P&G Case Prep/Reflection

Problem/Issue Statement

• Procter & Gamble’s trial process is very tedious and extensive and results in delayed data locks which could ultimately push back the market entry of a drug.

• The problem that Procter & Gamble faces is the need to improve the current process. The symptoms associated with P&G’s problem are duplication of efforts which could total up to 25 labor hours during the course of a trial. In addition, there is the possibility of human error related to data entry which could result in further delays and errors.  P&G’s current process also involves frequent and costly sponsor support. 

• The scope of the problem involves the need to improve the overall trial process at Procter & Gamble.  It is not solely a data entry issue but must also review the entire process to ensure the flow and data gaps and concerns are addressed as appropriate.

Situation Assessment

• While the most attractive alternative for P&G is the implementation of EDC, P&G must also consider the effect on the overall process.  As mentioned before, the issue is not solely a data entry issue which causes delay in the trial process.  While this lag or delay may be solved with the EDC, it will be necessary to evaluate the entire process.

List of Plausible Alternative Courses of Action

• The three alternatives that P&G has analyzed as a potential solution to the problem it faces are:
• Improving the paper based process
• Digital imaging
• Web enabled electronic data capture (EDC)

Recommendation

After reading the case, I would recommend that P&G implement the EDC to improve their trial process.  By implementing EDC, the data would be entered to the data management system directly by the investigative sites.  P&G would also be able to establish rules to perform data validation without having to do double data entry.  Querying and data validation can be built within the EDC.  The EDC would also make data available immediately to the sponsor, whereas, with the current paper based process, the sponsor had to wait longer for the data to be available to them.   The EDC would require fewer visits from the sponsors to the sites, hence, providing a cost savings to P&G.

While the implementation of an EDC would potentially reduce the period of time needed to data lock from by half, it is still important to consider the other resources and changes that would be required in order to shift towards the EDC.  This alternative would require upfront investment in development and maintenance of all electronic case report forms (eCRFs) and help desk support for clinical sites.  Additionally, P&G would have to invest in training and change management to roll out the EDC to ensure sponsors, data entry specialists, and all others involved in the trial process would learn the new process.  It may take a longer period of time to adapt to the EDC given potential resistance to change, but in the long run, I would recommend that P&G implement the EDC as it will provide a wider range of benefits which will address the issue at hand which is the need to reduce the length of time it takes to data lock.

Reflection:

After attending Montclair consultant's presentation and listening to their point of view regarding the alternatives to resolve current issue at our hand, I agree with the recommendation of implementing EDC.  The implementation of the EDC is likely to be a rewarding investment for us.   EDC will enable us to be able to reduce the time it takes to data lock and potentially reduce the overall trial process time.

My initial recommendations were also confirmed by Montclair consultants, as implementing an EDC system will not only help us to contain costs and increase efficiencies within an organization, but it will also help with the clinical data management process. An EDC system will be a vehicle for exploiting new drug development opportunities by knowing sooner whether to move forward on or eliminate a drug program. EDC system will help us in managing the clinical data process and capture the information needed to help expedite this process and ultimately bring down the data locks time. Though the risks associated with implementing an EDC system includes investment costs associated with instituting the software, employee training and system maintenance the overall benefits are too lucrative for us and the same inclines my recommendation of implement EDC.