. "Kendle presents a promising opportunity. Our platform will play a critical role in further enhancing the CRO's quality management processes, while at the same time, driving down the cost of compliance."
The solutions from MetricStream's will allow Kendle to automate the tracking and management of compliance and quality events to ensure that operational activities are continuously measured, monitored and improved upon. It will also deploy its advanced, risk-based audit management module to automate and streamline all aspects and functions of Kendle's Clinical Quality Assurance audit program, from the management of periodic and ad-hoc audit schedules through the tracking of audit observations, findings, recommendations and the resulting audit responses.
It will assist Kendle's Clinical Quality Assurance auditors in planning and executing audits even more efficiently by providing a powerful, integrated tracking system and workflow engine, automating all steps in the audit lifecycle, including audit scheduling, audit preparation, audit execution, audit report approval, audit report issuance, audit response and any associated corrective action tracking.
In tandem with the MetricStream audit management module, MetricStream's CAPA management module will be used to manage the implementation of corrective action/preventive action plans, providing seamless traceability for all related issues and incidents. MetricStream CAPA software will enable Kendle to implement a robust architecture for logging and managing quality issues originating from any source, while its automated workflow engine routes records through all investigation steps, including root cause analysis, CAPA planning, CAPA verification and effectiveness steps.
By providing an enterprise-wide system that can be accessed by all 3,600 Kendle associates across the globe, MetricStream's integrated, web-based solution further enhances Kendle's best-in-class service offerings for the biopharmaceutical industry.
Enhancing Kendle's already robust quality management system with the MetricStream platform will continue to improve cycle times for our clients, as well as reducing regulatory liabilities, risks, and costs for Kendle and our clients, said Christopher Bergen, executive vice president & chief administrative officer, Kendle.