Product/Service

Data Standards

Source: Rho

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Data Standards is one of Rho's strongest capabilities and one of the services most in demand by our clients. Our company's distinct advantage is our knowledge of the standards and the tools we have developed to support their use.
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Data Standards is one of Rho's strongest capabilities and one of the services most in demand by our clients. Our company's distinct advantage is our knowledge of the standards and the tools we have developed to support their use. The tools we use create additional time and opportunities to investigate the data. Our experience and expertise improve the likelihood of successful submissions.

Our experts understand a wide range of industry data standards and apply them to the needs of individual studies. We can collaborate with clients to ensure the appropriate standard is implemented from the beginning. And for existing studies that do not adhere to a specific standard, we leverage knowledge, tools, and experience to transform metadata and produce deliverables that conform to an industry-wide or sponsor-specific standard.

The overall deliverable is a submission database that U.S. FDA or European Medicines Agency (EMEA) reviewers can use to easily confirm study analyses. This gives regulatory agencies confidence in the submission with fewer queries and an expedited review so that the drug may go to market sooner. We also deliver post-submission support for any queries your project may receive.

Rho's employees have been deeply involved in the creation of the industry-wide Clinical Data Interchange Standards Consortium (CDISC) data standards and continue to participate in the CDISC organization. Because of our early connection with the evolving biotechnology, medical device, and pharmaceutical data standards, we developed industry-leading CDISC-compliant tools to implement these new standards into our work, further enhancing the efficiency we bring to our clients' programs. Rho can design studies to support the current CDISC standard, a future version, or legacy versions as project needs dictate. These tools allow for submission databases that are consistent across each study and compliant with FDA standards and expectations.

The benefits of CDISC compliance are many, but there are short-term considerations to keep in mind. Rho's expertise in CDISC and other data standards will be put to good use in determining the specific needs of your project.

These benefits all add up to greater quality in data submissions as well as more efficient reviews, which ultimately streamline our clients' clinical trial programs. As the FDA moves toward establishing CDISC as the standard, Rho is positioned to continue as an industry leader in helping our clients to meet these requirements.

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