Life Sciences Domain Expertise

Nonclinical Development

Adopting Model Based Drug Development

The Situation: The discovery medicine organization of a global pharmaceutical company sought to change their current working practices to embrace a model based drug development (MBDD) paradigm that would encourage quantitative data analysis and use of that analysis to provide support for early go/no-go decisions and future trial design. The organization was functionally siloed both in terms of business process and data integration. In order to achieve the necessary paradigm shift the organization recognized that change would be required across many fronts including changes in mindset and culture, changes to organizational structure and business processes, as well as the development of technical tools and infrastructure to better support access to and analysis of disparate data.

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BioDevelopment Scientific Systems Assessment

The Situation: The Biologics Development organization within a global pharmaceutical company was challenged to significantly increase their development of new biological entities. To meet the established goals, the business and IT organizations sought a deeper understanding of the company’s current work practices, barriers to efficient operations and evolving business needs. The IT organization aspired to provide industry leading capabilities for the business but their position versus industry peers was unclear. The business and IT organizations needed a shared vision for achieving their goals along with a multiyear strategic roadmap for achieving that vision.

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Cross-Functional Information Transaction Mapping for Drug Development

The Situation: The BioPharma division of a global pharmaceutical company had developed and streamlined functional areas of drug development over many years and the general sense was that the primary business processes and information management was serving the business reasonably well. The larger challenge was in the secondary uses of data across white spaces of the business. Those crossfunctional consumers of information would typically be forced to aggregate and interpret data originally produced for different purposes when that information was needed downstream in the product development lifecycle.

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Pharmaceutical Sciences Data Management Strategy Roadmap

The Situation: Like many large pharmaceutical companies, this client had implemented numerous information management systems in development without a higher level data management strategy. They expressed concerns about redundant storage of data, gaps in the data across systems, and challenges in accessing systems and data consistently. Moreover, there was no ability to search across systems to pull together a comprehensive view of completed work.

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Pharmaceutical Development Data Quality Assessment

The Situation: In the course of contemplating a knowledge management IT strategy for pharmaceutical development, a global pharmaceutical company wondered about the quality of its underlying data. Many of its systems had been implemented independently over numerous years and integration would be one key to the knowledge strategy. Mergers and acquisitions resulted in consolidation of data from many different sources. Data standards and governance applied to the systems was limited. Although the business was confident about its data quality, the system owners and IT expressed concern based on several proof-of-concept knowledge projects they had recently undertaken. They agreed that a data quality assessment might highlight systems and data issues that would need to be addressed before moving forward with more extensive knowledge management investments.

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BioPharm Strategy Roadmap

The Situation: The BioPharm Formulation Development group of a global biopharmaceutical company had a goal of doubling their productivity over the ensuing two years. It was recognized that improving the flow and availability of information and knowledge was a key area for improvement and needed to support the goal of a Quality by Design (QbD) vision. The business needed to examine its information flow, identify gaps and opportunities, and prioritize its business needs. Business needs could then be aligned with the IT strategy to ensure that projects delivering the most business benefit were given suitable priority. Likewise, the IT strategy for knowledge management would be aligned with the business vision. The client invested in an organized approach to assess the information flow in the organization, to determine the knowledge that is managed at key stages in the workflow, and to create a roadmap toward better management of that information and knowledge across the group.

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“What I really appreciated from ResultWorks was the broad perspective that they brought to the table that gave us a better sense of how technical strategies can be devised and how we look at and organize them.”

Director BioPharm Technologies

“This was exactly what the business needed. We have several other areas that could also use this same type of analysis”

Director of Data Services