Summary
Key results
Increased user satisfaction with the new clinical management system
Standardized and optimized clinical trial and studies management processes
Legacy systems limiting compliance and clinical efficiency
In the highly regulated biotech and healthcare industry, clinical study management must ensure strict regulatory compliance, full data integrity, and consistent quality standards. For a global provider of cancer treatments and in-vitro diagnostics, legacy systems were no longer sufficient to support these requirements across global operations.
The existing landscape limited operational efficiency and made it harder to maintain the desired level of quality and regulatory alignment across clinical trials. To address these constraints, the company decided to replace its legacy tools with Veeva Clinical Vault – a comprehensive platform designed to standardize and strengthen clinical studies management.
Given the scale of the transformation and the critical role of clinical data, the client required structured Business Analysis and rigorous Quality Assurance to ensure that the new system would fully support compliance, efficiency, and quality objectives.
The company engaged Sii as a technology partner, leveraging its strong expertise in Testing Services and regulated healthcare environments.
End-to-end implementation of Veeva Clinical Vault
To ensure a controlled transition from legacy systems to Veeva Clinical Vault, Sii delivered structured Business Analysis and comprehensive Quality Assurance services, covering the entire implementation lifecycle. The goal was clear: deploy a compliant, efficient clinical studies management system without disrupting ongoing operations or compromising data integrity.
Sii’s experts supported the client from the early stages of the project through to production stabilization. Working in an Agile delivery model ensured alignment between business requirements, system configuration, and validation processes.
The scope of work included:
- Conducting Business Analysis to define requirements and align system functionalities with clinical and regulatory needs
- Supporting initial development and early-stage testing to validate system configuration
- Executing official System Acceptance Testing (SAT) to confirm readiness for production
- Managing final deployment and go-live activities
- Providing on-site hypercare support at the client’s office to ensure smooth stabilization of the new environment
As a result, the implementation of Veeva Clinical Vault was delivered in a structured and controlled manner, fully aligned with the client’s objectives for operational efficiency, regulatory compliance, data integrity, and quality assurance in clinical studies management.
Stronger compliance, higher data quality, and streamlined clinical operations
The implementation of Veeva Clinical Vault provided the client with a structured and standardized environment for managing clinical studies. Processes that were previously limited by legacy systems are now aligned within a single, comprehensive platform, improving transparency and control across clinical trial activities.
From a technical perspective, the client optimized the way clinical trials and studies are managed. Business and testing processes – including the User Story lifecycle – were simplified and standardized. Sii also developed a dedicated data quality testing strategy and delivered a Proof of Concept of a new automation approach using Robot Framework, creating a foundation for further test efficiency improvements.
From a business standpoint, the organization achieved greater process simplicity, improved data quality and integrity, and higher user satisfaction.
With stronger validation mechanisms and structured Quality Assurance in place, the client reduced regulatory risk and strengthened confidence in the accuracy and reliability of clinical data.
Key results
- Standardized and optimized clinical trial and studies management processes
- Simplified Business and Testing processes, including the User Story lifecycle
- Structured data quality testing strategy supporting data integrity
- Proof of Concept of automated testing using Robot Framework
- Improved data quality and integrity across clinical studies
- Increased user satisfaction with the new clinical management system