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With its expertise and proprietary tools, AdClin supports its clients in the production of SDTM, ADaM, and SEND packages, the critical review of externally produced packages, as well as the preparation of BIMO deliverables for the FDA. Its expertise also extends to the pooling of multi-study data and strategic consulting on the implementation of regulatory standards.

SDTM/ADaM Packages & TFL

AdClin produces high-quality SDTM/ADaM packages thanks to the powerful tools it has developed, enabling it to validate all the different steps from raw data to TFL, ensuring optimal traceability
Raw ➔ SDTM ➔ ADaM ➔ TFL.

SEND Packages

AdClin produces high-quality SEND packages thanks to the powerful tools it has developed, enabling it to validate all the different steps from raw data to SEND datasets, ensuring optimal traceability
Raw ➔ SEND.

SDTM/ADaM Packages Review

AdClin has unique expertise in SDTM/ADaM standards and powerful tools that allow it to verify the compliance of packages produced by other companies.

BIMO Deliverables

AdClin supports companies in delivering the required deliverables for the FDA's Bioresearch Monitoring (BIMO) program, while adhering to the required formats.

Pool of Clinical Studies

AdClin has strong expertise in standardizing data from a large number of clinical studies, facilitating their pooling.

CDISC Training

AdClin provides SDTM/ADaM training for both experts and beginners.

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75011, Paris, France
contact@adclin.com
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Useful Links

  • Clinical Data Interchange Standards Consortium (CDISC)
  • U.S. Food and Drug Administration (FDA)
  • Pharmaceutical and Medical Devices Agency (PMDA)
  • European Medicines Agency (EMA)