Domains
Safety and Pharmacovigilance 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.
Streamline Pharmacovigilance Operations
USDM delivers expert pharmacovigilance solutions that help optimize pharmacovigilance operations, maintain pharmacovigilance data integrity, and scale PV systems. We integrate safety databases, align with global safety compliance regulations, and ensure effective drug safety and pharmacovigilance. Trust USDM for reliable pharmacovigilance services and end-to-end pharmacovigilance system validation.
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. Read the blog.
Compliant Management
Integrate compliant management with CAPA tools to avoid delayed responses and inconsistent resolution quality. Learn more about our solution.
Real-Time Signal Detection
Identify safety signals from large volumes of adverse event data using AI-driven detection tools. Learn more from our white paper.
CAPA Integration
Handle deviations, non-conformances, and audit findings with complete traceability and documentation. Read the case study.
Post-Market Surveillance
Automate safety reporting and manage product recalls after a product is launched on the market. Read the blog.
Global Pharmacovigilance Compliance
Automate and simplify reporting across multiple regions to ensure compliance with global standards. Learn more about our solutions.
Life Sciences Safety Technologies
Pharmacovigilance Capabilities
Save time and money with capabilities offered by USDM, which include:
Inspection-Ready Pharmacovigilance Services for Life Sciences Compliance
- Pharmacovigilance System Validation: Validate systems like CTMS, EDC, and eTMF to meet FDA, EMA, and GCP standards, ensuring end-to-end drug safety and pharmacovigilance compliance.
- Data Integrity and Quality Management: Ensure pharmacovigilance data is accurate, consistent, and traceable throughout the safety lifecycle, supporting confident decision-making and inspection readiness.
- Risk-Based Monitoring and Quality Management: Identify and address safety risks proactively using risk-based approaches that strengthen overall safety and pharmacovigilance oversight.
- Standard Operating Procedure (SOP) Development: Develop and maintain compliant SOPs tailored to evolving global regulatory standards and pharmacovigilance services requirements.
- Cloud Assurance for Clinical Systems: Maintain real-time audit readiness for cloud-hosted PV systems through USDM’s proven Cloud Assurance framework.
- Data Security: Secure patient and trial data across safety platforms with protocols that align to GDPR, HIPAA, and GxP mandates.
- Change Management and User Training: Drive successful implementation and adoption of new PV systems with structured change management and user-centric training programs.
- Vendor and System Evaluations, Selection, and Management: Confidently assess, select, and oversee pharmacovigilance service providers and technologies for optimal performance and regulatory alignment.
Technology-Driven Pharmacovigilance Solutions to Optimize Safety Operations
- Safety Workflow Automation: Streamline routine safety tasks and reporting processes to minimize errors, reduce manual work, and accelerate drug safety timelines.
- System Integration and Interoperability: Connect your safety database and clinical systems with enterprise platforms to enable seamless data exchange and cross-functional collaboration.
- GxP-Compliant DevOps for Clinical Applications: Build and deploy compliant, scalable applications for pharmacovigilance safety services using DevOps frameworks that align with GxP and accelerate innovation.
- eTMF Optimization: Enhance eTMF systems for better documentation control, traceability, and regulatory reporting readiness.
- System Design, Implementation, Validation, and Release Management:
- Safety Database
- Clinical Trial Management System (CTMS)
- Electronic Data Capture (EDC)
- Electronic Trial Master File (eTMF)
- Electronic Patient-Reported Outcomes (ePRO)
- Electronic Document Management System (EDMS)
- Electronic Common Technical Document (eCTD)
- Interactive Response Technologies (IRT/IVRS)
- Clinical Data Warehouses
- Secure Data Server
Tap into PV Data & Safety Databases
USDM’s pharmacovigilance solutions help life sciences organizations harness pharmacovigilance data through validated safety databases. Improve drug safety and pharmacovigilance outcomes with real-time insights, regulatory alignment, and scalable systems that power smarter pharmacovigilance operations and ensure global safety compliance.
More FAQs About Pharmacovigilance Services
Pharmacovigilance refers to the science and activities related to detecting, assessing, and preventing adverse effects of drugs. USDM’s pharmacovigilance solutions support drug safety, data integrity, and global compliance through validated systems and expert safety and pharmacovigilance services.
Pharmacovigilance plays a critical role in protecting patient safety by monitoring, analyzing, and preventing adverse drug reactions. USDM’s pharmacovigilance solutions help ensure drug safety, maintain accurate pharmacovigilance data, and support compliance with evolving global safety and pharmacovigilance regulations.
Companies can prepare for PV inspections by using USDM’s pharmacovigilance solutions to validate systems, ensure safety compliance, maintain accurate pharmacovigilance data, and streamline pharmacovigilance operations aligned with global regulatory expectations.
Outsourcing pharmacovigilance support to trusted pharmacovigilance service providers like USDM ensures expert oversight, scalable operations, validated systems, and efficient drug safety and pharmacovigilance management—while reducing costs and ensuring ongoing safety compliance across global markets.
Global safety and pharmacovigilance regulations vary by region, with differing timelines, formats, and reporting requirements. USDM’s pharmacovigilance solutions help companies navigate this complexity, ensuring consistent drug safety reporting and pharmacovigilance data accuracy across all regulatory jurisdictions.
Tools to manage adverse event data include validated safety databases, signal detection systems, and integrated PV platforms. USDM’s pharmacovigilance solutions streamline tracking, enhance pharmacovigilance data integrity, and support compliant drug safety and pharmacovigilance workflows across global operations.
Targeted training improves pharmacovigilance operations by enhancing team expertise in safety compliance, adverse event reporting, and system usage. USDM’s pharmacovigilance services include customized training to optimize drug safety practices and ensure effective use of validated pharmacovigilance solutions.
We can help you safeguard patient data and product integrity to reduce risks.
