Domain

Safety in Life Sciences

Ensure that pharmacovigilance, drug, and medical device products are safe for use by patients and comply with global regulatory standards throughout the product lifecycle.

Automating workflows, minimizing risk, and enhancing pharmacovigilance across the product lifecycle ensures patient safety. We can help!

Data Integration

Integrate pharmacovigilance systems with other enterprise systems, such as ERP and QMS, to ensure real-time access to safety data and comprehensive oversight. Improve decision-making with integrated, consistent data visibility.

Interoperability

Enable seamless integration of safety data across multiple systems to ensure real-time access, comprehensive safety oversight, and accurate reporting. Ensure data flow consistency across systems for efficient regulatory compliance and safety management.

End-to-End Managed Services

Provide continuous monitoring of pharmacovigilance systems, maintain compliance with global regulations, and ensure ongoing validation throughout the entire product lifecycle. Support product safety and risk management from pre-market to post-market phases.

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

Life Sciences Safety Use Cases

Adverse Event Reporting Automation

Automate adverse event reporting to manage multiple reporting formats and reduce manual data entry errors.

Complaint Management

Integrate compliant management with CAPA tools to avoid delayed responses and inconsistent resolution quality.

Real-Time Signal Detection

Identify safety signals from large volumes of adverse event data using AI-driven detection tools.

CAPA Integration

Handle deviations, non-conformances, and audit findings with complete traceability and documentation.

Post-Market Surveillance

Automate safety reporting and manage product recalls after a product is launched on the market.

Global Pharmacovigilance Compliance

Automate and simplify reporting across multiple regions to ensure compliance with global standards.

Life Sciences Clinical Technologies

Life Sciences Clinical Domain Capabilities

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

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