Science and DNA

eBook: Data Integrity – The Foundation of Good Science

Good Data Alone is Not Good Enough

By: Sandra K. Rodriguez, Market Analyst and Ellyn McMullin, Research Associate

Healthcare is shifting to a Value Based model focused on improving the quality of patient outcomes, enhancing patient-centered care and adopting initiatives that control costs.  The transition to Value Based Healthcare hinges on the availability of unbiased quality and outcomes data. Furthermore, the integrity of these decisions depends upon the accurate and objective analysis of these data to support patient care decisions.

ALCOA - Axendia 2019 - originalFDA has defined data integrity as the completeness, consistency and accuracy of data.  Complete, consistent and accurate data have the following attributes using the acronym ALCOA:

Attributable

Legible

Contemporaneously recorded

Original or a true copy

Accurate

Sound data is the foundation to good decisions and good science.  In the Life-Science industry, patient outcomes, product quality, safety and efficacy all rely upon vast amounts of data that is generated throughout the product lifecycle.  This means that patients and the equity and reputations of brand owners have the potential to suffer greatly without a strong data integrity foundation.

Register to receive our eBook and discover:

  • What is Data Integrity?
  • Why Data By Itself is Not Enough
  • How Data Integrity Enables Good Decision Making
  • Who is Responsible for Data Integrity
  • Quality Metrics Reporting Requirements
  • Why You Should Focus on Data Integrity
  • The Components of an Optimal Solution

Is your company doing good science?  Without data integrity, the results of that science can be in question.

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