According to a GlobalData survey last year, over 70% of pharma industry respondents stated they expect that drug development will be the area most impacted by the implementation of smart technologies.  With that being the case, it is imperative that Life Science organizations understand the technologies and concepts that are emerging and how they can enhance the Clinical Development area. Having an understanding of the technology trends, and then developing a strategy to take advantage of those trends, is critical to success.

Why a Platform Architecture is Required in Clinical Development

Many Clinical Development organizations currently have non-integrated solutions and redundancies with multiple systems performing the same function. This causes many challenges including compliance risks and inefficiencies. A more thoughtful approach is to move from this situation to a more rationalized Platform environment focused on business value.

A platform approach requires thinking differently. It involves incorporating a suite of modules, applications, components, and services, that are used together to deliver multiple complex business processes. These are not typically from a single vendor, but rather an assembling of the best rationalized set of tools to deliver business capabilities that can be managed in a coordinated and cohesive way. For example, if we look at content and document management capabilities, there are typically many different flavors across an organization. These various applications may be meeting slightly different needs, however, those could be managed as a platform service. We can rationalize these tools to offer standard services and reusable components.

Data Centricity and Why it Matters

Another area that needs to be addressed is data centricity and how a platform approach fits with this concept.

With a data centric model we leverage an architecture where data is the primary and permanent asset, and applications come and go. In the data centric architecture, the data model precedes the implementation of any given application and will be valid long after the application is gone.

The benefit of this model include:

• Data are not ‘locked’ in disparate and complex commercial applications (data outlives applications)
• Data are readily findable, accessible, interoperable and reusable (FAIR)
• Reduces the complexity of application integration, much of which currently stems from lack of data interoperability
• Facilitates the ease and flexibility of rapid application development, workflows, and analytics exploration such as:
  • Easier to change applications
  • Eliminates data migrations when changing application
• Independence of data from applications and the evergreening of the data.

However, the reality is that it’s not that easy to realize this type of data environment in practice. Typically, the organization has many commercial applications, and they have their own data models, metadata, and controlled vocabulary with application code tide to those models. This complicates matters in that commercial applications are not designed to work with a common data model, and that paradigm isn’t changing.

We therefore need a way to get closer to that Data Centric Model. To do this we can implement a logical managed data hub approach. A logical data hub’s purpose is to unify data and conform data products, establish master and reference data, and manage the controlled vocabulary. Application platforms then to be publishers and subscribers to that data hub by reading the master and reference data and retrieving conformed data from that hub. The application platforms perform their functions by transforming and enriching the data, and then publishing that data back to the hub where it can be unified with the other datasets from other sources.

The logical data hub is centered around a common semantic data model which is extensible and facilitates business content search and navigation. The platform approach and the logical data hub architecture get us closer to our goal of data centricity.

Summary

Many Clinical Development organizations currently have non-integrated solutions and redundant systems that serve the same purpose. This creates many issues, including a lack of compliance and inefficiency related to how data is captured, managed and accessed. Moving from this circumstance to a more rationalized platform environment focused on business value is a more modern, effective approach.

Technology can be better leveraged to improve the outcomes of clinical development by employing  a platform based architecture along with a data centric model. This makes organizations less dependent on commercial applications while prioritizing the key asset of clinical development – the data.

Why It Matters To You

Understanding the technology trends that impact the Clinical Development of the Life Sciences organization and then developing a strategy to take advantage of them is imperative to ensure compliance and efficiency.

In this blog we discussed:

• Why a platform based and data centric approach is imperative for Clinical Development
• What a platform architecture is and how it impacts Clinical Development.
• How a data centric model works and the benefits it provides

ResultWorks – An Astrix Business

About Astrix

For over 25 years, Astrix has been a market-leader in delivering innovative solutions through world class people, process, and technology that fundamentally improves scientific outcomes and quality of life everywhere. Founded by scientists to solve the unique challenges life sciences and other science-based business face, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations. ResultWorks, an Astrix business, achieves success for our clients through skilled facilitation and exceptional management leadership across Life Science domains from Research, Non-Clinical & Clinical Development, Regulatory Affairs, to Safety, Manufacturing, and Pharmacovigilance. To learn more about how ResultWorks enables biopharmaceutical leaders’ success, visit www.resultworksllc.com.

To learn the latest about how Astrix is transforming the way science-based business succeed today, visit www.astrixinc.com.