{"status":"OK","data":{"advertisement":{"id":242464,"title":"ZAPYTANIE OFERTOWE Nr 5/FENG-HAN/2024","partial_offer_allowed":false,"publication_date":"2024-02-05","submission_deadline":"2024-02-19 23:59:59","planned_sign_date":null,"supplementary_orders":null,"terms_of_contract_change":"Wszelkie zmiany w umowie, kt\u00f3ra zostanie zawarta w wyniku post\u0119powania, wymagaj\u0105 formy pisemnej, pod rygorem niewa\u017cno\u015bci\n\nAll modification to the agreement, which will be concluded as a result of the proceeding, must be in writing under pain of nullity","created_at":"2024-02-05 14:00:25","modified_at":"2024-02-20 00:00:03","contact_persons":[{"id":3621,"forename":"Ma\u0142gorzata","surname":"S\u0119ktas","phone_number":"+48 22 5936277","email":"m.sektas@cellis.eu","created_by":null,"created_at":"2026-03-20 13:48:06","modified_at":"2026-03-20 13:48:06","modified_by":null}],"orders":[{"id":393282,"estimated_value":null,"order_items":[{"id":443450,"description":"Monitorowanie badania klinicznego fazy I.\n\nPlanowana data rozpocz\u0119cia realizacji zam\u00f3wienia: 1.03.2027 r.\n\nNa wy\u017cej wymienione zam\u00f3wienie sk\u0142ada si\u0119:\n1. Rekrutacja do badania klinicznego fazy I.\nPrzyk\u0142adowe kryteria w\u0142\u0105czenia pacjent\u00f3w: \n\u2022\tpotwierdzony histologicznie lub cytologicznie rak p\u0142askonab\u0142onkowy g\u0142owy i szyi,\n\u2022\tstadium miejscowo zaawansowane lub nawracaj\u0105ca choroba niepodlegaj\u0105ce dost\u0119pnemu standardowemu leczeniu lub chemioimmunoterapii paliatywnej,\n\u2022\tco najmniej jedna zmiana targetowa dost\u0119pna do wstrzykni\u0119cia do guza, mniejsza ni\u017c 3 cm,\n\u2022\tbrak przerzut\u00f3w do m\u00f3zgu,\n\u2022\tstan sprawno\u015bci \u2014 ECOG 0-2,\n\u2022\twystarczaj\u0105ca wydolno\u015b\u0107 szpiku kostnego:\nWBC >= 3000/mm3 Hemoglobina > 10 g/dL (dozwolona transfuzja) Liczba p\u0142ytek >= 100 000/mm3,\n\u2022\tWystarczaj\u0105ca wydolno\u015b\u0107 w\u0105troby i nerek:\nBilirubina < 2-krotno\u015b\u0107 g\u00f3rnej granicy normy (GGN) AST/ALT =< 2,5 razy GGN, Kreatynina < 2,5 mg/dL,\n\u2022\tbrak niekontrolowanej objawowej zastoinowej niewydolno\u015bci serca i innych powa\u017cnych schorze\u0144 kardiologicznych,\n\u2022\tbrak choroby psychicznej lub sytuacji spo\u0142ecznej, kt\u00f3ra wyklucza\u0142aby zdolno\u015b\u0107 udzia\u0142u w badaniu,\n\u2022\tbrak niekontrolowanych ci\u0119\u017ckich schorze\u0144,\n\u2022\tbrak zaka\u017cenia wirusem HIV otrzymuj\u0105cych skojarzon\u0105 terapi\u0119 przeciwretrowirusow\u0105,\n\u2022\tbrak ci\u0105\u017cy oraz karmienia piersi\u0105,\n\u2022\tnegatywny test ci\u0105\u017cowy,\n\u2022\tstosowanie skutecznej antykoncepcji u chorych w wieku rozrodczym,\n\u2022\tponad 4 tygodnie od wcze\u015bniejszej radioterapii,\n\u2022\tponad 4 tygodnie od poprzedniej operacji.\n2. Monitorowanie przebiegu badania klinicznego fazy I u pacjent\u00f3w z rakiem g\u0142owy i szyi, z chorob\u0105 przetrwa\u0142\u0105 lub progresj\u0105 miejscow\u0105 po leczeniu chemioradioterapi\u0105 lub radioterapi\u0105 radykaln\u0105 bez obecno\u015bci odleg\u0142ych przerzut\u00f3w:\n1) Uczestnictwo przy doguzowym podaniu preparatu,\n2) \u0141\u0105cznie 12 pacjent\u00f3w: 4 grupy dawkowania po 3 pacjent\u00f3w: \na) min. 7 wizyt pacjent\u00f3w (badanie przesiewowe, 1 aplikacja preparatu kom\u00f3rkowego, +4 dni, 2 aplikacja preparatu kom\u00f3rkowego, +4 tygodnie, +12 tygodni, +24 tygodnie, ew. 2 dodatkowe aplikacje preparatu kom\u00f3rkowego (w maks. 7 dniowych