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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).

Oracle Argus implementation at Sanofi

Perrin Consulting has been appointed to support the Sanofi’s AEGIS program as Subject Matter Expert. The program will implement Argus Safety as global pharmacovigilance system at Sanofi.

Update 23-April-2016
Perrin Consulting was managing the system pilot were the future drug safety system was first exposed the end-user testing. The pilot took place from the 4. to 8. April 2016 at Sanofi in Chilly-Mazarin (F) .

Update 21-January-2017
Perrin Consulting supported the system configuration of Sanofis new Argus system by developing tools verifying the configuration. Configuration files were checked against the configuration specifications. Errors or mismatches were communicated to the configuration team for correction, if appropriate.

Perrin Consulting developed Performance Use Cases serving as basis for system performance testing using automated performance test tool.

Update 8-January-2018
Perrin Consulting will act as Validation Coordinator for the User Acceptance Testing (UAT) in France. Over 1000 UAT test scripts will be executed in France. Perrin Consulting will be in charge of the task coordination, logistics, non-conformance handling, and the post-approval process.

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.

Review of IT Quality System at Sartorius

Perrin Consulting and Empower Consulting AG have been mandated to provide an initial analysis of the quality system applied to IT systems at Sartorius AG, Göttingen D.

Phase one starts in January 2016 and will encompass the analysis of the SAP based computerized system(s).

GxP / CSV Training at Actelion

Members of the Global Drug Safety Systems group have received training in GxP system validation methodology. The training was tailored to the Quality System in place at Actelion. Recent updates to the Quality System have been be discussed and practical implementation approaches presented. The course was complemented by a 2 hour workshop.

Integrate Oracle Argus for Adjudication

Perrin Consulting is appointed to design a technical solution for integration of Oracle Argus data into the adjudication process provided by Ethical GmbH.

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.

Nordic Pharmacovigilance Day, 07-Oct-2014, Copenhagen

Together will colleagues from Actelion, L. Perrin was invited as speaker at the Nordic PV Day to talk about

Upcoming demands from the new GVP guidelines
A challenge to PV systems and how to address them (case study)

A general overview was presented along with two IT systems in operation at Actelion, supporting new requirements set by the GVP guideline.

 

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