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How Clinical Architecture Can Help You Meet Corporate Goals

By  Chris McSpiritt Chris McSpiritt  on 2015-10-19 10:00:00  |  Featured in  Life Sciences , Clinical Architecture , strategy , clinical
Chris McSpiritt
Posted By Chris McSpiritt
in Life Sciences in Clinical Architecture in strategy in clinical
on 2015-10-19 10:00:00

clinical architectureEvery life sciences company (Sponsor and CRO) is under incredible pressure to help get drugs to market quicker and in a more compliant manner. This too often leads to companies making siloed and tactical decisions around eClinical system selection and implementation. Sometimes these choices work out in the long-term but too often they result in investments that do not deliver sufficient return on investment (ROI). We have discovered working with clients that taking a step back to take a holistic view of where a company is, and where it needs to be, provides value in both the short- and long-terms.

One way to take a strategic step backward is to initiate a clinical architecture project. A clinical architecture project has three main phases:

  • Strategy Identification and Required Capability Identification
    In the strategy Identification and Required Capability Identification phase clients work to define what their corporate goals/objectives are and what must occur to meet goals. The goals and objectives span the gamut from increasing efficiency of internal operations to improving inspection readiness to being better at performing oversight of CRO partners. It is important to gain consensus on the strategy as all subsequent phases and decisions are lensed against the corporate/departmental strategy. Once the strategy has been defined the team needs to understand what capabilities are needed to support the strategy. Paragon has a best practice inventory of R&D capabilities that we bring to bear in support of client initiatives. We leverage this inventory and map strategy components to the supporting capabilities. This mapping serves as the basis for the solution evaluation processes.
  • Current State Evaluation and Gap Analysis
    In the strategy Identification and Required Capability Identification phase clients work to define what their corporate goals/objectives are and what must occur to meet goals. The goals and objectives span the gamut from increasing efficiency of internal operations to improving inspection readiness to improving performing oversight of CRO partners. It is important to gain consensus on the strategy as all subsequent phases and decisions are lensed against the corporate/departmental strategy. Once the strategy has been defined the team needs to understand what capabilities are needed to support the strategy. Paragon has a best practice inventory of R&D capabilities that we bring to bear in support of client initiatives. We leverage this inventory and map strategy components to the supporting capabilities. This mapping serves as the basis for the solution evaluation processes.
  • Future State Visioning and Roadmap Development
    During this phase, we prioritize the filling of any capability gaps by analyzing which gaps are required to support the goals of the organization. We also identify potential solutions to filling those gaps to provide a jump-start for clients on moving forward. Our clients have used this prioritized roadmap to directly influence their IT and R&D planning cycles and provide their overall framework for long-term solution lifecycle management.

Common Findings

As we have conducted clinical architecture projects we have observed a few common themes:

  1. Organizations don’t have a quantifiable strategy that influences eClinical solution selection/implementation and thus invest in what is trending and not necessarily what is needed for their unique strategy
  2. Organizations often invest in redundant capabilities without knowing (one company had procured three tools that all support external collaboration but only used a small subset of functionality within each tool)
  3. Data availability is a key theme as Sponsors want better access to a holistic view of their studies and CROs need an ability to provide this in a unified manner to their clients

How Paragon can help

Due to our experience helping clients (Sponsors and CROs) define strategy and implement point solutions (eTMF, Clinical/Investigator Portals, ECM, CTMS, etc) we have deep insight into how organizations operate and what their pain points are. We have used this knowledge to define best practice capability maps, value streams, and eClinical system architectures. We leverage these accelerators to help your team quickly define and understand what needs to be done in terms or process and system implementations.

If you need help defining your strategy and determining what solutions you need to invest in, request a complimentary consultation with one of Paragon’s Clinical Architecture subject matter experts to discuss options that fit your organization's unique challenges and goals.

 

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Chris McSpiritt

Chris McSpiritt

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Chris McSpiritt is the Clinical Practice Lead for Paragon’s Life Science Research& Development team. Chris has over 10 years of pharmaceutical industry experience in R&D and has applied his business architecture, business process management, and analytical skills to help pharmaceutical companies improve the conduct of clinical trials for global life sciences companies. Chris holds a BA in Psychology from the University of Notre Dame. He is an active member of the Business Architecture Guild, Association of Business Process Management Professionals, Project Management Institute, and Drug Information Association.

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