Software package and information systems
Swissmedic, Informatik Beschaffungsmanagement | Published December 11, 2015 - Deadline February 8, 2016
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Swissmedic, the Swiss Agency for Therapeutic Products, is Switzerland's central regulatory and control authority for therapeutic products. Swissmedic's statutory mandate is set out in the Federal Act of 15.12.2000 on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA; SR 812.21). As a federal public institute based in Berne, Swissmedic is independently organised and managed, and has its own budget.
The core tasks of Swissmedic comprise:
— Authorisation of medicinal products,
— Issuing licences for manufacturing and wholesale trading and conducting inspections,
— Market surveillance of medicinal products and medical devices,
— Penal law,
— Clinical trials of therapeutic products and laboratory testing of the quality of medicinal products,
— Drawing up legislation and standards,
— Providing information to the public,
— National and international cooperation.
Further details can be found at: www.swissmedic.ch
Once medicinal products are on the market, they are subject to regulatory control. As part of its legal mandate, Swissmedic collects and evaluates reports of adverse drug reactions (ADRs) from primary reporters, in other words healthcare professionals (such as doctors, pharmacists and chemists), pharmaceutical companies and patients.
These ADRs are currently collected and processed in the national VigiFlow database. This database is currently hosted and operated on Swissmedic's behalf by the Uppsala Monitoring Centre (UMC) in Sweden. The data is incorporated into the global VigiBase database, which is operated by the UMC, and is used to provide reports and consultation documents to the World Health Organization (WHO) and its member states, based on the analysis of individual case safety reports (ICSRs). Additional information on the UMC can be found here: http://www.who-umc.org
VigiFlow no longer meets Swissmedic's requirements in terms of a modern pharmacovigilance tool that also offers better process support and evaluation functions for business case processing. As a result of a recent strategy review, UMC will probably only continue to support the operation of VigiFlow (enhanced version for Swissmedic) until the end of 2017. VigiFlow itself is to be replaced by a new tool that is geared to the needs of low income countries. Swissmedic therefore intends to replace VigiFlow with an up-to-date Adverse Event Reporting System (AERS) that is tailed to actual requirements by the end of 2017 at the latest.
To this end, Swissmedic is seeking a supplier that can provide, in the requisite quality, a suitable standard software system plus the additional developments and services that are needed to implement this software in the Swissmedic IT architecture. The existing database from the current system will have to be imported into the new system as part of the implementation project.
To cover the planned life cycle of the software, a 10 year master agreement with an option to extend for a further 5 years will be concluded with the successful bidder. Individual work assignments to be performed during the term of the master agreement will be subject to separate individual contracts. Once the software has been successfully implemented, the bidder must be available to maintain and support the software throughout the duration of the master agreement. Furthermore, the bidder must, if necessary provide additional integration services, if this is required as a result of changes in Swissmedic's IT architecture or if desired for other reasons.
Swissmedic's IT environment is operated by the Swiss Federal Office of Information Technology, Systems and Telecommunication (FOITT). The FOITT provides it with computer centre, data communications and office automation services, a workstation infrastructure and associated services (PCs, notebooks and multifunction printers) as well as central security, gateway, identity and access management solutions. The software procured as result of this invitation to tender will likewise be operated at the FOITT.
For specialist applications, Swissmedic also procures system operating services from the FOITT up to, and including, operation of the database management system. Swissmedic organises applications support, software product maintenance and the further development of solutions with third parties. Full details can be found in the System Specification for the invitation to tender.