Total Regulatory Solution – a “complete” offering from CSC – Webinar 1

The other day I received an invitation from CSC to attend a series of three webinars on their “Total Regulatory Solution” offering.

The “Total Regulatory Solution” consists of three “components”:

  • Software
  • As a service offering
  • Business Process Outsourcing.

Having described CSC’s plans for this earlier (In Part 1, and Part 2 of the FirstDoc User Group posts), I was curious to see what CSC would cover.

Webinar 1

The first webinar was entitled “Flicking the Switch: Integration Drives Greater Regulatory Efficiency” and was presented by Jennifer Webstrom. 

Here are some key points from the webinar:

  • CSC’s was primarily driven by technology (that is – what is required to make sure that their products would run on the latest, and upcoming, technology platforms).
    Approximately 18 months ago they decided to change to focus more on how they can solve business problems that their customers were having.
  • They want to be the go-to company for regulatory submissions.
    Or, to quote their mission statement, they want to…

Provide end to end business solutions for processes involving the creation, review, approval, consumption & exchange of regulated and mission critical documents and content within a Life Sciences organization

  • With the recent acquisition of ISI, CSC offer tools that allow for end-to-end regulatory information management process. These include:
    • Tracker  
    • Assembly Planner
    • FirstDoc or FirstPoint
    • eCDTXPress
    • Publisher
    • Viewer
  • These applications are, currently, disparate applications, but CSC are working to integrate these tools so that they share a common data model, have the same interface, and (ultimately) will be “aware” of the other tools, in the sense that operations in one tool trigger certain “pre-emptive” actions in the other tools.
  • The integration roadmap includes the following:
    • ensure that Publisher, eCDTXpress, FirstDoc, and Viewer work together
    • release of Tracker – integrated with Viewer
    • release of Assembly Planner – integrated with Tracker

Strategy Analysis

This had to happen. Providing an application, or a collection applications, that allow users to perform specific tasks is one thing, but to have a truly integrated suite of tools that can work together, is another. Users do not want to have to “think” about what they are doing. They just want to be able to complete a task, in the most efficient way they can, without having to consider the different interfaces that they need to work with, or the different processes that they have to follow for each application they use.

By changing their focus from one of technology to one that is more on the business challenges that pharmaceuticals companies face, means that CSC can streamline the whole regulatory submission process so that there is as little “pain” as possible.

And, naturally, if they can achieve this, they do help to position themselves in the market as the “one-stop shop” that they want to be.

The other webinars

As mentioned above, there are three webinars in which CSC are describing their new “Total Regulatory Solution”. The other webinars are:

  • Data in the Sky: Finding Flexible Solutions in the Cloud
  • Clearing the Path to Innovation: Exploring Total Regulatory Outsourcing

I plan to write posts on these as well.

Reference sites

  • CSC’s Life Sciences: CSC Total Regulatory Solution Webinar Series
  • Webinar 1 – download site

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