Information Technology (IT) is the critical backbone of any life sciences company and a necessity for collecting, archiving, and analyzing complex data.

With a variety of hardware, software, and database technologies on the market, compatibility is key. USDM Life Sciences offers expert assessments and technology roadmaps to identify your organization’s critical needs. 
 
USDM helps build your value-driven roadmap with initiatives and projects that allow your enterprise to deploy data, applications, technology, and capabilities. We start by assessing your business needs and your documented and informal processes and procedures. Then we identify critical systems needed and document the business requirements. Next, we will work together to prioritize systems, develop timelines for implementation, and guide you through your vendor selection.
 
USDM can help you to:

  • Develop a strategy
  • Align investment
  • Establish governance
  • Optimize execution

Watch our on-demand webinar, IT Systems for  Emerging Life Sciences - From R&D to Commercial, for more information.

Building a Compliant IT Roadmap

When it comes to building a compliant IT roadmap, USDM has the knowledge and experience to get you started. We will:

  • Identify specific business imperatives and opportunities for IT investments
  • Align IT investments with key milestones, regulatory applications, commercial launch, etc.
  • Select IT platforms and solutions to support your business objectives
  • Prioritize implementation
  • Provide budget estimates and resource requirements  

Additionally, USDM will help ensure your organization is aligned to the IT Roadmap by assessing and recommending skills and capabilities requirements,  headcount, and budgets to ensure success.

Unique IT Roadmaps for Unique Life Sciences Needs

Whether you are a pre-commercial emerging company or a global pharma company integrating multiple companies amid M&A events, USDM can address your unique needs. We know that no two companies are alike, and your talent, maturity, existing technology, and business strategy are nuanced to only your needs.
 
From your G&A systems, to lab, clinical, quality, manufacturing and many other GxP systems, we know the technology and we know how to optimize it. With decades executing life sciences best practice business processes and a large network of technology partners, we have the experience with the requirements and the systems to future-proof your strategy. 

Life Sciences Technology Expertise:

  • Building Management Systems
  • Clinical Systems (CDMS, CTMS, EDC, eTMF, ePRO, IRT)
  • Content Management Systems 
  • Enterprise Resource Planning (ERP)
  • Equipment Qualification
  • e-Signature 
  • Freezer Systems
  • Laboratory Systems (ELN, Freezer Management, LIMS)
  • Manufacturing Systems (ERP, PLM)
  • Quality Systems (LMS, Quality Document Management, QMS)
  • Regulatory Publishing
  • Safety Systems and Signal Detection
  • Submissions
  • UDI & Serialization
  • and many more

Select Technology Partners:

Contact USDM to start discussing your strategic IT roadmap today.

Learn More About Compliance Strategies

Webinar: Your IT Roadmap - Guidance for Early-Stage Life Sciences Startups
Blog: 5 Tips to Drive Your IT and Compliance Strategy 
Blog: SOPs 101 – A Best Practice Approach for Emerging Life Sciences Companies
White Paper: Computer Software Assurance: What You Need to Know About FDA's Upcoming Guidance

 

Thought Leaders

Leading experts in every Life Sciences field.

Learn More
Bob Lucchesi
Bob Lucchesi

Vice President of Global Regulatory Compliance, Quality Assurance and Auditing

Jay Crowley
Jay Crowley

Vice President of Medical Device Solutions and Services

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