Archive for the 'ARISg™' Category

Go-Live agHub – the data warehouse for OSYRIS

ARISg™ Comments Off on Go-Live agHub – the data warehouse for OSYRIS

Successful go-live with agHub as a SAAS solution for Abbott EPD.

For details see also the project scope

Go-Live OSYRIS

ARISg™ Comments Off on Go-Live OSYRIS

Successful go-live with ARISg and agXchange version 7.2.2.4 as a SAAS solution for Abbott EPD.

For details see also the project scope

Start of the OSYRIS project (ARISE-Upgrade)

ARISg™, Drug safety systems Comments Off on Start of the OSYRIS project (ARISE-Upgrade)

ARISE is a complex and highly customized working environment used by Abbott EPD PV and ANI PV to capture, process, assess and distribute ICSRs. The purpose of the upgrade is to implement ARISg Version 7.2, out-of-the-box, without any customization, in a SaaS configuration (i.e. hosted in the cloud by ArisGlobal).  The kernel of the system is a standard application developed by ArisGlobal with a large number of peripheral components and add-ons. The current version of the kernel (ARISg Version 6.4) is not compliant with the E2B(R3) standard that will become effective by the middle of 2016. After upgrade, all peripherals internally hosted will be decommissioned.

OSYRIS = Operational SYstem for Reporting and Information on Safety

Go-live is scheduled for June 2017

VOEGELIN system engineering will provide the project management expertise and will support the project teams in Germany, US and India

Successful go-live with ARISE 1.1

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The ARISg post-marketing workflow has been amended with an additional activity to ensure the assignment of a company causality assessment for each Adverse Event pertaining to a solicited report sourced from a non-interventional study or programme. The automated distribution/submission logic has been modified to exclude unrelated Adverse Event reports from being distributed and/or submitted.

VOEGELIN system engineering was providing the project-management for this project at Abbott EPD.

Successful go-live with Abbotts new ARISE 1.0 PV system

ARISg™, Drug safety systems Comments Off on Successful go-live with Abbotts new ARISE 1.0 PV system

As a result of Abbott’s recent business separation decision, Abbott EPD has established an independent pharmacovigilance (PV) unit. In order to ensure that both Abbott EPD and AbbVie are able to fully comply with all regulatory requirements related to adverse events reporting, it was necessary to implement separate PV systems and associated support functions.

The project consisted of several major steps:
1. Cloning AbbVie’s PV environment (ARISg) and subsystems (PV-Track, IRT, Oracle Empirica)
2. Configuration changes
3. User Acceptance testing
3. Business- and IT-SOP review and modification
4. Setting-up required support functions

VOEGELIN system engineering was providing the project-management for Abbott EPD and the coordination of go-live tasks with Abbott Nutrition.

Argus safety™ 4.1 case data migration

Adam & Eve™, Argus safety™, ARISg™, Drug safety systems No Comments »

The integration of the Adam & Eve™ safety system (Sandoz) and the ARISg™ data (BMS) into Novartis Pharma Argus safety™ 4.1has been successfully completed.

Argus safety™ 4.1 case data migration

Adam & Eve™, Argus safety™, ARISg™, Drug safety systems No Comments »

Start of the legacy case migration project at Sandoz. Both systems, Hexal (Adam & Eve™) and BMS (ARISg™) will be migrated into Novartis Pharma global drug safety system, Argus safety™ 4.1. This project runs in a validated environment and the go live is planned to be in March 2007.