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"We have been very pleased with Fastphase's service level and support.
Our protocol was implemented in the software in a matter of days, including
all the edit checks, and it was delivered well in advance of the trial
start date. Fastphase's efficient and intuitive interface required almost
no training on our part. Our staff was up and running immediately."
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CASE STUDY: Medical Device Company
CLIENT:
This client is a leading medical device company conducting a clinical
trial to test the effectiveness of a newly introduced medical device.
BUSINESS CHALLENGE:
Sponsor's challenge was to identify a solution that could provide early
trend analysis from early data capture. The solution had to allow for
the capture of data during and after the trial. The solution needed to
be more intuitive than paper CRFs and to require little or no training
of MDs and clinicians.
FASTPHASE SOLUTION:
Fastphase solution was selected for its very intuitive interface, its
fast implementation and deployment, its low IT requirements, and above
all its ability to view, report and analyze data. Fastphases solution
was delivered as a full ASP software application hosted and managed remotely
and requiring absolutely no new IT investment from the sponsor.
TECHNOLOGY:
A Builder was used to design the interface from the existing protocol.
The interface design included number of visits, tests to perform, forms
to fill, edit checks definition, reports, number of users, role and privileges
assignment, and more. All these components were designed to be reusable
in future trials. The software was automatically deployed to each user
so it could be used in an online and offline fashion.
METRICS:
The interface was designed in 2 days and the trial was ready to go in
one week. The sponsor had absolutely no new IT investment to incur. Sponsor
was able to leverage early data analysis from sites, and gather more complete
data. Data was automatically cleaned. Sponsor time saved was about 40%
compared to a typical CRF paper trial used today. More importantly, the
sponsor was able to analyze trends early on, and make effective decisions.
BUSINESS OUTCOME:
100% sponsor satisfaction. The application was implemented and delivered
very quickly allowing the sponsor to be up and running prior to the scheduled
trial. The intuitive interface required very little training and accounted
for 100% investigator retention. Protocol changes and software enhancements
were implemented and deployed the same day they were requested. The integrated
communication tools increased communication between all the clinical trial
stakeholders (between sponsor and investigators, CRAs and investigators,
data managers and CRAs, etc.) This increased communication was a significant
factor in speeding up the overall trial.
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