Mandate Category: Audits

CDMS / eCRF Vendor Audit

Perrin Consulting was mandated by AMS Advanced Medical Services, München (D) and Roche Pharma AG, Grenzach (D) to perform a vendor audit of MedicalSyn GmbH, Dresden (D) in September 2017. MedicalSyn provides a Multiple Sclerosis Documentation System called MSDS3 which includes a Clinical Data Management System (CDMS) as well as an electronic Case Record Forms (eCRF).

PV System Audit at Institut de Recherches Internationales SERVIER I.R.I.S

Perrin Consulting was mandated through the intermediary of Oxford Global Resource Ltd. to perform a system audit of Serviers pharmacovigilance (PV) system in June 2016. Servier operates Argus Safety v6.0 as global PV system and is in the planning phase for an upgrade project.

Audit of Clinical Data Management Service provider

Perrin Consulting was mandated by AMS Advanced Medical Services to conduct a follow-up audit of its clinical data management service provider Quadratek Data Solutions Ltd. Berlin. The audit took place 13. & 14. April 2016 at the premises of Quadratek Data Solutions in Berlin DE.

Audit of Data Management CROs for Astellas

In July 2015 and September 2015 Perrin Consulting performed follow-up audits of SGS Life Science and Syneed MediData for Astellas Pharma Europe. The two CROs provide data management and statistical services to Astellas Pharma Europe.

GMP Audit for Bencard Allergy GmbH

The manufacturing and packaging process of a supplier of medicinal products was audited in December 2014 after recent changes in the process.