Bangalore based MetricStream, the market leader in enterprise-wide Governance, Risk and Compliance (GRC) solutions, has announced that it will manage the Corporate Integrity Agreement (CIA) compliance programme for one of the largest global pharmaceutical companies. As per customer request, MetricStream is unable to reveal name of the pharma company.
The solution will enable the company to integrate and streamline end-to-end CIA compliance processes while facilitating accountability and transparency at every step.
Under the terms of the five-year CIA agreement with the Office of Inspector General (OIG), the company is required to implement specific compliance measures with regard to risk reviews, policy implementation, training and education, disclosures, sales force monitoring, screening of ineligible persons, independent review, auditing and reporting. These measures will help the company to put controls in place to prevent off-label promotions, and ensure increased adherence to legally permissible sales and marketing practices.
Managing its conflict of interest program and complying with the CIA will also enable the pharmaceutical company to strengthen its commitment to ethical business conduct, enhance its ability to prevent fraud, and improve the standard of healthcare as per Medicare and Medicaid programme mandates.
MetricStream provides a comprehensive solution to simplify, streamline and unify the company’s compliance and ethics program and Corporate Integrity Agreement management initiatives across the enterprise. With the solution, the pharmaceutical giant will be able to seamlessly consolidate multiple processes including policy management, sales force risk monitoring, IRO audits, issue re-mediation, certifications and attestations, reporting and training on a single, centralized platform, stated the company press release.
The solution provides rich capabilities such as workflow automation, regulatory alerts, graphical dashboards and a centralized information library to efficiently address CIA requirements, and proactively prevent incidents of non-compliance. The solution also transcends organizational silos, enabling various entities across the enterprise to collaborate closely on CIA initiatives.
Using the MetricStream solution, the pharmaceutical company will be able to streamline and accelerate policy creation, management and review; efficiently map the policies to Federal healthcare and FDA requirements; and organize them in a centralized Web-based repository with easy access and search capabilities.
The solution will also enable the company to proactively monitor and detect sales force risks through Key Risk Indicators (KRIs), with automatic notifications indicating whenever thresholds are breached.
In addition, the solution will help streamline the complete audit life cycle to assess the effectiveness of the company’s compliance measures and controls. Issues that arise out of audit findings will be automatically routed through a systematic process of investigation, corrective action and resolution.
Powerful dashboards with drill down functionalities will help in tracking the status and results of various CIA compliance processes in real-time. In turn, flexible reporting capabilities will simplify the process of internal and external reporting by automatically generating reports such as the OIG-mandated Implementation and Annual reports.