{"status":"OK","data":{"advertisement":{"id":242387,"title":"ZAPYTANIE OFERTOWE Nr 5/FENG-PAN/2024","partial_offer_allowed":false,"publication_date":"2024-02-02","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":"2024-02-02 16:44:44","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":393107,"estimated_value":null,"order_items":[{"id":443251,"description":"Monitorowanie badania klinicznego fazy I.\n\nPlanowana data rozpocz\u0119cia realizacji zam\u00f3wienia: 1.07.2027 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:\n\u2022\twiek \u2265 18 lat;\n\u2022\thistologicznie potwierdzony rak trzustki, ze wznow\u0105 po terapii FOLFIRINOX, bez przerzut\u00f3w do m\u00f3zgu;\n\u2022\tobecno\u015b\u0107 co najmniej jednej zmiany mierzalnej za pomoc\u0105 CT lub MRI, o najd\u0142u\u017cszym wymiarze 10 mm w MRI;\n\u2022\twsp\u00f3\u0142czynnik Karnofskiego (KPS) \u2265 70%;\n\u2022\tudokumentowany negatywny wynik testu na HIV, HBV, HCV (brak infekcji).\n2. Monitorowanie Bada\u0144 Klinicznych - I faza bada\u0144 klinicznych - Pacjenci z PDAC z nawrotem po leczeniu pierwszego rzutu FOLFIRINOX bez przerzut\u00f3w do m\u00f3zgu.\n\nPrzebieg studi\u00f3w:\n\na) Podawanie dootrzewnowe lub doguzowe (MDC-PAN) przez cewnik dootrzewnowy (np. Braun, Celsite Dreinaport) w po\u0142\u0105czeniu z do\u017cyln\u0105 gemcytabin\u0105 w szpitalu,\n\nb) \u0141\u0105cznie 12 pacjent\u00f3w: 4 grupy dawek po 3 pacjent\u00f3w ka\u017cda:\n\u2022 minimum 7 wizyt pacjenta (badanie przesiewowe, 1 aplikacja leku kom\u00f3rkowego + gemcytabina do\u017cylnie, +4 dni, 2 aplikacja leku kom\u00f3rkowego + gemcytabina do\u017cylnie, +4 tygodnie, +12 tygodni, +24 tygodnie, ewentualnie 2 dodatkowe podania leku kom\u00f3rkowego + gemcytabina do\u017cylnie (w odst\u0119pach maksymalnie 7-dniowych) \u2013 analiza bada\u0144 przedmiotowych i subiektywnych, bada\u0144 obrazowych, bada\u0144 laboratoryjnych,\n\u2022 udzia\u0142 w 6-miesi\u0119cznym okresie obserwacji pod k\u0105tem prze\u017cycia wolnego od progresji,\n\u2022 udzia\u0142 w 12-miesi\u0119cznej obserwacji prze\u017cycia ca\u0142kowitego,\n\u2022 udzia\u0142 w ocenie guza po 4 dniach, 4 tygodniach, 3 miesi\u0105cach (12 tygodni), 6 miesi\u0105cach (24 tygodniach) od rozpocz\u0119cia leczenia w ramach badania,\n\u2022 udzia\u0142 w potwierdzeniu pierwszej progresji za pomoc\u0105 obrazowania kontrolnego (MRI) co najmniej 3 miesi\u0105ce od pierwszego badania dokumentuj\u0105cego post\u0119puj\u0105c\u0105 chorob\u0119 (PD) (chyba, \u017ce badacz zdecyduje si\u0119 na podj\u0119cie alternatywnych interwencji terapeutycznych),\n\nW okresie potwierdzenia leczenie mo\u017cna kontynuowa\u0107 zgodnie z planem, je\u015bli w ocenie badacza pacjent wyka\u017ce mo\u017cliwe do wykazania korzy\u015bci kliniczne przy minimalnej i akceptowalnej toksyczno\u015bci.\n\n\u2022 analiza oceny nowotworu wed\u0142ug RECIST w. 1.1. lub kryteria iRECIST,\n\u2022 analiza oceny przep\u0142ywu krwi w obr\u0119bie guza metod\u0105 angio-TK,\n\u2022 kwalifikuj\u0105ca odpowied\u017a nowotworu jako odpowied\u017a ca\u0142kowita (CR), odpowied\u017a cz\u0119\u015bciowa (PR), choroba stabilna (SD) lub choroba post\u0119puj\u0105ca (PD),\n\u2022 monitorowanie aktualizacji prze\u017cycia ka\u017cdego pacjenta a\u017c do \u015bmierci lub przez minimum 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\n\nThe subject of the order is:\nMonitoring of Phase I clinical trial.\n\nPlanned date of starting of the order: July 01, 2027.\n\nThe above-mentioned order consist of:\n1.\tRecruitment for the Phase I clinical trial.