As part of TechnoSTAT’s one-stop-shop resource for data management and statistical services, TechnoSTAT 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 recommends using CDISC standards for electronic submissions of all clinical data and requires compliance with CDISC standards in drug and biologics submissions for all new clinical studies starting from 2017. Similar requirements by other regulatory agencies (e.g. EMA and PMDA) are expected in the near future.
TechnoSTAT offers CDISC services
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 CDISC services include:
- Building new CDISC-compliant databases according to the CDISC CDASH and SDTM standards for clinical database construction for new and legacy studies alike
- Creation of special CDISC SDTM domains for specific therapeutic areas
- Mapping of collected data to CDISC standards for integrated summaries of safety and efficacy (ISS/ISE) and FDA submission
- Compatibility with any version of the SDTM Implementation Guide
- Conversion of collected data to CDISC-compliant controlled terminology
- Construction of the CDISC “metadata” file (define.xml) that serves as the table of contents for the clinical database
- Creation of an analysis database in compliance with CDISC ADaM standards to support statistical analysis
- Statistical programming using CDISC ADaM-compliant datasets
- Developing client standards to ensure data consistency across phases and therapeutic areas which enables pooling and ensures data is submission-ready
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.