odst\u0119pach)) \u2013 analiza bada\u0144 przedmiotowych, podmiotowych, bada\u0144 obrazowych, bada\u0144 laboratoryjnych,\nb) udzia\u0142 w 6-miesi\u0119cznym okres obserwacji prze\u017cycia wolnego od progresji,\nc) udzia\u0142 w 12-miesi\u0119cznej obserwacji ca\u0142kowitego czasu prze\u017cycia,\n3. Udzia\u0142 w ocenie guza po 4 dniach, nast\u0119pnie 4 tygodniach, 3 miesi\u0105cach (12 tygodni), 6 miesi\u0105cach (24 tygodnie) po rozpocz\u0119ciu leczenia pacjenta,\n4. Udzia\u0142 w potwierdzeniu pierwszej progresji za pomoc\u0105 kontrolnych bada\u0144 obrazowych (MRI) po co najmniej trzech miesi\u0105cach od pierwszego badania dokumentuj\u0105cego progresj\u0119 choroby (PD, ang. progressive disease).\n\nWyj\u0105tek: je\u015bli badacz zdecyduje si\u0119 rozpocz\u0105\u0107 alternatywne interwencje terapeutyczne.\n\nW okresie potwierdzenia leczenie mo\u017ce by\u0107 kontynuowane zgodnie z planem, je\u015bli pacjent, zgodnie z ocen\u0105 badacza, odnosi widoczne korzy\u015bci kliniczne przy minimalnej i akceptowalnej toksyczno\u015bci.\n\n5) Analiza oceny guza,\n6) Analiza oceny przep\u0142ywu krwi w obr\u0119bie guza,\n7) Kwalifikacja odpowiedzi guza zostanie jako odpowied\u017a ca\u0142kowita (CR, ang. Complete Response), odpowied\u017a cz\u0119\u015bciowa (PR, ang. Partial Response), choroba stabilna (SD, ang. Stable Disease) lub choroba post\u0119puj\u0105ca (PD),\n8) Monitorowanie prze\u017cycia dla ka\u017cdego pacjenta a\u017c do \u015bmierci lub przez co najmniej 12 miesi\u0119cy.\n\nZam\u00f3wienie obejmuje kompleksow\u0105 us\u0142ug\u0119 m.in. przygotowanie pe\u0142nej dokumentacji dla regulatora \nw celu uzyskania zezwolenia na prowadzenie badania klinicznego, przygotowanie pe\u0142nego protoko\u0142u badania klinicznego i SOP (standardowych procedur operacyjnych), przechowywanie dokumentacji itp.\n\nG\u0142\u00f3wnym celem badania jest ocena bezpiecze\u0144stwa podania preparatu kom\u00f3rkowego oraz ustalenie dawki zalecanej (RD, ang. recommended dose) dla fazy II, bior\u0105c pod uwag\u0119 g\u0142\u00f3wny punkt ko\u0144cowy: Wyst\u0119powanie toksyczno\u015bci limituj\u0105cej dawk\u0119 (DLT, ang. dose limiting toxicities).\n\nOstateczny zakres zapytania ofertowego b\u0119dzie uzale\u017cniony od rozwoju projektu \ni b\u0119dzie wynika\u0142 z aktualnych potrzeb Zamawiaj\u0105cego.\nZamawiaj\u0105cy zastrzega sobie mo\u017cliwo\u015b\u0107 realizacji zam\u00f3wienia w jakiejkolwiek cz\u0119\u015bci, \na Wykonawcy nie przys\u0142uguj\u0105 z tego tytu\u0142u \u017cadne roszczenia.\n\nThe subject of the order is:\nMonitoring of Phase I clinical trial.\n\nPlanned date of starting of the order: March 01, 2027.\n\nThe above-mentioned order consist of:\n1.\tRecruitment for the Phase I clinical trial.\nExemplary patient inclusion criteria:\n\u2022 histologically or cytologically confirmed squamous cell carcinoma of the head and neck,\n\u2022 locally advanced stage or recurrent disease not amenable to available standard treatment or palliative chemoimmunotherapy,\n\u2022 at least one target lesion available for injection into the tumor, less than 3 cm in size,\n\u2022 no brain metastases,\n\u2022 performance status \u2014 ECOG 0-2,\n\u2022 adequate bone marrow function:\nWBC >= 3000/mm3 Hemoglobin > 10 g/dL (transfusion allowed) Platelet count >= 100,000/mm3,\n\u2022 adequate liver and kidney function:\nBilirubin < 2 times the upper limit of normal (ULN) AST/ALT =< 2.5 times ULN, Creatinine < 2.5 mg/dL,\n\u2022 no uncontrolled symptomatic