Clinical Research Management and Monitoring Services

This contract involves the management and monitoring of a non-commercial clinical trial titled "Open-label, single-arm, dose-escalation study to assess the safety of locally produced CAR-T anti-CD19 lymphocytes in adult patients with aggressive B-cell lymphomas in second-line treatment (CARMEN)." The service will be provided as part of a project funded by the Medical Research Agency, aimed at developing an optimal strategy for the production and administration of CAR-T lymphocytes in adults and children with B-cell non-Hodgkin lymphomas and acute lymphoblastic leukemia. Key details include: - Sponsor: Wrocław Medical University - Consortium Partner: Regional Blood Donation and Blood Treatment Center in Poznań - Principal Investigator: Prof. Dr. Hab. Tomasz Wróbel - Project Duration: 30 months - Number of Centers: 1 (2 locations) 1) Hematology, Cellular Therapy, and Internal Diseases Clinic 2) Bone Marrow Transplantation, Oncology, and Pediatric Hematology Clinic - Total Number of Patients: 18 The services will be performed at: 1) Hematology, Cellular Therapy, and Internal Diseases Clinic, USK, Wybrzeże Ludwika Pasteura 4, 50-367 Wrocław 2) Bone Marrow Transplantation, Oncology, and Pediatric Hematology Clinic, USK, ul. Borowska 213, 50-556 Wrocław The contract details are outlined in the Detailed Description of the Subject of the Order (Annex 1 to the SWZ), the Detailed Cost Estimate, and the Schedule of Tasks and Payments (Annex 3 to the SWZ). The total budget for this contract is 1,050,000.00 PLN, with a possibility of supplementary orders up to 20% of the basic contract value within 3 years. Supplementary orders may include updates to clinical trial documentation, additional consultation hours, extension of the study duration, and an increase in the number of patients. The basic contract value is 1,232,500.00 PLN, with supplementary orders valued at up to 246,500.00 PLN, totaling a net value of 1,479,000.00 PLN. Additionally, the contractor is required to employ staff under an employment contract as per the Labor Code for roles related to the management and monitoring of the clinical trial and eCRF system support, specifically for the Project Manager and Study Monitor.