Denmark – IT services: consulting, software development, Internet and support – Udbud af kontrakt om et bivirkningssystem

The Danish Medicines Agency wishes to enter into a contract for the establishment, maintenance, support and further development of an adverse reaction system. The Danish Medicines Agency will use the adverse reaction system to support tasks related to the collection, registration and analysis of suspected adverse reactions to medicinal products. The system must support the entire case processing, including the receipt, processing and forwarding of reports to the European adverse reaction register EudraVigilance (EV). The Agency receives approximately 6,500–7,000 reports annually. The Agency is obligated to forward reports to EV. The system must be connected to the Danish Medicines Agency's database, which contains data on all registered adverse reaction cases in Denmark over the past approximately 50 years. Selected data must also be exported to the Danish Medicines Agency's publicly accessible interactive adverse reaction summaries (iDAPs). The system must be operated by the Danish Medicines Agency's operational provider, with whom the supplier will need to collaborate on, for example, the implementation of new releases.

II. Main services:

The tendered contract includes the following main services:

A) Establishment

B) Maintenance

C) Support

D) Further development and other ordered tasks

A) Establishment: Establishment involves the supplier making the system available to the Danish Medicines Agency, including - Configuring and customising the system to the Danish Medicines Agency's needs, including relevant data standards, as necessary - Receiving data from the supplier of the Customer's current system - Establishing integrations (including with the Customer's adverse reaction database, Adverse Reaction Reporting Solution (BIL) and EV), - Testing the system - Establishing access conditions - Training users - Assisting with the installation of the Danish Medicines Agency's IT environments ("on premise" with the Danish Medicines Agency's operational provider). - Preparing and delivering documentation

B) Maintenance: The supplier must maintain the system's functionality, including - Correcting errors in the application - Delivering updates to the system in the form of new versions and releases, including testing of such - Performing security updates, including corrections of identified vulnerabilities.

C) Support: The supplier must provide 2nd level support for the System, including for the Danish Medicines Agency's adverse reaction database and integration components, in a setup tailored to the Danish Medicines Agency's normal support flow, where the Danish Medicines Agency's operational provider's service desk receives and distributes all inquiries.

D) Further development and other ordered tasks: The Danish Medicines Agency may order further development and other ordered tasks during the contract period. Further development includes customer-specific development tasks such as the development of new functionality, new integrations and adaptation of the Danish Medicines Agency's database. Other ordered tasks include consulting on, for example, IT architecture, security and customer-specific solution design, as well as operational support to the Danish Medicines Agency's operational provider, including assistance with the implementation of new releases.