congestive heart failure and other serious cardiac diseases,\n\u2022 no mental illness or social situation that would exclude the ability to participate in the study,\n\u2022 no uncontrolled severe diseases,\n\u2022 no HIV infection receiving combined antiretroviral therapy,\n\u2022 no pregnancy and breastfeeding,\n\u2022 negative pregnancy test,\n\u2022 use of effective contraception in patients of reproductive age,\n\u2022 more than 4 weeks since the last radiotherapy,\n\u2022 more than 4 weeks since the previous surgery\n2.\tMonitoring the course of the Phase I clinical trial in patients with head and neck cancer, with persistent disease or local progression after treatment with chemoradiotherapy or radical radiotherapy without the presence of distant metastases:\n1)\tParticipation in intratumor administration of the cellular preparation,\n2)\t12 patients in total: 4 dose groups of 3 patients each:\na)\tmin. 7 patient visits (screening test, 1st application of a cell preparation, +4 days,\n2nd application of cell preparation, +4 weeks, +12 weeks, +24 weeks, possibly 2 additional applications of the cellular preparation (at max. 7-day intervals)) \u2013 performing physical and subjective examinations, imaging tests, laboratory tests,\nb)\tparticipation in the 6-month follow-up period for progression-free survival,\nc)\tparticipation in the 12-month follow-up of overall survival,\n\n3)\tParticipation in tumor assessment after 4 days, then after 4 weeks, 3 months (12 weeks), 6 months (24 weeks) after study treatment starts,\n\n4)\tParticipation in confirmation of the first progression using follow-up imaging (MRI) at least three months after the first examination documenting disease progression (PD),\n\nException: if the researcher decides to initiate alternative therapeutic interventions.\n\nDuring the confirmation period, treatment may continue as planned if the patient, in the investigator's judgment, demonstrates demonstrable clinical benefit with minimal and acceptable toxicity.\n\n5)\tAnalysis of tumor assessment,\n\n6)\tAnalysis of blood flow assessment within the tumor,\n\n7)\tQualifying tumor response as Complete Response (CR), PartiaI Response (PR), Stable Disease (SD) \nor Progressive Disease (PD),\n\n8)\tMonitoring survival for each patient until death or for a minimum of 12 months.\n\nThe order includes a comprehensive service among others preparation of full documentation for the regulator to obtain authorisation for the conducting a clinical trial, preparing a full clinical trial protocol and SOP (standard operating procedures), documentation storage etc.\n\nThe main aim of the study is to assess the safety of local administration of a cellular preparation \nin patients and to establish the recommended dose (RD) for phase II, taking into account the main endpoint: Occurrence of dose-limiting toxicity (DLT).\n\nThe final scope of the request for quotation will depend on the development of the project \nand will result from the current needs of the Ordering Party. \nThe Ordering Party reserves the right to complete the order in any part, and the Contractor is not entitled to any claims in this respect.","warranty_period":null,"cpv_items":[{"id":8513,"code":"73100000-3","name":"Us\u0142ugi badawcze i eksperymentalno-rozwojowe"}],"timetable_items":[],"fulfillment_places":[{"country":"Polska","voivodeship":null,"poviat":null,"commune":null,"locality":null,"created_by":null,"created_at":"2024-02-05 14:00:25","modified_at":"2024-02-05 