Veeva Systems Case Studies Illumina Streamlines Study Builds and Eliminates Regression Testing with Veeva Vault CDMS

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	Illumina Streamlines Study Builds and Eliminates Regression Testing with Veeva Vault CDMS Veeva Systems

Illumina Streamlines Study Builds and Eliminates Regression Testing with Veeva Vault CDMS

Veeva Systems

Applicable Functions	Quality Assurance
Use Cases	Experimentation Automation Rapid Prototyping
Services	System Integration Testing & Certification
Challenge	Illumina, a leading biotechnology company, was facing significant challenges in managing their study builds. The traditional process involved authoring and reviewing specifications for over three months, after which the Contract Research Organization (CRO) would build the database. This process was not only time-consuming but also lacked efficiency and agility. The study team would then review the specifications, which was a manual, paper-based process. Additionally, Illumina was conducting 100% regression testing during User Acceptance Testing (UAT), which was a significant burden. The company was also running a COVID-19 diagnostics trial during the pandemic, which required great flexibility and rapid changes. Read More
About Customer	Illumina is a global biotechnology company that specializes in DNA sequencing and array-based technologies. The company provides a line of products and services that serve the sequencing, genotyping and gene expression, and proteomics markets. Its products are used by a broad range of academic, government, pharmaceutical, biotechnology, and other leading institutions around the world. Illumina's mission is to improve human health by unlocking the power of the genome. The company was facing challenges in managing their study builds and was seeking a solution that could streamline the process and improve collaboration within the team. Read More
Solution	Illumina adopted Veeva Vault CDMS to streamline their study builds and improve collaboration within the study team. With Veeva Vault EDC, the company eliminated the need for manual, paper-based specifications. Instead, rapid prototyping was done directly within the system, and the Vault EDC auto-generated the specifications. This empowered the data managers to configure Case Report Forms (CRFs), visit structures, and basic rules, reducing the need for extensive programming. The study team was able to review the system online, which facilitated better engagement and feedback. Furthermore, Illumina was able to eliminate regression testing during UAT with Veeva Vault EDC. The system generated a 'Differences Report' that documented every change, allowing the team to only test the changes. This significantly reduced the UAT burden and added no additional risk. Read More Log in to view content
Contents

Applicable Functions

Quality Assurance

Use Cases

Experimentation Automation

Rapid Prototyping

Services

System Integration

Testing & Certification

Challenge

Illumina, a leading biotechnology company, was facing significant challenges in managing their study builds. The traditional process involved authoring and reviewing specifications for over three months, after which the Contract Research Organization (CRO) would build the database. This process was not only time-consuming but also lacked efficiency and agility. The study team would then review the specifications, which was a manual, paper-based process. Additionally, Illumina was conducting 100% regression testing during User Acceptance Testing (UAT), which was a significant burden. The company was also running a COVID-19 diagnostics trial during the pandemic, which required great flexibility and rapid changes.

About Customer

Illumina is a global biotechnology company that specializes in DNA sequencing and array-based technologies. The company provides a line of products and services that serve the sequencing, genotyping and gene expression, and proteomics markets. Its products are used by a broad range of academic, government, pharmaceutical, biotechnology, and other leading institutions around the world. Illumina's mission is to improve human health by unlocking the power of the genome. The company was facing challenges in managing their study builds and was seeking a solution that could streamline the process and improve collaboration within the team.

Solution

Illumina adopted Veeva Vault CDMS to streamline their study builds and improve collaboration within the study team. With Veeva Vault EDC, the company eliminated the need for manual, paper-based specifications. Instead, rapid prototyping was done directly within the system, and the Vault EDC auto-generated the specifications. This empowered the data managers to configure Case Report Forms (CRFs), visit structures, and basic rules, reducing the need for extensive programming. The study team was able to review the system online, which facilitated better engagement and feedback. Furthermore, Illumina was able to eliminate regression testing during UAT with Veeva Vault EDC. The system generated a 'Differences Report' that documented every change, allowing the team to only test the changes. This significantly reduced the UAT burden and added no additional risk.

Impact #1	The adoption of Veeva Vault CDMS has significantly improved Illumina's operational efficiency. The study team members are now more engaged, leading to higher-quality collaboration and reviews. The system has also reduced the number of UAT findings, indicating an improvement in the quality of the builds. Furthermore, the company has gained greater agility during the trial. For instance, during a COVID-19 diagnostics trial, Illumina was able to quickly adapt to a supply shortage of nasal swabs by making a post-production change to the ID format for swabs in just one day. This demonstrates the flexibility and responsiveness of the system in handling unexpected changes.

Impact #1

The adoption of Veeva Vault CDMS has significantly improved Illumina's operational efficiency. The study team members are now more engaged, leading to higher-quality collaboration and reviews. The system has also reduced the number of UAT findings, indicating an improvement in the quality of the builds. Furthermore, the company has gained greater agility during the trial. For instance, during a COVID-19 diagnostics trial, Illumina was able to quickly adapt to a supply shortage of nasal swabs by making a post-production change to the ID format for swabs in just one day. This demonstrates the flexibility and responsiveness of the system in handling unexpected changes.

Benefit #1	Cut study build times from 6 months to 1 month
Benefit #2	Eliminated the need for regression testing during UAT
Benefit #3	Implemented post-production changes in as quickly as one day during trials

Benefit #1

Cut study build times from 6 months to 1 month

Benefit #2

Eliminated the need for regression testing during UAT

Benefit #3

Implemented post-production changes in as quickly as one day during trials

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Overview

Illumina Streamlines Study Builds and Eliminates Regression Testing with Veeva Vault CDMS

Operational Impact

Quantitative Benefit