Overview

As life science organizations grow, so does the need for data governance. There is a requirement in this industry to ensure patient safety, and that entails a focus on the quality of products and compliance, which necessitates exceptional data quality. The challenge becomes how to best leverage people, process, and technology to gain control.

“Every year, poor data quality costs organizations an average $12.9 million. Apart from the immediate impact on revenue, over the long term, poor quality data increases the complexity of data ecosystems and leads to poor decision making,” according to a Gartner report released in July of 2021.

The solution to eliminating data-driven mistakes, is a robust data governance program. Simple to grasp but, challenging to implement. For many organizations, achieving Data Governance requires aligning the cross-functional stakeholders along with organizing and optimizing systems and processes, or as our client states in this case study, ”herding the cats and pulling the spaghetti apart, and bringing in the building blocks needed.”

This case study illustrates how a biotech company leveraged Astrix expertise at creating alignment and implementing an effective framework for data governance to achieve critical—and sustainable success.

Our biotech client’s expansion in global development initiatives increased many fold over a previous five-year period. For a long time, systems were implemented somewhat ad hoc to solve problems of the day. However, as the business accelerated a growing amount of human capital was needed to tackle the increasing volume of studies and submissions.

This required diligent attention to numerous manual processes tracked by a plethora of spreadsheets, word of mouth communications, data movement via spreadsheets, data re-entry, etc.

Growth of operations drove the need to consider more effective means of managing increases in development studies and submissions, as well as all the supporting activities, including data management.

A key growth inhibitor, the leadership team recognized, was the absence of consistent data management and governance. This recognition fueled a top-down commitment to launch a data governance program focused on enabling the organization to manage data as a critical asset.

How Astrix enabled success

The company engaged Astrix to both:

• Conduct assessments of several key global development functions, and
• Construct a framework specifically designed to support data governance needs across the entire

To facilitate the buy-in essential to enterprise-wide acceptance and adoption, the project team was composed of professionals from across the organization. The expectation was communicated that, over time, all functions would be represented to participate in tailoring the framework’s design to address their business needs.

Initial activities focused on both understanding the leadership team’s business imperatives and utilizing them to develop the project’s guiding principles. In parallel, Astrix developed a draft data governance policy (that would later be underwritten and authorized by the leadership team to characterize the importance of data governance and formally establish the mandate for the activities and technology to support it).

An assessment of the identified functional areas served to both surface and socialize the issues hampering the organization’s effectiveness with managing and using data. While some of these issues were identified as impacting a particular function, many affected the entire development organization.

A draft data governance framework was designed that was tailored to the organization and covered data governance constructs regarding people, process, and technologies. As part of the framework, data governance roles, responsibilities, and interactions were defined. Processes with specific use cases were created for developing and managing business glossaries; identifying and managing master data, metadata, reference standards; and assessing impacts to upstream and downstream business areas. In addition, technology needs were evaluated for managing all types of data, cataloging data, etc.

Once the team was aligned with the framework, plans were defined to tackle short-term challenges (i.e., what we can do now for positive impact) and identify long-term investments (e.g., what technologies we can introduce that will make it progressively easier to implement and govern data).

The client realized these key benefits from the engagement:

• Solidified a common understanding among cross-functional stakeholders regarding the current state of the data governance landscape and associated challenges.
• Developed a data governance policy that outlines the strategic directive for treating data as a corporate asset.
• Created a data governance framework to address functional needs and then extended across business functions.
• Aligned on approach and secured buy-in from sponsors and stakeholders to execute the data governance strategy.