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Clinical Data Standards Survey Report: The FDA’s Regulatory Clock Is Ticking

Pharmaceutical firms must meet FDA mandates by December 2016. How Accenture’s Clinical Data Standards Capability Maturity Model can help.

Overview

Pharmaceutical companies are focused on implementing CDISC (Clinical Data Interchange Standards Consortium) standards primarily to ensure compliance with FDA binding guidance that goes into effect December 2016 and similar international standards under consideration.

Spurred by the FDA deadline and actions by the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Device Agency (PMDA), companies are focused on how they can overcome barriers and expedite adoption of data standards. It was this reality that led Accenture to undertake a survey of executives at life sciences organizations to assess various dimensions of data standards implementation.




We asked these executives about:
Adoption of data standards including benefits and barriersAdoption of data standards including benefits and barriers
Challenges of metadata management including governance and infrastructureChallenges of metadata management including governance and infrastructure
Utility of a data standards capability and maturity modelUtility of a data standards capability and maturity model

Demographics

The survey of 77 executives in the US and Europe was completed in 2015. Respondents represented pharmaceutical, biotech and medical device manufacturers, as well as academic medical centers and clinical research organizations.




Key Findings

Key Findings

The survey results clearly reveal that companies are at different stages in their data standardization journey.




Challenges

Challenges




Utility

Utility

Previously no objective model has been available to gauge progress in adopting standards.
What are the stages?
What are the stages?


What will it take to get to the next level?

How is a company positioned against others?
How is a company positioned against others?


Want to learn more?

DOWNLOAD THE INFOGRAPHIC [PDF]

DOWNLOAD THE FULL REPORT [PDF]





Connections

Connections

For more information contact:

Dave Evans: dave.a.evans@accenture.com
Stephen Castellano: stephen.castellano@accenture.com


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Recommendations

Recommendations

Many if not most companies struggle with some combination of issues related to data capability, metadata management, and governance dimensions. The questions for many organizations are: how to keep making progress toward data standardization given the scarcity of resources and experience, and—once data standardization efforts are in flight—how to ensure that the potential benefits are captured?

To help companies resolve these issues Accenture developed a Clinical Data Standards Capability Maturity Model (figure). Using the model as a guide allows companies to take a methodical approach to moving through five distinct levels of maturity in each dimension, a journey that can be expedited by targeted assistance from third-party providers. Ultimately, companies that reach level 4 or 5 will reap the most business benefits from data standardization, as well as ensure regulatory compliance.


The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are vendor-neutral, platform-independent and free.