Rapid Process & Procedure Harmonization

SITUATION

Clinical, Medical, and Regulatory functions for eight operating companies of the world’s largest medical device company aspired to harmonized processes and procedures within a 6-month period.  The company had largely been built by acquisition and had to complete the project on time due to compliance-related issues.

SOLUTION

  • Halloran assessed 450 procedures for applicability to these functions and narrowed to 250 in scope. 
  • A harmonization plan consisting of 250 legacy procedures and associated forms and templates was developed, reviewed, and finalized in less than 4 weeks. 
  • Eight workstreams led by Halloran and consisting of 100+ leads, writers, SMEs, and Steering Committee members harmonized processes to a final set of 71 procedures and 154 associated forms, templates, and attachments in 4 months.
  • The project was delivered on time and under budget.

VALUE

Halloran was able to complete this project within the specified timeframe, which allowed the company to meet their internal company and external compliance timelines.   The company subsequently asked Halloran to assist in harmonizing job descriptions for the same functions.