Services

clinical trials

Advanced knowledge in clinical trials, CRO integration and data transfer

pharmacovigilance

Advanced knowledge in pharmacovigilance, guidelines on ICH E2B (R3), GVP, GMP, AE reporting EMA/FDA, PSUR, DSUR, Signal detection and Risk management

projects

Analysis, design/planning and execution of project for pharmaceutical companies.

Technical and Process Consulting for Pharmaceutical companies, define company specific solutions

computer system validation

Computer System Validation for IT applications at GxP and non GxP environment. Pharmacovigilance system implementation und upgrades.

F.A.Q.

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ARISg /LSSMV

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VigiS3

VigilanceONE

PcVmanager

Empirica Trace

Computer System Validation after system implementation, system migration, system update, data migration, data cleaning. Change management planning and performing in Sandbox/ACC/Prod environment. Documentation with
VP, URS, RA, IQ, OQ, PQ, VS, and test scripts.
Gateway configuration and registration to Eudravigilance (EMA), MHRA and FDA.

VM Tools, SharePoint, SAP Solution Manager, MS Project, WebEx, TeamViewer