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CASE STUDY
CENTRALIZED REPOSITORY FOR CLINICAL TRIAL DATA

Learn how we helped this emerging life science company with building a digital landscape for their clinical trial data.

KEY PLAYER

Vice President, Information Technology, Biotechnology Company

BUSINESS ISSUE

SVA Life Sciences partnered with the VP of Information Technology at a biotech company to build a Digital Landscape to support their transition to a commercially focused, publicly listed organization. This company was lacking a Digital Landscape that could easily evolve as new systems were brought on and integrated, and to address additional business case needs that arose throughout the company's evolution. One identified need of the digital landscape was to establish a centralized repository for clinical trial data. This company needed a foundational framework and solution to manage, store and perform exploratory analysis in order to best support their clinical programs and to derive valuable insights to stakeholders.

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THE SVA PROCESS

SVA Life Sciences conducted a Data Inventory Assessment (DIA) of each contributing data source to identify key insights into how we would approach the company's clinical trial data management and to inform the initial development approach. We found that had multiple datasets from multiple CROs in multiple formats that needed to be cleaned and profiled in order to be used for analysis. We partnered with the organization's IT to establish a data lifecycle that leveraged capabilities of a data lake and data mart, coupled with cloud functionality to bring the data to a clean, easily accessible state for analysis.

The main project goals included:

  • Ensure the organization had full control of its business process and information in a highly distributed ecosystem of vendors, providers and business systems.
  • Integrate data from a variety of internal and external providers and systems.
  • Architect the solution in a manner that protects against the development of information silos that regularly exist within functions.
  • Accomodate rapidly changing business system processes or changes in the systems themselves.
 

BUSINESS OUTCOME

Using the centralized clinical data repository, the company increased efficiency in analysis and reporting, and was able to better inform trial designs and regulatory filings, inform strategy and messaging, and to prepare for partnerships and M&A discussions. The company was especially pleased that the transition of the centralized system to feeding pre-existing dashboards was seamless and uncomplicated.

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