The Life Sciences industry tends to undergo fundamental changes on a frequent basis. This is due to changes in customer needs, regulatory expectations, new scientific discoveries and new research and manufacturing technologies. All of these changes must be managed in a sound business manner, recognizing scientific reality and the need for regulatory compliance.

Leading Life Sciences organizations manage these risk elements in a real-time, pragmatic and best-in-class fashion.  Such organizations also fully understand how one risk (or set of risks) affects another.

Business & Decision's Approach to Enterprise Risk Management

The Business & Decision approach to Enterprise Risk Management is unique and highly collaborative, leveraging twenty years of experience in the Life Sciences industry as well as our leading approach to Enterprise Risk Management in industries such as financial services, banking and insurance.  It is a results-oriented approach and delivers comprehensive documentation that can be used for business case modeling, goal setting and risk mitigation project management.  It is also flexible and reusable so that client teams are able to manage on-going risks and future risk-management projects.

We offer both an Enterprise Risk Assessment (ERA) and Enterprise Risk Management (ERM) program approach where the "Enterprise" is scaled to a specific set of business functions. These business functions may include quality, manufacturing, distribution, human resources, financial, information technology, legal, compliance or any functional area. Our approach will identify, assess and begin to mitigate risks, prioritizing activities to provide best return on investment and balancing this against the strategic objective of the function and the enterprise.

At a tactical level, Business & Decision are also able to assist clients to develop Risk Assessment, Risk Analysis and Risk Evaluation models, using a variety of relative, qualitative and quantitative criteria, using appropriate tools and methods and leveraging standards and guidance such as ISO 14971 and ICH Q9.

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