Biotech Firm Complies with New Aggregate Spend Regulations, Gains Operational Efficiencies

download case studyConsidered the founder of the biotechnology industry, this leading biotech company has developed and marketed medicines for serious or life-threatening conditions for more than 30 years.

The Challenge: Legislation regarding aggregate spend on communications with healthcare professionals and organizations involved in healthcare management has recently been enacted. In accordance with these regulations, the company needed a solution to address current and future monitoring, tracking, and reporting requirements. However, spend data was housed in multiple data sources across the organization in varying formats and with questionable data quality. Aligning this data to enable reporting was complex and manually-intensive, with no formal mechanism for accurately monitoring and reporting on the Aggregate Spend. While the company struggled to meet these requirements, they realized that continued regulatory change was likely adding more complexity to the issue and putting the organization at risk of failing to be in compliance.

The Solution: Supported by Saama’s dedicated Life Sciences practice and its arsenal of data management tools and BI methodologies, the Saama team designed a comprehensive compliance solution to address the aggregate spend reporting requirements in a systematic and efficient manner, while satisfying the reporting needs of sales and marketing as well. Spend data was extracted from back-end sources, cleansed and then run through a business rules engine that applied both federal and state compliance regulations. Final data was stored in a data mart that ultimately generated the reports necessary for both compliance and business operations. Furthermore, based on previous experience, Saama created front-end applications to enable users to make data corrections, amend business rules and manage aggregate spend alert cases without accessing source data or making system changes.

The Benefits: Since implementation, the aggregate spend application has helped the organization:

  • Meet current and future state/federal reporting requirements
  • Increase operational efficiencies though online compliance management
  • Improve data quality to enable more strategic spend decisions
  • Identify inappropriate spending and remove the risk of fines due to non-compliance
  • Reduce time and cost by automating report generation for compliance, sales and marketing
  • Improve data quality to enable more strategic spend decisions
  • Support ad-hoc internal and external reporting

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