14:00:25","modified_by":null,"id":496920,"type":{"id":2,"name":"ca\u0142a Polska"},"group_uuid":"f20e79f6-0641-445b-923d-8818599e3855"}],"participation_conditions":[{"id":1213168,"description":"Wykonawca musi posiada\u0107 niezb\u0119dne do\u015bwiadczenie tj.:\na) posiada\u0107 do\u015bwiadczon\u0105 kadr\u0119 wyspecjalizowan\u0105 co najmniej w obszarze onkologii oraz w prowadzeniu bada\u0144 klinicznych wczesnej fazy \u2013 I fazy lub First in Human \u2013 w ci\u0105gu ostatnich 3 lat \u2013 minimum 2 osoby\n\nContractors must have necessary experience ie.:\na) must have experienced staff specialized in at least the oncology area and in conducting early phase clinical trials - phase I or First in Human studies -in the recent 3 years \u2013 minimum 2 persons","type":{"id":2,"name":"Wiedza i do\u015bwiadczenie"},"created_by":null,"created_at":"2024-02-05 14:00:25","modified_at":"2024-02-05 14:00:25","modified_by":null,"group_uuid":"70028bec-04d7-4b38-bc6b-b5ae7c4530c7"},{"id":1213169,"description":"Wykonawca musi znajdowa\u0107 si\u0119 w sytuacji biznesowej i finansowej zapewniaj\u0105cej czasowe i zgodne \nz wymaganiami stawianymi w zapytaniu ofertowym wykonanie zam\u00f3wienia\n\nContractors must be in a business and financial situation that ensure timely and requirement compliant performance of the contract","type":{"id":5,"name":"Sytuacja ekonomiczna i finansowa"},"created_by":null,"created_at":"2024-02-05 14:00:25","modified_at":"2024-02-05 14:00:25","modified_by":null,"group_uuid":"b84d103e-2f23-4299-8f66-d1f9d5e95e2a"},{"id":1213170,"description":"Wykonawca musi zadeklarowa\u0107 gotowo\u015b\u0107 do przestrzegania protoko\u0142u badania, a tak\u017ce najnowszej wersji Deklaracji Helsi\u0144skiej, ICH-GCP oraz krajowych warunk\u00f3w prawnych i regulacyjnych\n\nContractors must declare readiness to comply with the study protocol, as well as the latest version of the Helsinki Declaration, ICH-GCP and national legal and regulatory conditions","type":{"id":7,"name":"Dodatkowe warunki udzia\u0142u"},"created_by":null,"created_at":"2024-02-05 14:00:25","modified_at":"2024-02-05 14:00:25","modified_by":null,"group_uuid":"4277bc4a-0956-4c62-9c12-66fb0b0be3b1"},{"id":1213171,"description":"Wykonawca nie mo\u017ce by\u0107 powi\u0105zany osobowo lub kapita\u0142owo z Zamawiaj\u0105cym.\nPrzez powi\u0105zania kapita\u0142owe lub osobowe rozumie si\u0119 wzajemne powi\u0105zania mi\u0119dzy beneficjentem \nlub osobami upowa\u017cnionymi do zaci\u0105gania zobowi\u0105za\u0144 w imieniu beneficjenta lub osobami wykonuj\u0105cymi w imieniu beneficjenta czynno\u015bci zwi\u0105zane z przeprowadzeniem procedury wyboru wykonawcy a wykonawc\u0105, polegaj\u0105ce w szczeg\u00f3lno\u015bci na:\na)\tuczestniczeniu w sp\u00f3\u0142ce jako wsp\u00f3lnik sp\u00f3\u0142ki cywilnej lub sp\u00f3\u0142ki osobowej,\nb)\tposiadaniu co najmniej 10% udzia\u0142\u00f3w lub akcji, o ile ni\u017cszy pr\u00f3g nie wynika z przepis\u00f3w prawa,\nc)\tpe\u0142nieniu funkcji cz\u0142onka organu nadzorczego lub zarz\u0105dzaj\u0105cego, prokurenta, pe\u0142nomocnika,\nd)\tpozostawaniu w zwi\u0105zku ma\u0142\u017ce\u0144skim, w stosunku pokrewie\u0144stwa lub powinowactwa w linii prostej, pokrewie\u0144stwa drugiego stopnia lub powinowactwa drugiego stopnia w linii bocznej \nlub w stosunku przysposobienia, opieki lub kurateli albo pozostawaniu we wsp\u00f3lnym po\u017cyciu \nz wykonawc\u0105, jego zast\u0119pc\u0105 prawnym lub cz\u0142onkami organ\u00f3w zarz\u0105dzaj\u0105cych lub organ\u00f3w nadzorczych wykonawc\u00f3w ubiegaj\u0105cych si\u0119 o udzielenie zam\u00f3wienia,\ne)\tpozostawaniu z wykonawc\u0105 w takim stosunku prawnym lub faktycznym, \u017ce istnieje uzasadniona w\u0105tpliwo\u015b\u0107 co do ich bezstronno\u015bci lub niezale\u017cno\u015bci w zwi\u0105zku z post\u0119powaniem o udzielenie zam\u00f3wienia\n\nThe Contractor may not be personally, or equity related to the Ordering Party.