Contract research organizations (CROs) submit electronic data capture. (EDC) data to many pharmaceutical sponsors. ... P
CRO RELIES ON LIAISON TO ACHIEVE REAL-TIME EDC DATA UPLOADS Liaison’s fully managed services approach buffers the complexities one CRO faced in submitting real-time EDC data to sponsors
CASE STUDY AT A GLANCE
Executive Summary
Company Leading contract research organization (CRO)
Contract research organizations (CROs) submit electronic data capture (EDC) data to many pharmaceutical sponsors. Each sponsor generally imposes differing data requirements, distracting CROs from their core business mission.
Industry Life Sciences Liaison Solution ALLOY Health™
One such CRO engaged Liaison to shield it from this distraction and its attendant complexities. As a result, Liaison implemented a fully managed solution on its ALLOY Health™ cloud platform that collects data in native form from the CRO, transforms the data into various sponsor-required formats, and delivers the data via sponsor-preferred communications protocols—securely and in real time. This allows our CRO client to meet the varying needs of its sponsors and, just as important, provides its sponsors with timely, high-quality data in a compliant manner.
Challenges: Lack of Agility and Resource Scaling for Current Custom-built Solution Prior to turning to Liaison, the CRO client maintained a custom inhouse EDC solution to meet the requirements of its sponsors. Over time, 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 down this path. Some of the key sponsor requirements were: •
Provide EDC data in CDISC LAB data model format
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To support subsequent analysis by sponsors, the data had to conform to strict data quality requirements
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Incremental feeds, which required CRO to ‘chunk’ its cumulative EDC system feed into incremental ones
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Uploading of incremental data feeds in real time, through services exposed by sponsors’ data ingest platforms, without manual intervention
Contact Us /
[email protected] / 1-866-336-7378 / www.liaison.com
CASE STUDY: LEADING CONTRACT RESOURCE ORGANIZATION (CRO)
Solution: ALLOY Health, Delivered as Managed Services, Buffers Complexities Liaison buffered the inherent complexities of conforming to varying sponsor-specific data and delivery requirements by developing a solution that allows the CRO to hand off its EDC data in native form. The native data is processed and validated between the CRO and Liaison through the one-time implementation of a standard canonical. Liaison then takes the validated canonical data and transforms it into sponsor-specific formats. This approach enables reuse of the core data processing logic from one sponsor to another by implementing it on top of the canonical. Additionally, the Liaison Enterprise Navigation System (LENS) provides the CRO with end-to-end visibility across this data flow so that status and outcome can be verified. Liaison’s managed services model, which consists of a combination of technology, processes, and people, further met the needs of our CRO client by protecting highly skilled resources from the operational aspects of the solution.
CRO
ALLOY Health
Error Resolution Support/Business User Groups
Sponsors Error Review
LENS Reconciliation Report App
Non-PII Data Points Only
Reference Data Update SFTP/FTPS
North America Data Management (Delta Processing, Canonical Processing, Validation)
Sponsor 1
Clinical Data (CDISC LAB/Etc.) EDC Data Hub
CDISC XML
CDISC XML Integration (Contivo/Messaging/API)
Sponsor 2
XML
Benefits: Sponsor Requirements Met with Less ‘Touch’ In addition to meeting all sponsor requirements, Liaison’s solution allowed the CRO to transfer its data in native form, thereby reducing the overall time spent by key IT resources within the CRO team. Below are several key benefits delivered by Liaison: •
Cumulative EDC data feeds converted to incremental feeds for sponsor’s system, thereby enabling accurate data lineage—a key requirement for regulatory submission
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EDC data is available in sponsors’ systems within a matter of minutes through automated end-to-end processing and upload
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Onboarding of new sponsors—and their data requirements—in a nimble timeframe of 2-3 months
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Highly skilled resources are freed from operational aspects of solution in order to focus on core CRO competencies
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End-to-end data flow is transparent through LENS, making it easier to coordinate errors and data issues across multienterprise teams
The Future: Complexity Buffer for All Sponsors This use case has become a model for data exchanged between Liaison’s CRO client and sponsors. As such, the solution leveraged for pilot sponsors will be scaled out to all sponsor relationships.
Contact Us /
[email protected] / 1-866-336-7378 / www.liaison.com
