P&G Prep

Problem/Issue Statement

What is the problem?

Procter & Gamble’s main issue is the length of time it takes to bring a prescription drug to the market. The process can take several months and up to several years to complete.  On a daily average, this can cause the sponsor to lose up to 1 million dollars in sales, due to the delay of market entry. The paper-based method, which is mainly, applied through the clinical phase trial is a huge factor that prolongs the process. Changing a legacy system for any business is a risk and P&G must decide if the alternative options for changing the system are worth the risk.

What is the distinction between the problems and the symptoms?

The problem consists of the paper-based methods used for management of the trial. There are three lengthy phases, the trial preparation, data collection and verification and data management and review. Each phase consisted of lengthy, tedious procedures with some repetitive tasks. Although, each step is necessary for the safety and validity of the trial, the paper-based method adds steps that prolong the process and creates more room for error. This in turn, causes P&G symptoms, which are the incurring costs and losing valuable time in entering the market. In their current clinical trial procedures, phase 1 averages an out-of-pocket expense of $15 million, phase II averages $24 million, and phase III can cost an average of $86 million.

What is the scope of the problem?

The scope of the problem is the current method in place of documenting and organizing information through the paper-based process. Processing inefficiencies causes the delay of time to data lock, which could set the market entry back by 6 months or up to a year.

Situation Assessment

What is the context of the problem?

The context of the problem is changing the company’s legacy system and implementing changes that will enhance the utilization and efficiency of each phase.

What are the decision criteria?

-The cost factor of implementing changes

-Will changing the legacy system reduce market entry timeline?

-Are the changes feasible for every phase across the board?

List of Plausible Alternative Courses of Action

What are the alternative courses of action?

Proctor & Gamble has three alternatives for improving trial performance. First, is improving the paper-based process by hiring more staff and using express mail shipments in order to expedite the process. Second option was the use of digital imaging, this would allow data to be automatically stored by the system. The third option was the web-enabled EDC, this process had information entered directly into a data management system directly from the investigative sites.

How does each address the key problem?

The first option, improving the paper-based process does not clearly address the key problem. It attempts to reduce some time but at the cost of hiring more staff and resources. There would be no significant improvement.

The second option, digital imaging delivered some improvement but in the long term requires extensive memory and capacity in the system to maintain this data, which in turn will be costly.

The third option, web-enabled EDC allowed investigative sites to enter information directly into the data management system. Therefore, reducing the potential errors that occur during the initial stages and omitting a double entry step. The information entered would be immediately available to sponsors, which aid in monitoring the trial. Overall, it reduces the length of processing.

Evaluation of Alternatives

Through what theoretical concepts should one evaluate the alternatives?

Theoretical concepts that should be considered when evaluating alternatives are the cost benefit analysis and the cost effectiveness analysis. The cost benefit analysis will help determine the net value of implementing a new process. It will find and quantify all the positive and negative factors. It will help you determine the consequences and whether the benefits outweigh the costs. Cost-effectiveness analysis helps identify ways to redirect resources to achieve more. It demonstrates the advantage of allocating resources from ineffective to effective interventions and also the advantage of allocating resources from less to more cost-effective interventions.

How does the evaluation relate to the decision criteria developed?

The evaluation relates to the criteria by identifying and directly relating the financial implications of different alternatives. If Proctor & Gamble can identify the short-term cost and compare it to the long-term benefits, it can evaluate a decision based on quantifiable measures.

How imaginative can/should the evaluation be?

Imaginative evaluation should not factor in because Proctor & Gamble can evaluate their decision based on real cost analysis.

Recommendation

What is a quality recommendation?

A quality recommendation would be to choose the option of implementing the Web Enabled EDC. The initial cost of implementing this process would be costly but the long-term benefits outweigh the cost. P&G will have the potential of drastically decreasing its data lock time down from weeks to days. The use of this system helped detect difficulties in trial execution early on and therefore facilitates and reduces the process time. Most importantly, by reducing the length of time in the trial phase, it is able to enter the market more rapidly and therefore, increasing sales revenue. It’s also important to mention that by entering the market early on, P&G is able have more time in the market with its patent and not have to compete with generic competitors so fast.

What is a logical recommendation?

A logical recommendation would be to implement the Web Enabled EDC. The paper-based method for clinical trials allowed duplicate entries and much room for errors. The cost associated with this method was not only monetary but also timely. Although, other large pharmaceuticals companies were still using the paper-based method, it would most likely be a matter of time before they would adopt this method. It’s very logical and the feedback from site coordinators and focus groups were pretty common issues that could be resolved in a matter of time.

Presentation

If I were presenting, how would I sum up the case?

I would sum up the case by identifying the need to implement a change in our process and how reducing the length of time would create a great impact on revenue.

What key visual aids would I present?

I would use ppt to outline and identify where changes can be made to create efficiency and reduce processing time. Each alternative option would have a chart to show the financial impact of every phase.

How would I sell the recommendation?

I would sell the recommendation by highlighting the competitive advantage P&G would have by pioneering this new process.

What other delivery considerations should I keep in mind?

I would also implement solutions for hiccups that might occur when implementing this new process.