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Compliance
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Function Dynamics
Compliance demands have escalated steadily in recent years, driven by high visibility investigations of clinical and commercial activity tainted by conflicts of interest. The result has been a dramatic increase in legal requirements, compliance monitoring, enforcement action and unfavorable media scrutiny. These enforcement trends, and the resulting demands on compliance programs clearly indicate that from now on the compliance function in companies will be examined to determine its actual effectiveness. Enforcement activity and new laws, both state and federal, make compliance and transparency critical areas of focus. Yet despite the years of experience most companies have had addressing these challenges, many continue to struggle toward timely, effective implementation.
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Business Challenges
In this environment of greater regulation and demands for transparency, Compliance is facing regulators intent on examining programs for effectiveness - not simply for maintenance. Designating a corporate officer and establishing policies and procedures alone are not enough. Organizations intent on results, and on demonstrating good faith efforts as a fallback, must do more. Building compliance components into every manager’s accountabilities and actively auditing and remediating gaps have become table stakes. Real effectiveness requires proactive steps to facilitate change in processes and stakeholder relationships that ensure consistency with evolving regulatory and legal requirements. Compliance needs to become more strategic and consultative, selectively applying the right tools to help the organization embed quality and transparency, and extract more value from core processes. More time needs to be spent helping line management define new approaches, challenging current process assumptions, and introducing more structure and accountability to ensure consistency with evolving regulatory and legal requirements.
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Our Depth of Knowledge
Success in today’s marketplace requires both great strategy and an integrated approach to the design and management of quality and compliance systems to make that strategy come alive. Over the last 20 years we’ve helped clients in a wide variety of industries address both the "what" of strategy and the "how" of implementation. Our services are intended to help clients design or redesign and implement systems that enable strategically important performance in the organization. And we help Compliance leaders build departments capable of delivering on their value proposition.
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