Validating cdisc sdtm compliant submission ready clinical datasets

The 1000+ automated checks help identify and sometimes resolve data issues before the data is sent to the FDA.

BDLS has a strong international presence in five countries in North America and Europe. BDLS is a CDISC Registered Solution Provider and provide expert consultancy and CRO services in areas such as the implementation of CDISC standards, the conversion of legacy data to CDISC or company standards, the validation of CDISC SDTM data and metadata, the implementation of clinical applications (CTMS, CDMS, RDC, ...), and the development of business intelligence applications to support the clinical development process (data warehouse preparation...).

The data conversion process uses tried and tested techniques based on tools optimized specifically for use in the conversion of clinical studies data to CDISC format, producing data ready for regulatory submission in SDTM, ADa M and standards.

Our team has converted data from numerous clinical trials, in diverse therapeutic areas, to CDISC-compliant SDTM and ADa M data sets, as well as designed CDASH compliant forms and databases for streamlined data management and reporting.

Business & Decision Life Sciences (BDLS) is part of the Business & Decision Group, an international consulting and Systems Integration Company founded in 1992 and listed on the Eurolist C exchange.

In addition to a suite of proprietary validation checks, we use Open CDISC, an open source technology, to load, review, and validate SDTM data and files.

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BDLS is specialized in the delivery of services and provision of solutions in the Life Sciences industry.With over 20 years of experience, it supports its clients in the pharmaceutical, medical device, biotechnology, food and cosmetics industries.

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