Domain

Commercial Strategy and Operation in Life Sciences

Drive product commercialization, including market access, sales and marketing, pricing strategies, distribution, and post-market surveillance.

Empower your commercial strategy with data-driven insights, streamlined workflows, and regulatory compliance to accelerate product commercialization.

Product Commercialization

To ensure ongoing compliance and effectiveness, focus on the comprehensive strategy and operations that drive successful product commercialization, including market access, sales and marketing efforts, pricing strategies, efficient distribution channels, and continuous post-market surveillance.

Product Compliance

Establish systems that ensure real-time compliance with global regulatory standards by implementing robust post-market surveillance mechanisms, actively monitoring product performance, safety metrics, and effectiveness to maintain high standards and meet evolving regulatory requirements.

Product Launches

Effectively manage and scale product launches by leveraging quality management, ensuring data integrity, implementing robust data strategy and governance, automating critical processes, and establishing post-market surveillance, ensuring seamless compliance and optimal product performance.

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

Commercial Use Cases

Market Access & Reimbursement

Use real-world evidence to develop strategies that maximize market access and revenue potential.

Customer Engagement

Streamline engagement, optimize sales performance, and provide real-time visibility into sales activities.

Post-Market Surveillance

Deploy ongoing product monitoring for safety and effectiveness; USDM ensures continuous compliance.

Data-Driven Insights & Analytics

Enable insights into product performance, market demand, and customer engagement using real-time data.

Pricing Strategy

Balance product value with market demand; USDM ensures pricing strategies align with regulatory requirements.

Global Market Expansion & Localization

Ensure that product documentation, labeling, and marketing materials comply with local regulations.

Life Sciences Clinical Technologies

Life Sciences Clinical Domain Capabilities

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

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