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.
Your clinical study is in good hands with us!
- 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
We are always there for you, our team is looking forward to supporting you with your questions at any time.
And that since 1998!
- 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.
And that unites us!
- 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.
Not only clinical studies - we are broadly positioned!
- 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