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Clinical Data Standards and CDISC Expertise

Our clinical data standards experts enhance Rho's timely submissions

Clinical Data Standards is one of the services most in demand by our clients. Our 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 in CDISC data standards improves the likelihood of successful submissions.

Our experts understand a wide range of industry clinical 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 is a leader in the development and adoption of CDISC standards, including CDASH, SDTM, and ADaM

Rho's employees have been closely 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 data 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 clinical data standards will be put to good use in determining the specific needs of your project.

 

Download our FSP datasheet

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