SUCCESS STORY
Contract research organization
Industry• Life sciences

Solutions• OpenText™ Alloy™
• OpenText™ Lens™
• OpenText™ Managed Services

Results
Ensured data security andcompliance, meeting the needsof pharmaceutical organizations
Improved onboardingof new sponsors
Sped delivery of EDC data via
automated processing andupload to sponsor systems
Reduced strain on IT resources bytransferring data in native form

Contract research organizationdelivers timely, high-quality datawith OpenText Alloy

CRO achieves realtime EDC uploads and fast sponsor onboarding
OpenText addressed theinherent complexities ofconforming to varying
sponsor-specific data anddelivery requirements.

Contract research organization delivers timely, high-quality data with OpenText Alloy

Contract research organizations (CROs) submit electronic data
capture (EDC) data to many pharmaceutical sponsors. Eachsponsor generally imposes differing data requirements, distracting
CROs from their core business mission.

developing a solution that allows the CRO to hand off its EDC datain native form. The native data is processed and validated between
the CRO and OpenText through the implementation of a standard
canonical map.

One CRO engaged OpenText to shield it from this distraction. As
a result, OpenText implemented a fully managed solution on theOpenText™ Alloy™ platform to collect data in native form from the CRO,transform it into various sponsor-required formats and deliver thedata via sponsor-preferred communications protocols, securely andin realtime. The solution allows the CRO client to meet the varying
needs of its sponsors and provide them with timely, high-quality data
in a compliant manner.

OpenText then takes the validated canonical data and transforms
it into sponsor-specific formats. This approach enables reuse ofthe core data processing logic from one sponsor to another byimplementing it on top of the canonical map. Additionally, OpenText™
Lens™ provides the CRO with end-to-end visibility across this data
flow so that status and outcome can be verified. OpenText™ Managed
Services, which consists of a combination of technology, processes
and people, further met the needs of the CRO client by protecting
highly skilled resources from the operational aspects of the solution.

Prior to implementing OpenText, the CRO client maintained a custom
in-house EDC solution to meet the requirements of its sponsors. Overtime, and as new sponsor requirements were added, the implications
for compliance, performance, operations, support and maintenance,
coupled with a scarcity of resources, made it prohibitive for the CRO
to continue with the solution.
Some of the key sponsor requirements included:• Offer EDC data in CDISC LAB data model format• Support for subsequent sponsor analysis, with data
conforming to strict data quality requirements• Uploading of incremental data feeds in realtime,through services exposed by various sponsor data
ingest platforms, without manual intervention
OpenText addressed the inherent complexities of conforming
to varying sponsor-specific data and delivery requirements by

In addition to meeting all sponsor requirements, the OpenText
solution helped the CRO realize several additional key benefits.
Cumulative EDC data feeds are converted to incremental feeds forsponsor systems, enabling accurate data lineage, a key requirement
for regulatory submission. The EDC data is now available in sponsor
systems within a matter of minutes through automated end-to-end
processing and upload. In addition, the onboarding of new sponsors,
and their data requirements, can be accomplished in a nimble
timeframe of just two to three months. Highly skilled employees are
now freed from the operational aspects of the former solution andcan instead focus on core CRO competencies. Finally, end-to-end
data flow is now transparent, making it easier to coordinate errors
and data issues across multi-enterprise teams.
The CRO is thrilled with the implementation and plans to leverage
more OpenText products in the future.

OpenText Alloy reduces
overall time spent by key
IT resources within theCRO team.

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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