Problem/Issue Statement:
The main issue is that Proctor & Gamble’s
health care division is facing delays in its Clinical Data Management
Process. P&G needs to brainstorm new ideas to help diminish the
time it takes to complete the process for clinical trials of prescription
drugs. Right now the process can take up to several years before the
prescription makes into the market. There is a claim that for "each day of
delay in market entry for the product costs the sponsor roughly $1M in lost
sales" (Harvard Business Review, Huckman & Cotteleer, 2006). This
means that the faster P&G can get their product on the market the faster
they can begin to turn a profit.
Currently, P&G relies on a paper-based
system for collecting all clinical patient information. This
paper system is the main cause of the delay issue. This process
actually causes patient information to be entered, checked and double checked
numerous times over varying time frames, which causes inaccuracies and
human errors to potentially go unchecked for weeks, leading to various delays.
And this is all before the trial has even been completed. Once all the data is
verified in the database it is locked and can no longer be edited or reviewed.
The time frame for the period between the data lock and the last
patient visit falls between 8-12 weeks. Having potentially incorrect data
sitting there for 8-12 weeks without the ability to modify causes long delays
in the entire process because of the freeze out of potential corrections
in the system. These delays and usage of additional manpower and time to
make corrections affects the entire clinical data management process and
it needs to be examined to help find ways to reduce the length of time and the
inconsistencies with the process.
Situation Assessment:
The main issue is with the paper-based system. This
portion of the system requires that all patient information is stored in hard
copy form. This process moves very slowly because it requires human entry on
both the hard copy and digital form for each page. The time it takes to enter
each page twice causes delays in time and costs more money. P&G needs
to find alternative solutions to help cut down wasted time and money. If they
find a way to create a system that avoids as many inaccurate data inputs and
revisions not only will it help cut down on the length of time the process
takes but it will also limit many hours and additional funds it takes to have
people fixing these mistakes. Plus, having a system that is efficient and
available to all divisions will help cut down on the time it takes to review
patient files and correct any mistakes by hand as well. On boarding the
Electronic Data Capture (EDC) is one option to reduce the number of errors and
lower the period of time to takes for the process to occur but a number of
other concerns must be addressed before P&G can total implement this
process.
List of Plausible Alternative Courses of Action:
There are three viable alternatives that can be
used to address the current ineffective process:
The first would be Improving the paper-based
system, which would include the use of express mail shipment from
investigator sites on a daily basis and it would also add extra man power to
perform system monitoring and the verification of data to help hurry
the process along. But this process only seems to deal with one aspect of
the problem, that of the time delays.
The second alternative would be the Digital Imaging
Process. This process essentially uses the same paper based system but it
would allow the transmit of data to be done through the use of faxes
rather than mail service. These faxes would then be stored and the data entry
would comprise of digital images rather than keeping hard copy forms in patient
binders. This option reduces the time spent on delivering and receiving hard
copy forms to various sites. The main issue that this process faces is the
availability and reliability of fax machines and the people working with
them.
The last option is Electronic Data Capture (EDC).
This process allows the data to be directly input into the electronic
system direct from the investigator site. This process would also allow
the site to create specific, clear-cut requirements that would be self-checked
by the database constantly to weed out patients that are not eligible
or pick-up on human entry errors. This would also allow the data to viewed
almost immediately after it has been entered allowing the time that
would have been taken to view these files by the checkers to be cut
drastically. This system seems to address all areas of the problem:
fixing the paper based system, cutting down on errors, the
physical movement of hard copy files, the double entry and manual double
checking issues all of which help reduce the total time of the process.
Assessment:
After reading the case my current assessment would
be to have P&G adopt of the EDC process because it seems to focus on
correcting and eliminating all the facets of the problem. Once the company and
its employees understand the system I believe it will make their whole process
run much smoother and will help eliminate double work.
Reflection:
As a response to the consultant presentation held last week to review
P&G's current system and explore other alternatives to help
improve system efficiency, cut down on cost and shorten the amount of time it
takes to enter the data lock phase I have analyzed each option on it's
ability to cure all aspects of our current issue. My recommendation is that
P&G should adopt the EDC method to help us eliminate both time and money
waste. At this point in the world I think being on the forefront of the Internet
and the use of electronic data capturing is going to help revolutionize our
business. Not only were the initial EDC trials successful but it showed a
reduction in errors in human data entry, it eliminate the time consuming
issue of double entry and it showed the amount of time taken between the
last patient visit and the data lock period cut in half. Since EDC would allow
us to work with more accurate patient data, enable a quicker time line and cut
down on unnecessary expense I find that this solution covers all of our bases
and allows us to be on the cutting edge of modernization and
technology.
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