The subject of the contract is comprehensive monitoring, supervision over the safety and data of the SAPHO Clinical Trial. Project financed by the Medical Research Agency (Co-financing Agreement No. 2022/ABM/01/00003-00).
The subject of the contract is comprehensive supervision over the implementation of a clinical trial under the project: Multicenter, randomized, double-blind clinical trial evaluating the efficacy and safety of etanercept compared to placebo in the treatment of patients with SAPHO syndrome. Project financed by the Medical Research Agency (Co-financing Agreement No. 2022/ABM/01/00003-00).
The scope of the contract includes:
Comprehensive clinical trial service including monitoring, supervision of implementation, safety and data A clinical trial planned under the project Multicenter, randomized, double-blind clinical trial evaluating the efficacy and safety of etanercept compared to placebo in the treatment of patients with SAPHO syndrome, hereinafter referred to as the Trial, in accordance with the applicable regulations of the European Medicines Agency governing the conduct of clinical trials, guidelines Good Clinical Practice of the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, the Declaration of Helsinki and applicable national regulations (regarding the country in which the clinical trial will be conducted), including:
Management, organization and conduct of the survey in:
-Prof. Eleonora Reicher National Geriatrics, Rheumatology and Rehabilitation Institute, Spartańska 1, 02-637 Warsaw
-Rheumatology Clinic of the University of Warmia and Mazury in Olsztyn, al. Wojska Polskiego 35, 10-228 Olsztyn
-Department of Internal Medicine, Rheumatology, Diabetology, Geriatrics and Clinical Immunology, Pomeranian Medical University in Szczecin, Unii Lubelskiej 1, 71-252 Szczecin
Organizing and conducting the Trial on behalf of the Clinical Trial Sponsor (Ordering Party). A detailed description of the subject of the contract is included in Annex 2 to the SWZ.