Domains
IT Solutions for Life Science Companies
Optimize performance, ensure data integrity, and maintain continuous compliance while reducing risk and fostering innovation.
Regulatory Compliance and Data Integrity
Ensure data integrity, audit readiness, and regulatory compliance throughout the IT lifecycle, using robust data validation, audit trails, and proactive quality control measures to meet stringent regulations.
System Integration and Data Accessibility
Eliminate data silos to ensure seamless data flow, enhance system interoperability, and enable cross-functional collaboration for optimized efficiency and compliance across IT and business operations.
Cybersecurity and Data Protection
Prioritize data protection to safeguard sensitive information against cyber risks with advanced security protocols, including encryption, continuous monitoring, and multi-factor authentication to ensure compliance and safety.
Managed IT Solutions
USDM delivers customized IT solutions for life sciences that ensure performance, security, and regulatory alignment. Our managed IT solutions for life sciences include 24/7 system monitoring, maintenance, cybersecurity, and compliance management. As a trusted IT provider for life sciences companies, we support scalable, GxP-aligned life sciences IT services.
Unmatched Industry Expertise
With unmatched industry expertise, USDM delivers tailored solutions that modernize compliance and technology, ensuring seamless regulatory adherence while optimizing processes and driving operational excellence. We empower life sciences companies to achieve their most ambitious goals, bringing transformative therapies to market and helping humans thrive.
IT Use Cases in Life Sciences
Regulatory Compliance & Validation Automation
Achieve continuous compliance and validation for cloud-based applications with USDM’s Cloud Assurance. Learn more.
Data Accessibility & Transparency
Implement data lakes and data warehouses to store and manage structured and unstructured data. Read this case study.
Regulated Data Integrity
Protect and monitor data quality across systems with a data integrity framework from USDM. Read the blog.
Cybersecurity & Risk Management
Prevent data breaches with features like encryption, multi-factor authentication, and continuous monitoring. Learn more.
GxP ITSM Workflow Automation
Create unified workflows across departments for real-time visibility and operational efficiency. Read this case study.
AI-Driven Clinical Data Management
Learn how to extract actionable insights from large volumes of clinical trial data with AI models built by USDM. Read the case study.
Life Sciences Information Technologies
IT Services for Life Sciences
Save time and money with capabilities offered by USDM, which include:
- System Validation: Validate critical IT systems—including CTMS, EDC, and eTMF—against FDA, EMA, and GCP regulations to support GxP-aligned compliance.
- Data Integrity and Quality Management: Ensure data accuracy, traceability, and consistency across the lifecycle of clinical and commercial information systems.
- Risk-Based Monitoring: Identify and resolve quality risks early with proactive monitoring aligned to GxP best practices.
- Standard Operating Procedure (SOP) Development: Develop and maintain SOPs that govern IT processes in compliance with regulatory standards.
- Change Management and User Training: Support successful technology adoption through structured change initiatives and end-user training programs.
- Vendor and System Evaluations, Selection, and Management: Evaluate, select, and oversee IT vendors and systems to ensure regulatory fit and long-term performance.
- IT Workflow Automation: Automate manual tasks across IT and commercial operations to reduce errors, accelerate timelines, and improve efficiency.
- System Integration and Interoperability: Enable seamless data flow between systems like CTMS, QMS, ERP, and more—ensuring operational connectivity across platforms.
- Cloud Assurance for IT Systems: Maintain audit-ready, compliant cloud environments with USDM’s Cloud Assurance framework designed for regulated industries.
- Cybersecurity and Data Protection: Implement strong data security protocols for clinical and commercial systems, ensuring compliance with GDPR, HIPAA, and industry-specific standards.
- GxP-Compliant DevOps for IT Applications: Deploy new technologies rapidly and securely with GxP-ready DevOps frameworks that support automation, AI, and innovation.
- eTMF Optimization: Enhance eTMF platform efficiency and documentation traceability for compliance and improved document lifecycle management.
- System Design, Implementation, Validation, and Release Management:
- Electronic Trial Master File (eTMF)
- Electronic Data Capture (EDC)
- Clinical Trial Management System (CTMS)
- Electronic Patient-Reported Outcomes (ePRO)
- Electronic Document Management System (EDMS)
- Interactive Response Technologies (IRT/IVRS)
- Electronic Common Technical Document (eCTD)
- Clinical Data Warehouses
- Safety Databases
- Secure Data Servers
Technology-Driven IT Solutions
As a trusted IT provider for life sciences companies, USDM enables innovation through automation, integration, and cloud assurance. Our custom IT solutions for life sciences combine GxP compliance with forward-thinking technology and life sciences capabilities to improve performance, security, and scalability.
FAQs for Life Science Companies Seeking IT Providers
Life sciences companies should choose an IT provider for life sciences companies that understands GxP requirements, offers validated systems, supports continuous compliance, and specializes in custom IT solutions for life sciences. USDM provides tailored life sciences IT services with a strong focus on regulatory alignment, data integrity, and long-term scalability.
USDM’s IT solutions for life sciences include advanced cybersecurity protocols, continuous monitoring, and risk-based controls that ensure data privacy in regulated cloud environments. Our life sciences IT services align with HIPAA, GDPR, and GxP standards to safeguard sensitive data while supporting performance and innovation.
Validating IT systems begins with risk assessment and includes requirements definition, test planning, execution, documentation, and audit preparation. USDM delivers end-to-end IT solutions for life sciences with built-in validation frameworks that meet GxP expectations and ensure systems are inspection-ready from day one.
Managed IT solutions for life sciences streamline digital transformation by maintaining system performance, enabling automation, and supporting scalable technology solutions without compromising compliance. USDM’s expert team delivers proactive management, system optimization, and information technology governance tailored for life science technologies.
Best practices include planning for interoperability, validating data flow, securing integrations, and minimizing disruption to operations. USDM’s custom IT solutions for life sciences ensure seamless system integration, regulatory alignment, and optimized performance across legacy and modern platforms.
USDM provides IT solutions for life sciences with built-in compliance monitoring, automated reporting, and system validation support to maintain continuous audit readiness. Our life sciences IT services ensure every system is secure, documented, and aligned with regulatory expectations—ready for inspection at any time.
Contact our team to discuss optimizing your technology and GxP workflows today.
