Validating cdisc sdtm compliant submission ready clinical datasets

Posted by / 07-May-2020 15:59

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) switched to CDISC standards on October 1, 2016 and now requires that all submissions filed on or after October 1, 2016 to use CDISC compliant formats.

Click here or call 888.615.5111 today, to contact a member of our expert PK CDISC team to learn more about CDISC and to see if your datasets are in compliance with the FDA’s soon-to-be required CDISC Standards.But would it save money now instead of later in the close-out phase?If there is a shortage of funding this may not allow the CRO or service provider all the opportunities that would assist them in capturing the information they need as per CDISC standards.Funding also plays a key challenge for CDISC-compliance data collection study.Small researchers or biotechnology companies that do not have the resources in-house, out-sourced this task to CROs or service providers and are not interested whether it is compliance as long as it is save them money.

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Proper implementation of CDISC standards can decrease timelines and costs during drug development leading to a marketing authorization.

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