Illumina Streamlines Study Builds and Eliminates Regression Testing with Veeva Vault CDMS
Applicable Functions
- Quality Assurance
Use Cases
- Experimentation Automation
- Rapid Prototyping
Services
- System Integration
- Testing & Certification
About The 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.
The 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.
The 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.
Operational Impact
Quantitative Benefit
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