Proctor and Gamble

Problem/Issue Statement:

Proctor & Gamble is experiencing a longer wait time versus its competitors when trying to reduce the time is takes for clinical trials in its pharmaceutical division to be completed and bring new products to the market. The current process involves using data collection that is paper based where the first portion of information is collected on site by the coordinator, then this information is verified by the clinical research associate, and then this is manually inputted into P&G’s database by the clinical data manager.

The problem is found in the data collection process that is lengthy and involves multiple parties that are duplicating work. This involves the aforementioned parties collecting the data on site, then passing the same information to be verified by the clinical research associate before it is entered in to the P&G database. These steps are the cause of increasing lag times in sending/receiving the data by paper versus utilizing the internet to take advantage of Electronic Data Capture (EDC).

Situation Assessment:

The situation with P&G is their need to decrease the time between the trail and bringing the drug to shelves. The process that is in place currently involves a great deal of paper being transferred by hand which is causing for the trial to last longer and decreasing profits. The goal of the consultants is to assess the alternatives to find the most effective and efficient way to streamline the process and increase profits for P&G.

List of Plausible Alternative Courses of Action:

Three alternatives were presented of consideration involving P&G current process. The alternatives are improving the paper-based process, Web-enabled EDC, or Digital Imaging.

Improving the paper-based process would involve using express mail shipments on a daily basis as well as hiring additional staffing to speed up the verification process.

Web-enabled EDC is the toughest out of the three options to implement. The reason behind that statement is due to the amount of training involved to bring all the employees up to speed on how the system works and make sure that the level of training provides enough knowledge to access the program. In addition to the training, the facilities that P&G operates these trials from will need to have their systems updated and provide system access with various degrees of access to its employees.

Digital Imaging is the ability to take the completed paper documents and transfer the information via fax to receive the information in a digital format and save to the system. The limitation with this option is the level of training that needs to be administered to the employees.

Logical Recommendation:

The logical recommendation would be the web-enabled EDC. This new process will decrease the amount of time it takes for the information to be inputted in to the system. With this new system, patient data is keyed into the system allowing for the transmission of the data to be instantly available. However, for the convenience of the system would require P&G to spend more in initial cost and training. But in the long run, this process would show greater efficiency and ultimately pay for itself once new products are able to make its way to market quicker.

Presentation:

The focus of the presentation should be on the ineffectiveness of the current process. This should be illustrated by using flow charts and showing where the lag occurs. Once this has been identified my team and I would then propose the solution we would choose. We wouldn’t necessarily discuss the alternative as Digital Imaging does not stand up to Web-enabled EDC. With the solution proposal we would discuss the ease of use and how the employees will adapt seamlessly with the new process with the training that is provided. Here would be a good time for the team to talk about how the information is secured to address any uncertainties with the system. Finally we would conclude the presentation with the cost savings over time when using EDC and how profits increase per drug by the decreased time in processing information during the trial and getting the drug on the shelves.

Reflection:

After hearing the consultants present their case to P&G, I found that we both agree that EDC is the best option overall. The group provided an in-depth overview of the process demonstrating their understanding of P&G and their pharmaceutical division. The group did explain each alternative spending the majority of time touching on EDC and its benefits. Another good point I noticed with the group is the explanation on savings with each alternative which illustrates from a dollar perspective which would be a contender for the new process. In the end I feel the consultants provided a quality presentation to propose a solution to P&G.