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SocraMetrics

Your service provider for professional Data Management, Biostatistics, Pharmacokinetics and Pharmacovigilance

Our experienced team will work out the data management solution that is optimally tailored to your clinical study / Data Management project - whether App-supported electronic data capture systems such as eCRF or ediary or even paper-based - we have the customized solution for you.

  • We work according to internationally accepted IT standards - GAMP-5 and CFR 21 Part 11 are living practice for us, validated IT systems and programming are self-evident practice - regardless of whether you are planning a registration in the European Union, in the USA or in other regions of the world.
  • Our experienced statisticians develop the solution concept for your clinical trial
  • SAS-based, validated programming leads to reliable results
  • Our highly qualified pharmacokineticists develop your evaluation strategy in the early phase and accompany your pharmacodynamically oriented questions in phase II
  • CDISC-based data structures result in submission-ready datasets, up to SDTM and ADaM submission packages for your FDA submissions
  • For national and international trials we offer the full package of pharmacovigilance services
The team of SocraMetrics in erfurt

We are always there for you, our team is looking forward to supporting you with your questions at any time.

  • Since 1998, we have been a successful provider of services in the field of Data Management, Biometrics and Pharmacokinetics - initially as a division of SocraTec R&D, and then from 2007 as a newly founded independent company with the name of SocraMetrics.
  • Our newly added pharmacovigilance team brings with it many years of experience.
  • Our partner CRO SocraTec R&D is there for you if you are looking for a full-service solution - we work in partnership.
  • Team spirit, enthusiasm for the cause and solution-oriented thinking paired with creativity and pragmatism - this characterizes us as well as our partner SocraTec R&D.
  • Together with our customers, we are committed to find the optimal solution with enthusiasm and professionalism.
  • High reliability and fully QMS-supported processes are basic principles of which all employees are convinced.
  • Pharmacovigilance for applicants for medicinal product marketing authorisations and marketing authorization holders of medicinal products
  • Vigilance for medical devices
  • Non-interventional studies - commissioned (PASS, DUSS) or for other reasons
  • Customer surveys
  • Data Mining

We will answer your questions
Here, via e-mail or calling on phone

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