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Gemäß US-FDA-Standard erstellen wir für Sie das CDISC Submission Package.

CDASH - Operational DataBase (ODS)
Tabulations (SDTM)
Analysis Datasets (ADaM)
Tables, Listings, Figures (TLF)
Projektspezifische Validierung
CDISC Submission Package

Für Ihre Fragen zur Aufbereitung Ihrer Daten nach CDISC-Standards stehen wir gern zur Verfügung.
Richten Sie Ihre Anfrage dazu an PD Dr. rer. nat. habil. Katrin Mittmann.

Don’t miss GBHI 24!

We are happy to share the upcoming 6th International Workshop - GBHI 2024, hosted by the PQRI/EUFEPS Global Bioequivalence Harmonisation Initiative. We at SocraMetrics push advancements in bioequivalence standards, with strong expertise in:

  • Transdermal therapeutic systems
  • Long-acting injectables
  • Orally inhaled drug products

It is our honor to announce that Barbara Schug of SocraTec R&D will be serving as a co-chair for this event, while Ralph-Steven Wedemeyer from SocraMetrics will use his elaborate expertise as part of the workshop planning committee. Join GBHI 2024 and be a part of the pivotal discussions that will lay the scientific foundation for the ICH M13 follow-on document that will set global standards for MR dosage forms.

Don't miss your chance to be a part of GBHI 2024, April 16-17, 2024, in Rockville, Maryland, US. Read the GBHI 2022 report and register for GBHI 2024.

Join us in advancing bioequivalence!

Program GBHI 2024