Efficiently Managing Globally Dispersed Clinical Trial Documentation

I had a chance to connect with Emerson’s Michalle Adkins, a Senior Consultant on the Global Life Sciences Industry Solutions team. She shared a story about a leading company, which conducts clinical trials for pharmaceutical and biotech manufacturers.

Their challenge in conducting these clinical trials is the requirement to manage a huge number of documents from several locations around the world. Michalle and members of the Life Sciences Industry Consulting Team along with Emerson local business partner, RE Mason, worked with the clinical trial management provider using the business problem understanding type of methodology. In an earlier post, Using Operational Excellence Techniques to Understand and Solve Business Problems, we described this methodology in detail. It follows the DMAIC (Define, Measure, Analyze, Improve, Control) improvement process. The project team helped the provider to map out their current process, define the requirements, evaluate the potential benefits/ROI, and develop a request for quote instructions document.

The project began with a business process study phase. The solution included the Syncade operations management software suite as the platform for managing these globally dispersed documents. The provider’s project team saw the opportunity after the project had been awarded to the Emerson Life Sciences team, that they could use the same solution to manage their policies and procedures document management.

The provider also saw the opportunity to manage their personnel training through the linkage of the Training and Development module and Document Control & Archiving module in Syncade. In the process of managing the documents surrounding clinical trials, it’s a necessity to make sure that the personnel involved in this process have the required training and that these training records can be accessed upon demand. With thousands of global employees, this can be challenging and labor intensive.

Michalle noted that the project team is currently in the midst of executing a pilot for this project. Once the pilot proves the sought after improvements, they will be ready to deploy the full project scope. The annual benefits are estimated to be around $370,000 (USD) for only the clinical trials management portion. The quantified benefits for the policies and procedures and training and development portions were not included in the original Operational Excellence (OE) analysis phase since they were added to the original scope, but these areas will be tracked when the full project scope is executed.

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