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.