\nEquity or personal relationship is understood as relations between the Ordering Party or individuals authorized to take commitments on behalf of the Ordering Party or those acting on behalf of the Ordering Party in order to prepare and implement the contract award procedure, and the Contractor, including in particular:\na)\tBeing a partner to civil law partnership or commercial law partnership,\nb)\tHolding at least 10% of shares, if lower threshold does not result from law,\nc)\tBeing a member of a supervisory or management corporate body, a holder of general commercial power of attorney, an authorised representative,\nd)\tBeing married to, being in direct consanguinity or affinity, second degree consanguinity or affinity \nof the second degree collaterally or by adoption or guardianship or being in cohabitation with the Contractor, its legal representative or members of management or supervisory bodies of economic operators competing for the contract award,\ne)\tbeing in such a legal or factual relationship with the Contractor that there is a reasonable doubt as to their impartiality or independence in connection with the contract award procedure","type":{"id":4,"name":"Osoby zdolne do wykonania zam\u00f3wienia"},"created_by":null,"created_at":"2024-02-05 14:00:25","modified_at":"2024-02-05 14:00:25","modified_by":null,"group_uuid":"70a14fd1-ec67-44e5-adec-9d516be297fd"}],"category":{"id":1,"name":"Us\u0142uga"},"subcategory":{"id":4,"name":"Us\u0142ugi badawcze"},"created_by":null,"created_at":"2024-02-05 14:00:25","modified_at":"2024-02-05 14:00:25","modified_by":null,"group_uuid":"e7a9412c-b55f-4f52-ba95-4eb45b932f98"}],"evaluation_criteria":[{"id":675436,"price_criterion":true,"description":"\u2022\tCena \u2013 80 %\n\nKryterium \u201eCena\u201d oceniane b\u0119dzie w nast\u0119puj\u0105cy spos\u00f3b:\nPi(C) \u2013 liczba punkt\u00f3w jakie otrzyma oferta \u201ei\u201d za kryterium \u201eCena\u201d,\nCmin \u2013 najni\u017csza cena spo\u015br\u00f3d wszystkich wa\u017cnych i nieodrzuconych ofert,\nCi \u2013 cena oferty \u201ei\u201d.\nPi(C) = (Cmin : Ci) x 80\nW kryterium Oferent mo\u017ce uzyska\u0107 8 pkt","created_by":null,"created_at":"2024-02-05 14:00:25","modified_at":"2024-02-05 14:00:25","modified_by":null,"group_uuid":"35736952-30b8-43e8-9682-eccae142a597"},{"id":675437,"price_criterion":false,"description":"Kryterium \u201eDo\u015bwiadczenie personelu realizuj\u0105cego zlecenie\u201d\u201320%\n\u2022 Do\u015bwiadczenie w badaniach klinicznych terapii kom. oraz w badaniach klinicznych \nu pacjent\u00f3w z nowotworami g\u0142owy i szyi-20pkt\nDo\u015bwiadczenie w badaniach klinicznych terapii kom. lub u pacjent\u00f3w z nowotworami g\u0142owy i szyi-10pkt","created_by":null,"created_at":"2024-02-05 14:00:25","modified_at":"2024-02-05 14:00:25","modified_by":null,"group_uuid":"06235b3f-51a3-4d08-9179-8ea407392d6e"}],"is_variant":false,"title":"ZAPYTANIE OFERTOWE Nr 5/FENG-HAN/2024","order_node":{"id":296798},"created_by":null,"created_at":"2024-02-05 14:00:25","modified_at":"2024-02-05 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