Veeva Systems Case Studies GSK's Agile Approach to Clinical Data Management
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GSK's Agile Approach to Clinical Data Management

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GSK, a global healthcare company, was facing challenges in managing its clinical data due to the use of multiple Electronic Data Capture (EDC) systems and complex processes. The company was using at least four different types of EDCs within its clinical data ecosystem, each customized to such an extent that it resembled a jigsaw puzzle. This complexity was slowing down the process of data review and management. Additionally, the company was struggling with the proliferation of digital data sources as it embraced hybrid digital trial models. The need for effective data management had become a key driver of trial success. GSK also aimed to accelerate the delivery of life-saving treatments, a goal hindered by the existing complex data management system.
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GSK is a global healthcare company with a mission to help people do more, feel better, and live longer. The company produces a wide range of prescription medicines, vaccines, and consumer healthcare products. GSK is committed to widening access to its products, improving the way diseases are managed, and developing new treatments that will help to define the future of healthcare. The company is constantly exploring new ways to speed up the delivery of life-saving treatments and improve its operational efficiency. GSK's modernization project is a testament to its commitment to leveraging technology to enhance its operations and ultimately benefit patients.
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To address these challenges, GSK decided to implement Veeva CDB, a clinical database that speeds up data cleaning and standardization. This allowed GSK's data to be managed, reported, and analyzed more efficiently. The company also adopted Veeva Vault CDMS as its single, core Clinical Data Management (CDM) platform, avoiding customization and choosing a platform based on its inherent capabilities. This move towards a single platform aimed to improve data review and reduce complexity. The new system aggregates and harmonizes clinical data from every source to centralize cleaning and reconciliation. Additionally, GSK leveraged technology enablers such as AI and machine learning to support data cleaning and exploration, surfacing trial insights. The company also adopted an agile development process, which allowed it to complete the project in just 18 months.
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The implementation of Veeva CDB and the adoption of a single CDM platform have significantly simplified GSK's operating model. The company has been able to reduce the complexity that had built up over the years due to the use of multiple EDCs. The new system has also enabled GSK to leverage advanced tools such as AI and machine learning, making its data management processes more efficient and effective. The agile development process has allowed GSK to move faster and accelerate delivery, contributing to its goal of speeding up the delivery of life-saving treatments. The company's modernization journey is ongoing, with plans to continue collaborating with Veeva and other partners to continually improve its operations.
GSK completed the modernization project in just 18 months, half the time expected, due to an agile methodology.
The company aims to do at least 50 to 60% better than the current industry benchmark for delivery.
The new system allows for faster data cleaning and standardization, reducing the time taken for clinical study locks from 21 weeks to potentially as low as two weeks.
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