Data governance

Data Governance Biotech Company moves from clutter to alignment with a common framework

As life sciences organizations grow, so does the need for data governance. There is a requirement in this industry to ensure patient safety, and this involves focusing on product quality and compliance, which requires exceptional data quality. The challenge is how to get the most out of people, process and technology to gain control.

Every year, poor data quality costs businesses an average of $12.9 million. Besides the immediate impact on revenue, in the long term, poor quality data increases the complexity of data ecosystems and leads to poor decision making.according to a Gartner report published in July 2021.

The solution to eliminating data-related errors is a robust data governance program. Simple to grasp but difficult to implement. For many organizations, achieving data governance requires aligning cross-functional stakeholders while organizing and optimizing systems and processes, or, as our client in this case study puts it, “bringing cats together.” and separate the spaghetti, and bring the necessary basics.”

This case study illustrates how a biotechnology company leveraged the expertise of ResultWorks to create alignment and implement an effective data governance framework to achieve critical and sustainable success.

BUSINESS CHALLENGE

Our biotechnology client’s expansion into global development initiatives has grown many times over in the previous five years. For a long time, systems were put in place somewhat piecemeal to solve the problems of the day. However, as the business accelerated, an increasing amount of human capital was needed to cope with the growing volume of studies and submissions.

This required careful attention to many manual processes followed by a plethora of spreadsheets, word of mouth communications, movement of data through spreadsheets, re-keying of data, etc.

The growth in operations has resulted in the need to consider more efficient ways to manage the increase in development studies and submissions, as well as all support activities, including data management.

The management team recognized that a key inhibitor of growth was the lack of consistent data management and governance. This recognition fueled a top-down commitment to launch a data governance program aimed at enabling the organization to manage data as a critical asset.

HOW RESULTWORKS ENABLED SUCCESS

The company engaged ResultWorks to:

  • Conduct assessments of several key global development functions, and
  • Build a purpose-built framework to meet data governance needs across the entire organization.

To facilitate the buy-in essential for enterprise-wide acceptance and adoption, the project team was comprised of professionals from across the organization. The expectation was communicated that over time, all functions would be represented to participate in adapting the design of the framework to meet their operational needs.

Initial activities focused on both understanding the management team’s business imperatives and using them to develop the project’s guiding principles. In parallel, ResultWorks has developed a draft Data Governance Policy (which will then be endorsed and authorized by the leadership team to characterize the importance of data governance and formally establish the business and technology mandate for the sustain).

An assessment of the identified functional areas served to both highlight and socialize issues that impede the organization’s effectiveness in 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 has been designed, tailored to the organization and covering data governance concepts around people, process and technology. As part of the framework, data governance roles, responsibilities and interactions have been defined. Processes with specific use cases have been created to develop and manage business glossaries; identify and manage reference data, metadata, reference standards; and assess impacts on upstream and downstream industries. In addition, technological needs were assessed to manage all types of data, catalog data, etc.

Once the team was aligned with the framework, plans were made to address short-term challenges (ie. what we can do now for a positive impact) and identify long-term investments (for example, what technologies we can introduce that will gradually facilitate data implementation and governance).

THE IMPACT OF RESULTWORKS – KEY BENEFITS

The client realized these key benefits of the engagement:

  • Consolidation of a common understanding among cross-functional stakeholders regarding the current state of the data governance landscape and associated challenges.
  • Development of a data governance policy that outlines the strategic directive to treat data as a business asset.
  • Created a data governance framework to meet functional needs, then extended to all business functions.
  • Alignment to the approach and secure buy-in from sponsors and stakeholders to execute the data governance strategy.

“I couldn’t have asked for things to go better. You’ve all been professional, putting the cats together, separating the spaghetti, and getting us the building blocks we need. All the pieces are there. “
Director, Data Governance and Standards

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