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Pharmacovigilance

Pharmacovigilance und Vigilance Service

Pharmacovigilance, the monitoring of drug safety, is mandatory for sponsors of clinical trials and for marketing authorisation holders or applicants for a marketing authorisation. This is not only about the legally compliant handling of reports received about adverse drug reactions, but in particular about the assessment of the risk-benefit profile of an active substance or a medicinal product.
There are also mandatory vigilance tasks for medical devices.

SocraMetrics offers the one-stop shop around pharmacovigilance/vigilance for pharmaceutical companies. Our team, with its many years of inspection-proven experience, sets up and maintains pharmacovigilance systems and coordinates our clients' global project management. In doing so, SocraMetrics can either cover the entire obligations of the pharmaceutical company or only partial aspects - depending on the company structure.

We support companies from the very first step when it comes to planning a clinical trial, and our services cover all aspects of pharmacovigilance and thus the entire life cycle of the product: from the trial to the marketing authorisation and the regular marketing process.

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).

Services for sponsors of clinical trials:

  • Global pharmacovigilance services
  • Provision of the Drug Safety Officers
  • Generation and maintenance
    • Protocols
    • Investigator’s information
    • Development safety update reports, DSURs
    • Safety Management Plans
  • Processing and reporting of safety-relevant reports
  • Literature search
  • Preparation and maintenance of the clinical quality systems
  • GCP-Trainings

Services for applicants of & marketing authorisation holders

  • Global project and contract management
  • EU-QPPV, UK-QPPV, Graduated Plan Officer, Safety Officer for Medical Devices
  • Preparation and maintenance of Pharmacovigilance System Master File (PSMF)
  • Preparation and maintenance of Risk Management Plans (RMPs)
  • Preparation and maintenance of Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs)
  • Post Authorisation Safety Studies (PASS) and Post Authorisation Efficacy Studies (PAES)
  • Signal detection
  • Handling of Adverse Drug Reactions and other safety-relevant information
  • Management of pharmaceutical-technical risks of medicinal products and medical devices
  • Literature search
  • Preparation and maintenance of the Pharmacovigilance Quality System
  • GVP training
  • Management of pharmakovigilance audits and inspektions
  • Medical assessments

For more information you can download our info-flyer as pdf file.

Download Pharmacovigilance Flyer (1.19 Mb) PDF

We will answer your questions.
Caroline Matthey is at your disposal.

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