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In accordance with US FDA standards, we prepare the CDISC Submission Package for you.

CDASH - Operational Database (ODS)
Tabulations (SDTM)
Analysis Datasets (ADaM)
Tables, Listings, Figures (TLF)
Specific validation
CDISC Submission Package

We will answer your questions regarding cdisc questions.
PD Dr. rer. nat. habil. Katrin Mittmann is at your disposal.

SocraMetrics now offers full-scope Pharmacovigilance Services!

News of August 1st, 2023

New service - SocraMetrics has extended the service portfolio and now provides professional level pharmacovigilance and vigilance services for pharmaceutical companies worldwide from clinical trials to marketing! 

For national and international trials we now offer the full package of pharmacovigilance services. Our highly qualified team also acts as the person responsible for pharmacovigilance for the pharmaceutical company (EU-QPPV, UK-QPPV, Graduated Plan Officer in Germany).

For more details see here.