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Case for XML
Problem:
A large pharmaceutical sponsor planned to run a marketing awareness
program to support a new drug launch. The sponsor wanted to appeal
to the broadest possible base of customers, so the decision was made
to use phone, web and paper for data input. In order to appropriately
enroll the respondents with no data duplication problems, the separate
vendors selected for web,scanning and interactive voice services all
required real-time access to enrollment and fulfillment data in different
formats. Additionally, the customer required the ability to run enrollment
and fulfillment reports on an ad hoc basis.
Solution:
As this study launched prior to the initial introduction of Web
Services, few standards were available for providing remote access
to data and business logic over the Internet. The solution provided
real-time data exchange by exposing business logic via remote XML
commands. With this data exchange in place, the vendors effectively
replicated data into multiple schemas to support the study operations
and reporting requirements.
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Case for System Integration
Problem:
A major pharmaceutical sponsor desired to collect data from an international
population via mobile and web devices for a phase IV trial. To improve
compliance, it was determined that the data collection vendor would
send messages back to patients through the mobile connection.
Solution:
The data was collected in Europe via internationalized (multilingual)
WAP and Web interfaces. Patient specific messages generated by the
data collection vendor were sent via SMS through the mobile vendor’s
facilities. At the end of the trial, the data collected was aggregated
and provided to both the e-clinical and e-marketing departments.
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Case for Web Services
Problem:
A technology-based clinical trial vendor required a product architecture
capable of supporting multiple input devices, partner interactions
and extensions and online/offline data collection.
Solution:
GTNet, Inc. has provided this vendor with multiple options for solving
each of the requirements while conforming to 21 CFR part 11 and
HIPAA. The final solution will involve XML Web Services, CDISC,
XML native databases and a complex distributed messaging system.
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