The Business Analytics Challenge

Companies in the life science and FDA regulated industry often treat each compliance requirement as a separate management program. This could be a clinical trial reporting operation, manufacturing lot tracking, or one of many other requirements. Programs such as these tend to thrive in the industry. Each program develops their own approach to gathering data to report to regulatory authorities, however, this may increase the risk for additional compliance costs and potential mistakes. Life science firms can now build an approach to standardize compliance by building it into their business processes.

The Business Analytics Solution
Self-service BI apps built to integrate with the ERP system offers high performance to address and demonstrate capabilities related to compliance in the life science industry. Implementing a compliance structure for collection, organization and analyzation of large volumes of data and reporting can be done in a suitable, homogenized manner. FDA regulated companies have the ability to:

  • Improve regulatory oversight for a streamlined product approval process
  • Optimize pharmacovigilance with improved data analysis
  • Leverage an associative data model to intuitively analyze adverse reactions
  • Monitor critical KPIs such as serious flags, proportional reporting ratios, and timeline for report to FDA (including the number of late reports and reasons why)
  • Track and audit standing across multiple compliance programs to avoid oversights and improve overall compliance effectiveness
  • Use trending and what-if analysis to gain insight into compliance efforts and make continuous improvements over time
  • Streamline legal reporting and project management
  • Benchmark drug safety measures

Conclusion
With an evolving set of regulations affecting today’s life science companies, there is more pressure to track performance and ensure operations and production are closely tracked to ensure quality and avoid a potential audit from the FDA. With new analytic capabilities, companies can more rapidly analyze and report on information from many different sources. Business analytics offers life science firms with accurate, quality data, and the ability to provide oversight over compliance mandates that would be otherwise be difficult to discover in a timely manner.

Choosing an Analytics Consultant
There are few industries as complex and data intensive as manufacturing organizations. The Copley Consulting Group knows there are several factors to determine the right fit for your organization. When working to implement your analytics solution, Copley can provide the technology and support needed for your specific industry and business. To discuss an analytics solution for your organization, complete our contact form, call us at 855-884-5305, or email us at info@copleycg.com. 

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