The Case for a Clinical Data Strategy

Part One

Roadmap to Digital Transformation Series

In today’s environment, more data than ever is being created from an expanding set of sources spanning from wearables to genomics. Many life sciences companies are looking for ways to transform their approach to become data driven organizations with Digital Health initiatives. This makes the challenge of maximizing value from data even more critical. To do so requires an organizational approach and vision around data strategy.

• Meeting the demands of clinical trials requires data with sufficient breadth, quantity, quality, timeliness, and accessibility.
• Preparing to meet these demands is best accomplished by establishing a data strategy.
  • Complementary analytics and standards strategies are required for a successful data strategy implementation.
  • Automation is a prerequisite to sufficiently meet the data demands for supporting clinical trials.
• A data strategy focuses on what data is needed and how it should be presented to the data consumers; a digital strategy focuses on the tools and techniques to achieve the data strategy goals.
• To meet the needs of individual business units, each unit should independently define their unit’s data strategy.
• Clinical data requires a strong defensive data strategy as foundation as well as a complementary analytics and standards strategy. Environmental drivers are pushing towards adoption of more offensive capabilities as well.

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