Fellow C-Levels,
Subsequent to American A Experts presentation and advisement
concerning our electronic data capture during clinical trial management I offer
the following. I agree with American A
Experts opinion that our current data collection system which originates on
paper at the investigation site is archaic and inefficient. Because of our antiquated data collection
process we’re missing an opportunity to expedite the delivery of new products
to market. As you are all aware each day
of delay in market entry of a new product costs us approximately $1,000,000.00.
To avoid market entry delays we must increase the efficiency
of our data capturing process. It is my
recommendation that we implement, as suggested by American A Experts, a web
enabled electronic data collection system.
We all know a global roll out of a web based data collection system will
come with challenges and will be met with resistance at some investigation
sites. However it is imperative that we implement
the web based system globally to avoid operating two independent systems as our
internal infrastructure is insufficient to meet the demands of two data
collection processes. My recommendation
is supported by the concept of efficiency.
When data is entered electronically at the investigation sites the data
collection process is streamlined and we eliminate inefficiencies. Some of the inefficiency we eliminate include,
double entry of data, inaccurate entry of data, delays in data lock due to
improper inclusion of candidates and lag time in overall data review process. Implementation of a web based electronic data
collection system will eliminate the items discussed above, expedite the market
delivery of new products and have a profound effect on our ROI.
Investigation site opposition to the conversion will be
overcome by providing each site with the necessary hardware to collect the data
and proper training and help desk support.
Training will be conducted biweekly for 2 months and monthly for the
next 4. Help desk support will be
provided free of charge for the life of the program. The costs incurred to implement and support the
web based electronic data collection system are far outweighed by the cost
savings and revenue generation of expediting the market delivery of our new
products.
No comments:
Post a Comment