SocraMetrics GmbH

SocraMetrics GmbH is a German service provider based in Erfurt that specialises in professional data management, biostatistics, pharmacokinetics and pharmacovigilance for clinical research. According to its official website, the company has been active in data management, biometrics and pharmacokinetics since 1998, initially as a department of SocraTec R&D, and has operated as an independent company since 2007, the year SocraMetrics was founded. Its team designs data management solutions tailored to each clinical study or data management project, covering app-supported electronic data capture systems such as eCRF and ediary as well as paper-based approaches. The company states that it works according to internationally accepted IT standards, describing GAMP-5 and CFR 21 Part 11 as lived practice, with validated IT systems and programming as a matter of course, regardless of whether a client plans approval in the European Union, the United States or other regions of the world. Its statisticians develop solution concepts for clinical trials, and SAS-based, validated programming is used to produce reliable results. Highly qualified pharmacokineticists develop evaluation strategies in the early phase and support pharmacodynamic questions in Phase II. CDISC-based data structures are used to create submission-ready datasets, up to SDTM and ADaM submission packages for FDA submissions. SocraMetrics also offers the complete spectrum of pharmacovigilance services for national and international studies. Its pharmacovigilance and vigilance service covers the mandatory monitoring of drug safety for sponsors of clinical trials and for marketing authorisation holders or applicants. Beyond legally compliant handling of reports of adverse drug reactions, this includes assessment of the benefit-risk profile of an active substance or medicinal product. Vigilance obligations also exist for medical devices. SocraMetrics describes itself as a one-stop shop for pharmacovigilance and vigilance for pharmaceutical companies, establishing and maintaining pharmacovigilance systems and coordinating worldwide project management for its clients. It can cover either all of a pharmaceutical company's obligations or only partial aspects, depending on the company structure. The company advises clients from the first step of planning a clinical study and covers all aspects of pharmacovigilance across the entire product life cycle, from study through authorisation to the regular marketing process. Its team can also act as the person responsible for pharmacovigilance for the pharmaceutical company, including EU-QPPV, UK-QPPV and Stufenplanbeauftragter in Germany. Services for sponsors of clinical trials include worldwide pharmacovigilance services, provision of the safety officer, creation and maintenance of test plans, investigator information, periodic safety reports such as DSURs, safety management plans, and processing and reporting of safety-relevant reports. The company presents itself as a long-standing, inspection-tested partner for pharmaceutical companies and clinical research sponsors.

SocraMetrics GmbH traces its origins to 1998, when the activities that would become its core business began as a department of SocraTec R&D. According to the company's official website, it has been a successful provider of data management, biometrics and pharmacokinetics since 1998. In 2007, SocraMetrics was founded as an independent company, separating from SocraTec R&D while continuing the same service lines. The company is based in Erfurt, Germany, and describes itself as a service provider for professional data management, biostatistics, pharmacokinetics and pharmacovigilance. Over time the company expanded its portfolio. Its website notes that a pharmacovigilance team was newly added, complementing the existing data management, biostatistics and pharmacokinetics services. The pharmacovigilance offering grew into a one-stop shop covering the entire product life cycle, from clinical study planning through authorisation to regular marketing, and includes acting as the qualified person responsible for pharmacovigilance in the EU, the UK and Germany. The company emphasises inspection-tested experience and compliance with international IT standards such as GAMP-5 and CFR 21 Part 11, and it supports submissions in the European Union, the United States and other regions, including CDISC-based SDTM and ADaM packages for FDA submissions.

• 2007

  SocraMetrics is founded as an independent company, separating from SocraTec R&D.

• 1998

  Data management, biometrics and pharmacokinetics activities begin as a department of SocraTec R&D.

• A pharmacovigilance team is newly added to the service portfolio.

Contract research service provider for clinical data management, biostatistics, pharmacokinetics and pharmacovigilance, working to international IT standards such as GAMP-5 and CFR 21 Part 11.

• Clinical data management

  Tailored data management solutions for clinical studies, including app-supported electronic data capture such as eCRF and ediary, as well as paper-based approaches.

• Biostatistics

  Experienced statisticians develop solution concepts for clinical trials; SAS-based, validated programming produces reliable results.

• Pharmacokinetics

  Highly qualified pharmacokineticists develop evaluation strategies in the early phase and support pharmacodynamic questions in Phase II.

• CDISC submission packages

  CDISC-based data structures result in submission-ready datasets, up to SDTM and ADaM submission packages for FDA submissions.

• Pharmacovigilance and vigilance

  One-stop shop for pharmacovigilance and vigilance for pharmaceutical companies, covering the entire product life cycle and acting as EU-QPPV, UK-QPPV or Stufenplanbeauftragter in Germany.

1. 1SocraMetrics GmbH Erfurt - Datenmanagement und Statistiksocrametrics.de
2. 2Pharmakovigilanz Services für pharmazeutische Unternehmensocrametrics.de
3. 3SocraMetrics GmbH (Germany) - Wikidatawikidata.org