As part of TechnoSTAT’s one-stop-shop resource for data management and statistical services, TechnoSTAT Clinical Services is proud to provide complete state-of-the-art services to meet CDISC compliance.
CDISC (Clinical Data Interchange Consortium) was founded in 1997 in order to streamline collection and submission of both clinical and non-clinical data. The US FDA now requires compliance with CDISC standards in all drug (NDA) and biologics (BLA) submissions and recommends using CDISC standards for electronic submissions of all clinical data. Similar requirements are in use by Japan’s PMDA and other regulatory agencies (e.g. EMA) are expected to follow suit in the near future.
TechnoSTAT has remained one step ahead of industry development, preparing clinical databases for electronic submission for over a decade, including application of CDISC standards long before it was a regulatory requirement. TechnoSTAT is a CDISC Registered Solutions Provider, certifying TechnoSTAT’s ability to provide assistance to organizations in implementing CDISC models.
Our expertise qualifies us to meet your CDISC compliance needs in an efficient and high-quality manner. Your data is the most important outcome of your clinical trial and is the result of a large investment – make sure your data stands up to the regulatory standards.
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