Archive for the 'Drug safety systems' 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

ARISg™, Drug safety systems Comments Off on Successful go-live with ARISE 1.1

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.

Go-live E2B gateway for Vigiflow™ 5.0

Drug safety systems, E2B Gateway, Miscellaneous, Vigiflow™ Comments Off on Go-live E2B gateway for Vigiflow™ 5.0

Successful go-live with the new E2B Gateway for automatic transmission (send & receive) of ICSRs.

The project involved the development and implementation of a gateway (IBM DataPower XB-62) for exchanging ICSRs electronically in E2B format along with an electronic acknowledgement that the reports have been received (ACK-log).

Currently the gatway supports the AS1 and AS2 communication methods.

For details see also the project scope

Go-live with Argus Safety 7.0.1

Argus safety™, Drug safety systems, Oracle™ Comments Off on Go-live with Argus Safety 7.0.1

Today, Helsinn Pharmaceutical switched to the successfully upgraded Argus Safety 7.0.1 version.

This upgrade process included the following steps:

– OS upgarde from MS Windows Server 2003 to 2008
– Oracle 10.2 – 11g R1 – 11g R2
– Argus Safety™ 4.2 SP2 – 5.0 – 5.0.1 – 5.0.2 – 5.1 – 6.0.1 – 7.0 – 7. 0.0.1 – 7.0.1

VOEGELIN system engineering provided the requested technical skills, run-scripts documentation as well as all necessary DBA activities for this major upgrade.

Pilot phase E2B gateway for Vigiflow™started

Drug safety systems, E2B Gateway, Miscellaneous, Vigiflow™ Comments Off on Pilot phase E2B gateway for Vigiflow™started

Today  the productive pilot phase has started. In this phase the national health authority is connected to the industry using a E2B gateway in order to exchange automatically (send/receive)  ICSR’s with Novartis, UCB, Lilly, Glaxo and Gilead.

The gateway is a IBM datapower XB-62 supporting AS1 and AS2 communication methods. The PV-system is Vigiflow™ 4.3.1 from the Uppsala Minitoring Center. End of November 2012 an upgrade to Vigiflow™ 5.0 is planned.

Test-Environment for Argus Safety™ 7.0.1 up and running

Argus safety™, Oracle™ Comments Off on Test-Environment for Argus Safety™ 7.0.1 up and running

After three month of exploration, debugging, installation as well as reading hundreds of pages (release notes, installation guides etc.) we have been successful in upgrading Argus safety™ Version 4.2 Sp2 to Version 7.0.1 for a international pharmaceutical company.

This upgrade process includes the following steps:

– OS upgrade from MS Windows Server 2003 to 2008
– Oracle 10.2 – 11g R1 – 11g R2
– Argus Safety™ 4.2 SP2 – 5.0 – 5.0.1 – 5.0.2 – 5.1 – 6.0.1 – 7.0 – 7. 0.0.1 – 7.0.1

Upgrade Argus safety™ 4.2 to version 7.0

Argus safety™, Drug safety systems Comments Off on Upgrade Argus safety™ 4.2 to version 7.0

VOEGELIN system engineering has been selected as service provider to perform the upgrade of Argus safety™ 4.2 to version 7.0 for an international pharmaceutical company. The upgrade consists of several steps:

  • Server
  • Operating system
  • Oracle database
  • Argus safety
  • MedDRA

It is planned to go live by end of Q3 / 2012.