Harnessing the Power of Clinical Data
Standardization helps improve operational productivity, makes data sharing seamless internally and externally, ensures cross-functional consistency, and enables organizations to effectively leverage big data.
Life sciences companies are rich in data and gaining exponentially more clinical data all the time. New scientific breakthroughs, the growth in research partnerships and digitization that brings new insights and new ways of gathering information — all feed the data expansion. This trend, along with the need to improve the review process and safeguard patients, has led to the development of the Clinical Data Interchange Standards Consortium (CDISC) open data standards.
Standardization can improve the quality of medical research by making it simpler to transmit and share complex data, minimizing resource-intensive programming, and making the data submitted to regulatory authorities consistent. Data inconsistency remains a huge challenge for companies, resulting in numerous questions from reviewers, who must clarify submissions and ensure that products on the market are proven safe and effective.
For some years, regulatory authorities have urged companies to use data standards in their submissions. Then, in December 2014, the U.S. Food and Drug Administration (FDA) published binding guidance on study data standards, making the CDISC standards mandatory as of December 17, 2016.
While organizations must make responding to these mandates a priority, they must also understand the broader business value of standardization. Standardization helps improve operational productivity, makes data sharing seamless internally and externally, ensures cross-functional consistency, and enables organizations to effectively leverage big data.
This paper looks at biometrics – turning data into clinical insights – and the benefits of being CDISC- proficient.