Fraud Readiness: Is Your Company Fraud Fit or Ready to Flat Line?


Two of the most often asked questions by businesses looking to gage their fraud risk management efforts are “how do we know if we’re adequately prepared for investigations and audits,” and “are we doing the right things?” The reality is that your company shouldn’t be waiting for investigations or audits to occur to determine how fit you are to deal with major fraud, compliance or regulatory related events.
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Strategies for Creating Strong Clinical Trial Risk-Based Assessments


pictureWith the release of FDA’s guidance on risk-based monitoring, the EMA Reflection paper on risk based quality management in clinical trials, and TransCelerate’s position paper, many biopharmaceutical enterprises and CROs are trying to establish solid risk assessment techniques and infrastructures to enhance clinical trial data quality, strategy, and reduce monitoring costs. In addition, with the introduction of novel technologies and data integration capabilities, the world of biopharmaceutical business conduct is changing drastically.
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Six Strategies to an Effective Risk Assessment and Mitigation Program


So your Board of Directors and senior management just handed you the keys to a brand-new, shiny compliance program. It conforms to the seven elements of the OIG Guidance for implementing an effective compliance plan. You’ve been designated as the chief compliance officer with single-point accountability for managing the day-to-day operations of the compliance program (No. 1). You’ve approved written policies and procedures for implementing your compliance program (No. 2). You’ve developed and trained all relevant personnel on your compliance program (No. 3). You’ve implemented a hotline for employees to anonymously report putative compliance violations (No. 4). You’ve developed a comprehensive auditing and monitoring program, in partnership with Internal Audit and the company’s external auditors (No. 5). You’ve created a program to investigate and take corrective actions to remediate credible allegations (No. 6). And finally, you’ve demonstrated a track record of taking disciplinary action against transgressors (No. 7).
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