P&G Case

What is the Problem?
The problem that Proctor and Gamble faces is the amount of time it takes for them to have a prescription drug go through the clinical trials because of the elapsed time between the collection of the last piece of data on the final patient in the study and the locking of the database, which is known as Data Lock. The more time that a prescription drug goes through a clinical trial period because of long data lock times, the company loses out on potential sales and also loses on time that a patent protects their drug from hitting the open market to have it only be manufactured by a generic drug company. There is a value to the amount of time that a drug spends in a clinical trial, and P&G is looking to capture the most amount of value as their prescription drug business was a major driver of the significant growth in P&G’s Health Care Segment.

What is the Distinction between the problems and the symptoms?

The problem that P&G is facing is the amount of time that is needed during a clinical trial for the patient’s information to hit the Data Lock stage. The symptoms of this problem are the need for double-entry of data under the paper-based system in order to verify consistency, the need of a third person to resolve any discrepancies, the lag time it would take a CRA to resolve any violation queries, and the bulkiness of binders used for the hundreds of patients used in a clinical trial.

What is the Scope of the Problem?

The scope of the problem for P&G is for them to find out what is causing extended lag times which prevents information from reaching the Data Lock stage quicker. While it is important to be thorough in completion of the data being entered, Ray D’Alonzo is looking for a way to shorten this time which will help expedite the Clinical Trial period while also increasing accuracy of the data.

What is the context of the Problem?

The context of the problem that D’Alonzo and his staff face is whether to overhaul the current paper-based system in order to implement a new and assumed to be quicker method of data entry. D’Alonzo sees the paper-based entry system as cumbersome and often there are a lot of discrepancies which causes a lag time. Every extra day that a prescription drug spends in clinical trial, the company is losing out on lost sales. D’Alonzo has options to overhaul the system, but those methods involve new, untested methods.

What are the decision criteria?

The decision criteria for choosing a method for data entry should include what will create the most value for the organization. The current method that they utilize is slow, but it works for them. The company is generating money with its current system. Is it worth upsetting the apple cart in order to potentially drive more value with a new technology? The value that can be created is based off of decreased data lock times which will help expedite the clinical trial periods.

What are the alternative courses of action?

1. P&G can continue with improvements to their paper based methods but increase the size of their staff and also use express shipping methods onsite.

2. P&G can utilize a digital imagining system that would allow for digital transmission of data back to P&G from the medical centers.

 3. P&G can implement a Web-enabled Electronic Data Capture (EDC) system to input data.

How does each of these address the key problem?

1. With increasing the size of the staff in order to take care of the data entry using the paper based system it will help cut down on times and speed up the process. The staff is familiar with this system so there will be no need to re-train the entire staff and lose out on any productivity. By using express mail, they would also be able to quicken the delivery process which will allow for more paperwork to be completed by the increased staff.

2. Digital Imagining was a way to fax over information which cut down on delivery times of data from a medical site to the company in order to input the data. This system also allowed for familiarity from the staff so again there would be no need to retrain staff.

3. Web-Enabled EDC addressed the key problems of lag time as data was able to be inputted directly from the investigative site. It was also able to identify any problems in the data so that they can be corrected immediately instead of reconciled during the second entry stage using the paper-based system. No double-entry was required and the information would be made available immediately to all parties involved.  

Through what theoretical concepts should one’s evaluation of the alternatives?
The theoretical concept P&G must use in order to evaluate the alternatives is the value lost in their product in the time it takes for the prescription drug to go through the clinical trial period due to the increased times it takes to get to the Data Lock Stage.

How does the evaluation relate to the decision criteria developed?
The evaluation relates directly to the decision criteria developed as P&G is looking for ways to capture the value of any potential lost sales. It is a very expensive venture to develop and market prescription drugs. By having the drug tied up due to antiquated methods, the company is only losing out on lost sales because the drug is not available to consumers.

How imaginative should the evaluation be?

The evaluation should be very imaginative as P&G should look to create innovation and also invest in a method that is a viable long-term option. At the time of P&G’s decision it was a very interesting time in the world of computers and the internet. The internet was supposed to be the future and it was still working out some of its growing pains. A few years before this decision, a dot-com bubble burst and a lot of companies were left for dead. P&G needed to be careful of making this decision but it realized that the paper method was becoming antiquated and there had to be a more innovative way.

What is a quality recommendation?

A quality recommendation for P&G would be for them to invest into the Web-Enabled EDC as the internet appeared to be the future and P&G would be an innovative company in going in this direction. The problem that P&G was facing was the amount of time it took for the information to hit the data lock stage. This method of data input directly related to this issue. It was shown that Web-enabled EDC cut down on the time and also the errors in the data input.

What is a logical recommendation?
A Logical recommendation for P&G would be to invest in more human capital in the paper-based data entry method. The system that they had in place was working for them. Their prescription drug business was a sales driver and they were able to use the paper-based method all the while. The problem with the paper-based method was the amount of time it took to get to the data lock stage. By investing in more people to come in to help the problem and also looking into express shipping, they would be able to get more done at a quicker rate using the current system. It would require no re-training as the system would not be overhauled and everyone involved in the process would be familiar with the program.

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

I would sum up the case by stating that the data lock times are causing tremendous delays in prescription drugs from going through clinical trials. The time is from the paper entry method which has flaws in it that include the need for data to be entered twice and the need to go through the information again to correct any mistakes. Also, there is a cumbersome amount of binders and paper work for any given trial. The technology exists that we can be able to expedite this process, and by doing so we can get the prescription drugs out of the clinical trial periods and into the market place. By doing so, we can capture the value of lost sales from days that it is not on the market and also buy more time with our patent protection.

What key visual aids would I present?

I would use charts and diagrams that illustrate the amount of time used for each alternative. I would also model a way to show the value of lost sales because of the time delays we are facing. It is important to show a business what they are missing out on. The current method they are using is a time-intensive method, and by looking at key alternatives we can expedite the process and gain sales on those lost days.

How would I “sell” the recommendation?

I would inform the P&G staff that the internet is a world of opportunity. They have the ability to venture into something that is innovative and also proven that it has the potential to work. They would be one of the first organizations to get into this and it would have substantial impacts on their future. They could have the ability to outperform some of their major competitors and become a big player I the market place.

What other delivery considerations should I keep in mind?

It is important to inform the company of all the risks associated with any venture. While the positives are the money, a time line would need to be created in order for them to understand there might be interruptions in productivity. At the beginning of implementing this technology, it may not move as quickly as previous methods, but over time it can make a substantial impact. Also, any security risks would need to be dispelled in order ease the minds of those concerned with information being exposed. Other than cost of software, information would need to be made for all costs that could be potentially involved. Informing them that the availability of computer and internet access is not there yet as the infrastructure is slowing being made. In order to make a “wowing” presentation, all aspects need to be considered as it shows understanding of what is involved and how it can positively impact the business. It is my belief that Web-enabled EDC is the way that P&G should go into as the innovation is there and also they have shown its success in trial runs with the program.