Tenders Are Invited For Research And Experimental Development Services - Provision Of Services Consisting In ... in Poland

Work Detail

Research And Experimental Development Services - Provision Of Services Consisting In The Performance Of Tasks Entrusted By The Sponsor Related To The Implementation Of A Non-Commercial Clinical Trial (Nefryt) In Two Centers - The Institute Of Mother And Child And The State Medical Institute Of The Ministry Of Internal Affairs And Administration, Along With The Preparation, Configuration And Provision Of The Electronic Clinical Observation Card Ecrf System (...). The Subject Of The Order Is The Provision Of Services Consisting In The Performance Of Tasks Entrusted By The Sponsor Related To The Implementation Of A Non-Commercial Clinical Trial (Nefryt) In Two Centers - The Clinic Of Obstetrics And Gynecology Of The Institute Of Mother And Child And The Clinic Of Urology And Oncological Urology, State Medical Institute Of The Ministry Of Internal Affairs And Administration, Together With The Preparation, Configuration And Provision Of The Electronic Clinical Observation Card Ecrf (Electronic Case Report Form) Together With The Iwrs Module (Interactive Web Response System), As Part Of The Project Called: As Part Of The Project Called: Randomized, Multicenter, Open Phase Iii Study Comparing The Effectiveness And Safety Of The Use Of Pregabalin, Sacral Neuromodulation (Snm) And Tibial Nerve Neuromodulation Using An Implant (Itns) In Patients With Resistant Overactive Bladder. (Nefryt), Implemented Under Agreement No. 2025/Abm/01/00005 - 00 Of February 20, 2026 Concluded With The Medical Research Agency. A Detailed Description And Method Of Execution Of The Order Is Included In The Description Of The Subject Of The Order (Opz) And The Contract Template, Constituting Annex No. 3 To The Swz And Annex No. 4 To The Swz, Respectively. The Ordering Party Does Not Allow The Submission Of Partial Offers. The Subject Of The Order Is A Comprehensive Service Consisting In Supervision Over The Implementation Of A Non-Commercial Clinical Trial In Two Centers In Poland And The Preparation, Configuration, Provision And Maintenance Of The Electronic Clinical Follow-Up Card (Ecrf - Electronic Case Report Form) System. The Ordering Party Does Not Allow The Submission Of Partial Offers. Justification For Not Dividing The Order Into Parts The Subject Of The Order Is A Comprehensive Service Consisting In The Supervision Of The Implementation Of A Non-Commercial Clinical Trial In Two Centers In Poland And The Preparation, Configuration, Provision And Maintenance Of The Electronic Clinical Follow-Up Card (Ecrf - Electronic Case Report Form) System. The Ordering Party Did Not Envisage Dividing The Contract Into Parts Due To The Fact That Such A Division Could Negatively Affect The Proper Implementation Of The Subject Of The Contract, Both In Technical, Organizational And Financial Terms. The Detailed Justification Is Provided Below: 1) Excessive Technical Difficulties: Execution Of The Order Requires Close Cooperation Between The Clinical Trial Supervision Services And The Ecrf System, Which Is A Key Tool For Conducting And Monitoring The Trial. Division Of The Contract Could Lead To Lack Of Compatibility Between Systems And Tools Used By Different Contractors, Which Would Result In Difficulties On Several Levels, Including: A) Ensuring Compatibility Of Data Formats And Structures Used In The Systems Of Individual Contractors, B) Proper Design Of The Ecrf Based On The Research Protocol, Which Requires Prior Validation And Approval By The Relevant Authorities (Urpl, Bioethics Committee), C) The Need For Subsequent Modifications

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