Discovery

Pharmaceutical companies have seen their R&D costs dramatically increase while product productivity has declined. In addition, as many blockbuster drugs have reached patent expiration, there is increasing competition from generic or other branded drug makers.

 

High Performance Research & Development

There is a need for technologies that increase productivity, reduce bottlenecks and deliver more marketable products, at less cost, and in a shorter time than in the current 10 to 15-year sequential drug development timeline.

The right IT solution in a blockbuster drug's R&D phase can catapult a company into a market leadership role.

New IT solutions improve researchers ability to acquire, format, search, and analyze disparate data sources and types. Data mining and visualization software6 are improving scientists' ability to screen data and identify important relationships.

3-D molecular modeling, which studies of the function and relationships between biological molecules, is enabling scientists to conduct some research at the computer instead of at the lab bench, reducing the time and costs of the R&D phase.

Developing a blockbuster drug requires detailed analysis. USDM can help implement these systems at the right cost of ownership.

Now is the time to address R&D cost-constraints and inefficiencies that have accrued over the past decade. USDM has worked with R&D organizations to drive dramatic changes and deliver tangible productivity results in as little as a few months. As industry forces fundamentally re-shape drug discovery performance, a robust and integrated informatics platform offers you competitive advantage.

  • Significant, immediate and sustainable reductions in the Total Cost of Ownership of new and enhanced business processes and IT-enabled capabilities.
  • Improved time to deliver the new capabilities.
  • Increased productivity of capability development and operations teams.

R&D Document Management

Fully compliant electronic document capabilities to support all regulatory documents in the R&D environment. USDM works with clients to provide an end-to-end solution enabling the creation, capture, dissemination and archiving of regulated R&D documentation throughout the lifecycle of the product.

cGMP Compliance

Solutions to manage cGMP related documents and processes in accordance with cGMP guidelines. USDM is able to provide an end-to-end solution across the enterprise including procedures, processes and associated training.

21 CFR Part 11 Compliance

Identification of gaps in 21 CFR Part 11 compliance and the development of a pragmatic, actionable implementation program. Action plans focus on reducing the cost and complexity of Part 11 compliance and the development of sustainable long-term compliance capabilities.

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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