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Case Study 2: Bio Toxicity Testing of all new materials of a Drug Delivery Device

A small start-up drug delivery device company did not have the personnel who could structure the materials clearance testing to FDA and ISO standards. MDS had an ongoing contract with this customer. MDS was requested to create all necessary documentation, protocols, project plans, and manage all testing necessary to approve each of the materials to FDA and ISO standards. A separate project was initiated to accomplish these project tasks. Because MDS would do the project, the customer avoided the hiring cost, facility costs, and personnel costs, for a one time project. An initial meeting was held at the customer facility to sign all of the project initiation documents.

The project involved the creation of the customer's company Standard Operating Procedures (in the customers format), writing of all Protocols and Reports, selection and management of activities between laboratories, and the construction of all Customer Master File systems. The MDS project leader, working with the customer's project manager, and key contacts at the laboratories completed the project in seven months. The time needed to hire an internal staff member plus the new hire training time would have prolonged the completion date by two to three months. MDS initiated work on the project the day after the project launch. The entire project was done electronically. Work was split by organizations. The project proceeded smoothly with very few issues. A second meeting was held at the conclusion of the project to sign all project closure documents. Over the course of the seven months, fewer than 100 automobile miles and zero air travel was required to accomplish the project. Reduction of travel time not only reduced the project cost, it also eliminated commuter time and commuter energy consumption. This project shows the power of Digital Work in minimizing project cost and energy consumption. The project also demonstrates that sourcing Digital Work to a Digital Work company can reduce project time by reducing staffing time.