SUCCESS STORY
Leading pharmaceutical company
Industry• PharmaceuticalSolutions• OpenText™ Alloy™

Leading pharmaceutical company
improves clinical trial capacity andtime to value

Global Life Sciences organization speeds flow of mega clinical trial dataand supports timely, multi-trial analysis with OpenText Alloytimes andincreases profit and growth with OpenText.
Results
Sped data cycle
by approximately 70 percent
Cut operational expenses
with changes in data structure
Increased capacity
for clinical trials supporting
new drug pipeline

Leveraging OpenText
Alloy enabled a leading
pharmaceutical companyto reduce time required toflow clinical trial data used
for analysis from 125 days
to 39 days.

Leading pharmaceutical company improves clinical trial capacity and time to value

A mega clinical trial strained existing clinical trial data
infrastructure at this leading pharmaceutical company,
creating inconsistent data flow for analysis. With the megatrial representing 50 percent of all clinical data collected for
one year, data flow for other clinical trials was delayed, reducing
the efficiency of the company’s overall clinical trial program.
Although the pharmaceutical company’s systems had theinfrastructure in place to accommodate standard, small to medium
clinical data trials, a mega trial brought new challenges that thecompany’s legacy processes and tools, including its data-mapping
tool, could not support. While even standard trials needed efficiency
improvements in their data flow processes, the magnitude of the megatrial caused inconsistent data flow for analysis purposes. The company
was using a single map for all data that had to be deposited in theclinical data repository. Because of the scope of the mega trial, themap size was extraordinarily large. Every time there was a change inthe study, the company had to change the map, regardless of the size
or significance of the change. Frequent changes meant there werecontinuous changes in the map, which prevented movement of data.

• Redesign the data flow work process and technical mapping
components to make them scalable.
• Implement a solution that would support the use of cloud-based
services in future clinical trials.
OpenText analyzed the data flow problems and developed a complete
solution, which included:• New streamlined and optimized map development, testing anddeployment processes.
• A hosted, scalable, run-time system capable of scaling to morethan 200 clinical trials simultaneously.
• A library of standard forms-based maps that could be used
repeatedly, enabling more efficient and consistent data flow.
• Integration to Study Data Tabulation Model (SDTM) compliant
data sets.
•Training for the company’s offshore contract researchorganization (CRO) on the newly developed system.

• Reduce the number of days required to flow clinical trial data used
for analysis.

Based on the success of a six-month pilot of OpenText™ Alloy™,
the pharmaceutical company decided to implement the solution
for interface mapping in all future clinical trials. Since then, thecompany has realized a vast improvement in clinical trial data flow
and additional business efficiencies, including:• Streamline the mapping of key clinical trial data to standard formats.

• Improved timing. Cycle time was reduced from 125 days to 39 days.

• Reduce costs by accelerating and streamlining processes and using
offshore resources more efficiently.

• Reduced costs. The number of mapping resources required tosupport the trials was reduced due to changes to data structure
and less reworking. Resource allocation improvements provided
a further reduction in employee related operational expenses.

When enlisting the help of OpenText, the pharmaceutical company
established clear and specific project objectives, including:• Enhance data quality to improve reliability and completeness of theclinical data repository.

More trials can now be
conducted simultaneously,supporting an increasing
new drug pipeline.

Leading pharmaceutical company improves clinical trial capacity and time to value• Accelerated data flow processes. Map creation efficiencies reduced
the average map development process time, and standardizationencouraged more efficient utilization of staff resources.
• Improved problem resolution. Trending errors were reduced
by replacing a sequential error identification and resolution processwith a more dynamic process.
• Greater capacity for clinical trials. More trials
can now be conducted simultaneously, supporting
an increasing new drug pipeline.
• Improved data quality. Data manipulation decreased by 25 percent
through automated error capture and handling.

• Easier assimilation of acquisitions. Easier support of clinical
trial growth and volume that results from business acquisitions.
As the pharmaceutical and biotech industries continue to face new
trends and challenges that hasten the tempo of business, innovation
has become the most important precursor to improving profitability.
The ever-increasing volume of data from clinical trials, as well asother sources, adds to the complexity of managing research anddevelopment. The leading pharmaceutical company’s decision toinvest in a scalable, flexible solution from OpenText that can continue
to expand as the company’s needs expand, positions it well to keep
up with the accelerated pace of the industry.

• Decreased disruptions. Data flow disruptions reduced from anaverage 19 percent of active trial days to 6 percent.

About OpenText
OpenText, The Information Company,enables organizations to gain insight
through market leading information
management solutions, on-premises orin the cloud. For more information about
OpenText (NASDAQ: OTEX, TSX: OTEX)
visit opentext.com.
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