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MetricStream’s Audit Management and CAPA Management Solutions enhance INC Research’s compliance with quality assurance standards, regulations and internal policies
November 06, 2012 | Palo Alto, California: INC Research, LLC, a therapeutically focused clinical research organization (CRO) with a Trusted Process® for delivering reliable results has selected MetricStream to streamline Audit Management and Corrective Action/Preventive Action (CAPA) Management.
INC Research is a trusted name in clinical research, providing a complete range of customized Phase I-IV programs for pharmaceutical and biotechnology companies worldwide. A powerful force in the clinical development industry, the Company ranks among the top-tier CROs based on size, scale, and geographic depth. Today, INC Research employs nearly 5,000 employees across six continents, and is known for its expertise, quality, and performance.
“At INC Research, we hold ourselves to the highest standards of quality,” says Wayne Whittingham, Vice President, Corporate Quality. “MetricStream’s solutions will be an important part of sustaining those standards of quality as we grow and expand. We selected MetricStream based on the company’s rich domain knowledge of the Life Sciences industry which enabled them to support a large, growing organization such as ours.”
MetricStream provides a comprehensive solution for CROs to manage all critical processes such as multiple ongoing audits, quality management initiatives, compliance evaluations, facility inspections, and corrective actions which, in turn, enhance compliance with regulations and guidelines from the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Office of Research Integrity (ORI), International Conference on Harmonization (ICH), and other regulatory agencies. The solution enables an approach based on risk intelligence to effectively manage and mitigate risks for better decision making and optimal process outcomes.
INC Research will use MetricStream Audit Management Solution to efficiently consolidate and manage the complete range of quality and compliance-related audit processes, data, activities, and entities on a single GRC platform. INC Research anticipates MetricStream will help streamline and integrate end-to-end audit initiatives across multiple phases of clinical research, thus eliminating duplicative audit activities, thereby improving efficiency, and reducing costs.
INC Research will also be using MetricStream CAPA Management Solution to efficiently manage corrective and preventive actions in compliance with guidelines from ICH. Issues or complaints that arise from audits, quality management processes, documentation non-compliance, and other areas of non-conformance would immediately be routed by the MetricStream solution through a systematic, closed-loop process of investigation and resolution.
The MetricStream solution will facilitate the CAPA process through automation, teamwork, and enhanced transparency into the status of remediation activities through dashboards and reports. This in turn will help managers ensure that proper actions have been taken to eliminate the root cause of an issue.
“In the world of clinical research, the smallest error in judgment can lead to patient misdiagnosis, delays in the release of drugs, and high retesting costs. Therefore, quality is of utmost importance, as is compliance with regulatory guidelines and clinical trial protocols,” says Gaurav Kapoor, Chief Operating Officer at MetricStream. “The MetricStream solution is equipped with a rich array of capabilities such as built-in status tracking, automated alerts, remediation action workflows, and integrated best practices that enable CROs to conduct consistent and thorough audits to enhance their credibility with pharmaceutical companies, doctors, and patients.”
MetricStream is a market leader in Enterprise-wide Governance, Risk, Compliance (GRC) and Quality Management Solutions for global corporations. MetricStream solutions are used by leading corporations such as UBS, P&G, Constellation Energy, Pfizer, Philips, BAE Systems, Twitter, SanDisk, Cummins and Sonic Automotive in diverse industries such as Financial Services, Healthcare, Life Sciences, Energy and Utilities, Food, Retail, CPG, Government, Hi-tech and Manufacturing to manage their risk management, quality processes, regulatory and industry-mandated compliance and corporate governance initiatives, as well as several million compliance professionals worldwide via the www.ComplianceOnline.com portal. MetricStream is headquartered in Palo Alto, California and can be reached at www.metricstream.com.