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CDISC

CDISC

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.
Mrs. Dr. K. Mittmann is at your disposal.

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New GCP Training Courses now available at SocraTec R&D

Our sister company SocraTec R&D has now added GCP training courses to their service portfolio.


From now on you can book the following training courses through their website:


Grundlagenkurs für Mitglieder eines Prüfungsteams bei klinischen Prüfungen nach der Europäischen Verordnung (EU) Nr. 536/2014 (Humanarzneimittel)


Aufbaukurs für Prüfer und Hauptprüfer bei klinischen Prüfungen nach der Europäischen Verordnung (EU) Nr. 536/2014 (Humanarzneimittel)


So if you are interested in taking these classes, go to the SocraTec R&D website to learn more. The first GCP training alreday starts in May 2023.


https://socratec-pharma.de/services/gcp-courses