Challenge
A global biotechnology company specializing in antibody therapeutics for cancer treatment faced critical data challenges that threatened both operational efficiency and regulatory standing. Disparate data management practices had created inconsistencies and inefficiencies, while regulatory requirements—including GxP and GDPR—exposed real vulnerabilities in data security and integrity.
- Lack of standardization: Fragmented data practices produced inconsistent, hard-to-trust results.
- Compliance risks: GxP and GDPR obligations highlighted gaps in security and integrity, increasing exposure to audit and inspection findings.
- Data access issues: Limited data democratization slowed decision-making and cross-team collaboration.
- Operational costs: High maintenance and compliance overhead strained resources.
Approach
USDM partnered with the biotechnology company to design and implement a secure, compliant, and scalable data platform on AWS. The architecture was validated for GxP and GDPR from the outset, applying a risk-based assurance approach so that controls—not paperwork—drove the effort.
Centralized data lake
- Used AWS S3 and Lake Formation to centralize all structured and unstructured data into a single source of truth.
- Enabled advanced data mining and unstructured data analysis for the company's data scientists.
Validated, compliant architecture
- Designed a GxP- and GDPR-compliant platform engineered to protect data integrity end to end.
- Automated workflows for consistent data governance and compliance reporting.
Built-in security
- Integrated robust encryption, access controls, and audit trails to safeguard clinical trial and biomarker data, aligned with life sciences cybersecurity best practices.
Cost optimization
- Reduced maintenance, security, and compliance costs through cloud-based automation and scalable architecture.
Results
The validated AWS data lake transformed how the organization managed, secured, and used its data.
- Compliance and risk management: Achieved 100% GxP and GDPR compliance, reducing audit and inspection risks and improving regulatory transparency through automated compliance features.
- Operational efficiency: Streamlined data management, reducing manual effort by 30% and accelerating data access and analysis by 50% for faster decision-making.
- Cost savings: Lowered maintenance and compliance costs by an estimated 25%, saving approximately $150,000 annually.
- Data accessibility and insights: Established a single source of truth that delivers consistent, reliable insights and democratizes data access across the organization to fuel collaboration and innovation.
By pairing modern AWS services with a validated, continuous-compliance foundation, USDM helped this biotechnology company cut costs, improve transparency, and unlock data-driven innovation in a highly regulated environment—proving that compliance and agility can advance together. Talk to USDM about building a compliant data platform for your clinical and research data.