Domain

Information Technology in Life Sciences

Automation, cybersecurity, and managed services help life sciences companies maintain regulatory compliance across their IT landscapes.

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.

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.

Pharmaceuticals

Biologics & Biotechnology

Medical Device & SaMD

CRO/CMO

Other

IT Use Cases in Life Sciences

Regulatory Compliance

Achieve continuous compliance and validation for cloud-based applications with USDM’s Cloud Assurance.

Data Accessibility

Implement data lakes and data warehouses to store and manage structured and unstructured data.

Data Integrity

Protect and monitor data quality across systems with a data integrity framework from USDM.

Cybersecurity

Prevent data breaches with features like encryption, multi-factor authentication, and continuous monitoring.

System Integration

Create unified workflows across departments for real-time visibility and operational efficiency.

Data Protection

Mitigates potential threats in real-time with a comprehensive cybersecurity framework from USDM.

Life Sciences Clinical Technologies

GxP IT Services for Pharma, Biotech and Medical Device Companies

Save time and money with capabilities offered by USDM, which include:

Clinical System Validation: Ensuring that IT systems like CTMS, EDC, and eTMF meet regulatory compliance standards, including FDA, EMA, and GCP requirements.
Data Integrity and Quality Management: Supporting the management and integrity of commercial data to ensure accuracy, traceability, and consistency throughout the study lifecycle.
IT Workflow Automation: Automating routine commercial workflows to reduce manual effort, minimize errors, and accelerate commercial timelines.
Data Integrity and Quality Management: Supporting the management and integrity of data to ensure accuracy, traceability, and consistency throughout its lifecycle.
Risk-Based Monitoring: Implementing risk-based monitoring approaches to proactively address quality issues.
System Integration and Interoperability: Integrating IT systems with enterprise tools, ensuring seamless data flow, interoperability, and cross-functional collaboration.
Cloud Assurance for IT Systems: Providing continuous compliance for cloud-based systems with USDM’s Cloud Assurance to maintain audit readiness.
Clinical Data Security: Implementing security protocols for clinical data, ensuring protection and compliance with regulations like GDPR and IPAA.
Change Management and User Training: Managing change initiatives and providing training to ensure effective adoption of new clinical systems and workflows.
GxP Compliant DevOps for IT Applications: Developing compliant DevOps frameworks for IT applications to scale AI initiatives, ensure GxP adherence, and streamline development.
Electronic Trial Master File (eTMF) Optimization: Supporting the implementation and optimization of eTMF systems to enhance documentation management and ensure regulatory compliance.
Standard Operating Procedure (SOP) Development: Developing SOPs to ensure compliant and consistent IT processes aligned with regulatory standards.
Vendor and System Evaluations, Selection, and Management: Evaluating, selecting, and managing IT systems and vendors to ensure compliance and optimal performance.
System Design, Implementation, Validation, and Release Management for:
- Electronic patient-reported outcomes (ePRO)
- Electronic document management system (EDMS)
- Electronic common technical document
- Clinical trial management system (CTMS)
- Interactive response technology (ITR)
- Interactive Voice Response System (IVRS)
- Electronic data capture (EDC)
- Electronic trial master file (eTMF)
- Clinical data warehouse
- Secure data server
- Safety database and more