It Services: Consulting, Software Development, Internet And Support – Offer Of Contract For A Side Effect System. The Danish Medicines Agency Wishes To Enter Into A Contract For The Establishment, Maintenance, Support And Further Development Of A Side Effect System. The Danish Medicines Agency Must Use The Side Effect System To Support Tasks Relating To The Collection, Registration And Analysis Of Suspected Side Effects Of Medicinal Products. The System Must Support The Entire Case Processing, Including The Reception, Processing And Forwarding Of Reports To The European Side Effect Register Eudravigilance (Ev). The Board Receives Approx. 6,500–7,000 Reports Annually. The Board Is Obliged To Forward Reports To Ev. The System Must Be Connected To The Danish Medicines Agencys Database, Which Contains Data On All Registered Adverse Event Cases In Denmark Over The Last Approx. 50 Years. Selected Data Must Also Be Exported To The Danish Medicines Agencys Publicly Available Interactive Side Effect Summaries (Idaps). The System Must Be Operated By The Danish Medicines Agencys Operating Supplier, With Whom The Supplier Will Have To Cooperate With, Among Other Things, Commissioning 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 Commissioned Tasks A) Establishment: Establishment Consists In The Supplier Making The System Available To The Danish Medicines Agency, Including - To The Extent Necessary, Configuring And Customizing The System To The Danish Medicines Agencys Needs, Including To Relevant Data Standards - Receiving Data From The Supplier Of The Customers Current System - Establishing Integrations (Including To The Customers Side Effect Database, Side Effect Reporting Solution (Bil) And Ev), - Testing The System - Establishing Access Conditions - Training Of Users - Assistance For Installation In The Danish Medicines Agencys It Environments (On Premise At The Danish Medicines Agencys Operating Supplier). - Prepare And Deliver Documentation B) Maintenance: The Supplier Must Maintain The Functionality Of The System, Including - Fix Errors In The Application - Deliver Updates To The System In The Form Of New Versions And Releases, Including Testing Of Such - Carry Out Security Updates, Including Corrections Of Identified Vulnerabilities. C) Support: The Supplier Must Provide 2Nd Level Support For The System, Including The Danish Medicines Agencys Side Effect Database And Integration Components, In A Setup Adapted To The Danish Medicines Agencys Normal Support Flow, Where The Danish Medicines Agencys Operating Suppliers Service Desk Receives And Distributes All Inquiries. D) Further Development And Other Ordering Tasks: The Danish Medicines Agency May, During The Term Of The Contract, Order Further Development And Other Ordering Tasks. Further Development Includes Customer-Specific Development Tasks Such As The Development Of New Functionality, New Integrations And Adaptation Of The Danish Medicines Agencys Database. Other Commissioned Tasks Include Advice On E.G. It Architecture, Security And Customer-Specific Solution Design, As Well As Operational Support For The Danish Medicines Agencys Operational Supplier, Including Assistance With Commissioning Of
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