Connecting people, machines, and data in new ways for real-time insights to improve business outcomes

We live in a time when life sciences companies large and small are attempting to transform themselves with unprecedented new and emerging technologies in every part of the globe. Organizations are striving to create more value than ever before for customers, employees, shareholders, and society at large.  Digital technologies like Cloud Computing, Platform-as-a-Service, Purpose Built Applications, Mobile Platform, and Artificial Intelligence are helping reimagine modern enterprises to drive high-impact business outcomes at a lower cost. 

Our Digital Transformation team combines business strategy, domain expertise, and new technology to develop innovative strategies in product, services, markets, and business models. We then translate these strategies into specific initiatives and projects that allow your enterprise to deploy data, applications, technology, and capabilities through value-driven roadmaps that drive successful execution.  

USDM can help you with: 

DIGITAL TRANSFORMATION STRATEGY AND ROADMAP 

• Strategy – The foundational element of any digital transformation journey is to identify a set of business initiatives and drivers that benefit from new strategic opportunities afforded by cloud and emerging technologies. The emphasis must be using technology to transform businesses rather than just adding bells and whistles to existing processes. Digital affects your core business, opens new possibilities, and requires a foundational change to drive desired results. At USDM, we combine business strategy, life sciences domain expertise and new technology to help accelerate our customer's digital transformation journey and achieve cost-effective, high-impact business outcomes. 

• Roadmap – We help build your value-driven roadmap broken down by initiatives and projects that allow your enterprise to deploy data, applications, technology, and capabilities. 

• Change Management – As change management experts, we offer services to implement strategies for accomplishing change, controlling change, and helping people to adapt to change (OCM).  

• Program Management – We also offer structured program management services to improve your organization’s performance in delivering business outcomes. 

IMPLEMENTATION SERVICES 

We work with several, best in class, digital transformation partners, and jointly develop solutions that meet the ever-evolving quality, compliance, and regulatory demands of the life sciences industry.   

ComplianceQuest provides a suite of Enterprise Quality Management System (EQMS) applications to significantly improve culture, collaboration, performance, and innovation by driving digital transformation via the Salesforce platform. Implementation services includes: 

• Document Management  
• Training Management 
• ​Change Management 
• Non-Conformance/Deviation Management 
• CAPA Management 
• Complaints Management 
• Incident Management 
• Inspection Management 
• Supplier Management 
• Risk Management 
• Audit Management 
• ​Equipment Management 

 

Salesforce provides the leading CRM solution with a suite of GxP applications that offer unmatched configurability. You can easily extend Salesforce to GxP areas like clinical, quality, and other regulated areas. Implementation services include:

• Regulatory Information Management System (RIMS) 
• Product Registration Management (Planning Roadmap, Notification of change, etc.)
• Workflow-as-a-service to add new business use cases with compliance built-in

Box provides powerful content management with custom integrations and scalable delivery through a complaint-ready content management system. Implementation service includes: 

• System configuration through the administrative console 
• Initial validation and on-going, continuous cloud compliance through USDM Cloud Assurance 
• Integration with other cloud applications 
• ​Box consulting 

DocuSign provides an excellent solution for customers to enhance workflows by adding electronic signature and digital signature capabilities, including Part 11 compliant e-signature solutions that bolt onto a myriad of other GxP applications. Implementation services include: 
 

• System configuration through the administrative console 
• Initial validation and on-going, continuous cloud compliance through USDM Cloud Assurance 
• ​Integration with other Cloud Applications 

 

DATA AND ANALYTICS 

Data Management 

• Data Governance 
• Master Data Management & Data Quality 
• Big Data & Data Lakes 

Data Science and Analytics  

• Machine Learning & Advanced Analytics 
• Automation & Optimization 
• Visualizations & Dashboards 
• Microservices & DevOps 

Artificial Intelligence 

• Machine Learning (ML) / Deep Learning (DL) 
• Explainable AI 
• Natural Language Processing (NLP) 
• Robotic Process Automation (RPA) 

 

USDM QUALITY CLOUD – POWERED BY CQ 

We offer a suite of pre-configured quality management solutions designed to drive the digital transformation of quality and compliance for life sciences customers. 

• Fast-track: Fully configured document management solutions based on industry best practices 
• 100% Native Cloud: Built on world-class Salesforce platform and powered by ComplianceQuest Enterprise Quality and Compliance Management Systems 
• Industry Best Practices: Built-in best practices and inclusive of all required documentation to accelerate the deployment and adoption of the system 
• Customizable: Provides flexibility and configurability to meet additional customer-specific requirements 
• Future-proof: Designed for the continually changing regulatory environment and scaled to grow with your enterprise