Domains

Accelerate Clinical Operations

Drive better business decisions with accurate and traceable data.

Ensuring your clinical trials are compliant, data is reliable, and workflows are efficient.

Data Integrity & Compliance

Maintain compliant, accurate, consistent, and traceable clinical data throughout its lifecycle. USDM ensures your organization adheres to rigorous regulatory standards and remains audit-ready, reducing risks and building trust. With robust validation frameworks and automated processes, you can eliminate inefficiencies, secure data integrity, and focus on innovation.

Data Integration & Interoperability

Seamlessly integrate data across critical clinical systems, including CTMS, eTMF, EDC, and LIMS, to enable smooth workflows and communication. USDM’s solutions foster collaboration between internal teams and external stakeholders like CROs and regulators, ensuring data accuracy and traceability. By breaking silos, we empower organizations to unlock actionable insights and accelerate decision-making across the clinical lifecycle.

Clinical Trial Operational Efficiency

Streamline your GxP IT systems and processes to effectively manage diverse data sources and multiple vendors. USDM supports compliance with evolving regulatory requirements while enhancing operational efficiency. With scalable solutions, you can reduce IT overhead, automate workflows, and ensure trial readiness, enabling your team to focus on delivering successful clinical outcomes

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

Clinical Use Cases in Life Sciences

Clinical Collaboration

Reduce the validation effort of your content management system by more than 50% with automation and achieve continuous compliance using USDM’s Cloud Assurance. Read the case study.

Clinical Data Management

Create a compliant GxP/GDPR platform for reliable, consistent data with AWS S3 and AWS Data Lake for life sciences. Read the case study.

Harmonize GxP Systems

Reduce IT overhead by 30%, streamline workflows, boost efficiency, and maintain compliance by harmonizing your GxP systems and quality management processes.

Clinical Data Security

Implement real-time data monitoring to detect and resolve discrepancies using CDMS audit trail analysis. Read the case study.

Rapid GxP System Implementation

Automate GxP and non-GxP workflows to save time, reduce costs, and improve efficiency with ProcessX ITSM solutions from USDM. Read the case study.

GxP-Compliant DevOps

Scale AI chatbot use across clinical sites with GxP compliance built-in to achieve a continuously validated Azure infrastructure. Read the case study.

Life Sciences Clinical Technologies

Life Sciences Clinical Domain Capabilities

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

Clinical System Validation: Ensuring that clinical 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 clinical trial data to ensure accuracy, traceability, and consistency throughout the study lifecycle.
Clinical Workflow Automation: Automating routine clinical workflows to reduce manual effort, minimize errors, and accelerate clinical study timelines.
Risk-Based Monitoring and Quality Management: Implementing risk-based monitoring approaches to proactively address quality issues before they impact clinical trials.
System Integration and Interoperability: Integrating clinical systems with enterprise tools, ensuring seamless data flow, interoperability, and cross-functional collaboration.
Cloud Assurance for Clinical Systems: Providing continuous compliance for cloud-based clinical 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 Clinical Applications: Developing compliant DevOps frameworks for clinical 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 clinical processes aligned with regulatory standards.
Vendor and System Evaluations, Selection, and Management: Evaluating, selecting, and managing clinical 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