Dear Executive Board Members,
I would like to begin with apologizing for my absence; I fully
understand the importance of today’s meeting and have prepared my conclusion on
the presentation made to us yesterday. The
presentation was in regards to the implementation of a new method to be put forward
in P&G’s clinical trial process.
The consultants have given us three alternatives to solve
the existing issues in our current process involving the clinical trials. The first alternative, was to improve P&G’s
current paper based process by improving the current forms to be user friendly,
as well as, use daily shipping in order to receive the forms and have them
entered into the system in a timely matter.
The second alternative, would be to have all the forms faxed to our data
entry department which then would scan all the forms and save them digitally. This would make it easier on the trials sites
and could possible increase P&G’s number of clinical trial sites. The last alternative was slightly more
radical, it involved the implementation of Electronic Data Capturing. EDC would allow for accurate data capturing,
as well as, the clinical trial process time being cut by half.
With these alternatives there are both pros and cons
involving each one of them and the consultants were very adamant on making sure
we fully understood them. So I would
like to point out the some pros and cons that were would best suit us on our
decision.
The improvement on our current paper based process by
creating easier forms to be used will for certain keep P&G’s costs stable. As the clinical trial sites are all trained
on this method the cost to us will remain the same we are currently paying. Which as of now we incur an expense of
$785,000 for 20 sites, with 10 patients for a period of 12 months, as the
consultants pointed out. However, the
time it takes for products to go through the clinical trial stage and for the
data to be entered and locked up for analysis in the systems is still lengthy as
would not be solved with this improvement.
With the digitized format, P&G could potentially
receive more interest from trial sites which are not involved in our clinical testing,
since they will be attracted by the simpler process. However, the forms remain the same, but
additional pressure is place on us internally as now we have to scan the data
into the system instead of entering the data.
This would increase our costs as the process at the trial sites would
remain the same, our internal personnel would still be required to enter the
data, though now we would have to invest in additional storage memory to all
for all the forms to be saved as an image.
Another cost to be added will be the cost of paying someone to store our
data at their facility as backup. We will
have to find a third party who will enter into a contract with us, allowing us
to store our data at their facility in case of any natural or non-natural disasters
which could occur.
Lastly but not least, the use of electronic data capturing. This is the alternative put forward by the
consultants as the best alternative since they believe it would be more costly
at the beginning of implementation but would decrease the clinical trial time
associated to the launching of new medical products. All data received would be entered into the
program which we will have to provide, teach the trial sites and maintain. This would allow us to cut costs associated
to the double data entry, as well as, costs associated to human error done at
the trial sites level. However, the
savings from those cuts, in the beginning of the implementation only, will have
to be put towards additional personnel to be used in training and system
maintenance. Trial sites will also
require internet access and computers, which in some cases P&G might have
to provide them with or we will start losing trial sites. The consultants provided us with a predicted
expense of $573,400 for using EDC, which is an estimated savings of $211,600
from the paper based expense of $785,000.
There might have been a few things overlooked when
estimating the expense of implementing EDC in the beginning stages before it stabilizes. But in the long run, the expenses will become
even less than indicated by the consultants.
Overall they have presented us with a great presentation and
made it a difficult decision to make. From
the beginning our goal was to minimize the time it took one of our medical
products to be launched into the market in order to decrease the loss of
potential sales. With this being our
goal, I would have to recommend the implementation of EDC. The initial costs with EDC will be greater,
but will be compensated by the additional sales of the product, which we have
all heard that the $1 million in lost sales is estimated for each day the
launch of a drug is delayed.
With this, I would like to apologize for not being at the
meeting today, and hope you take into consideration my conclusion of the
consultants presentation and solution to the matter.
If there are any questions please let me know as I will be
more than happy to answer them and provide additional feedback if required.
Sincerely,
Jennifer Couto
No comments:
Post a Comment