\nExamples of inclusion criteria:\n\u2022\tage \u2265 18 years;\n\u2022\thistologically confirmed pancreatic cancer, with recurrence after FOLFIRINOX therapy, without brain metastases;\n\u2022\tthe presence of at least one lesion measurable by CT or MRI with the longest dimension of 10 mm on MRI; \n\u2022\tKarnofsky coefficient (KPS) \u2265 70%;\n\u2022\tdocumented negative test result for HIV, HBV, HCV (no infection).\n\n\n2. Clinical Trial Monitoring - Phase I of clinical trials - PDAC patients with recurrence after first-line treatment with FOLFIRINOX without brain metastases.\n\nThe course of the study:\n\na) Intraperitoneal or intratumoral administration (MDC-PAN) via an intraperitoneal catheter (e.g. Braun, Celsite Drainaport) in combination with intravenous gemcitabine in hospital,\n\nb) 12 patients in total: 4 dose groups of 3 patients each:\n\u2022\tminimum 7 patient visits (screening test, 1 application of the cell drug product + gemcitabine intravenously, +4 days, 2nd application of the cell drug product + gemcitabine intravenously, +4 weeks, +12 weeks, +24 weeks, possibly 2 additional applications of the cell drug product + gemcitabine intravenously (at max. 7-day intervals) \u2013 analysis of physical and subjective examinations, imaging tests, laboratory tests,\n\u2022\tparticipation in 6-month follow-up period for progression-free survival,\n\u2022\tparticipation in 12-month follow-up of overall survival,\n\u2022\tparticipation in tumor assessment at 4 days, 4 weeks, 3 months (12 weeks), 6 months (24 weeks) after study treatment starts,\n\u2022\tparticipation in confirmation of the first progression using follow-up imaging (MRI) at least three months after the first examination documenting progressive disease (PD) (unless the researcher selects 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 \ntoxicity.\n\n\u2022\tanalysis of assessing tumor evaluation according to RECIST w. 1.1. or iRECIST criteria,\n\u2022\tanalysis of assessing blood flow within the tumor using angio-TK,\n\u2022\tqualifying tumor response as Complete Response (CR), PartiaI Response (PR), Stable Disease (SD)or Progressive Disease (PD),\n\u2022\tsurvival update monitoring for each patient until death or for a minimum of 12 months.\n\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 the cell drug product in patients with pancreatic cancer during the first recurrence and to establish the recommended dose (RD) for phase II, considering 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, \nand the Contractor is not entitled to any claims in this respect\n","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":"2024-02-02 16:44:44","modified_at":"2024-02-02 16:44:44","modified_by":null,"id":496710,"type":{"id":2,"name":"ca\u0142a Polska"},"group_uuid":"75c4599f-9bac-45e7-8d34-a2a6be75b2c9"}],"participation_conditions":[{"id":1212695,"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 - in the recent 3 years \u2013 minimum 2 persons","type":{"id":2,"name":"Wiedza i do\u015bwiadczenie"},"created_by":null,"created_at":"2024-02-02 16:44:44","modified_at":"2024-02-02 16:44:44","modified_by":null,"group_uuid":"a3e320fa-0b91-4451-b870-857374e15335"},{"id":1212696,"description":"Wykonawca musi znajdowa\u0107 si\u0119 w sytuacji biznesowej i finansowej zapewniaj\u0105cej czasowe i zgodne z 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":"2024-02-02 16:44:44","modified_at":"2024-02-02 16:44:44","modified_by":null,"group_uuid":"9df18d9a-ad76-49af-890d-114f6b575348"},{"id":1212697,"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\nContractor 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":"2024-02-02 16:44:44","modified_at":"2024-02-02 16:44:44","modified_by":null,"group_uuid":"bf017e75-cbf2-4cad-b5d7-1b9724486176"},{"id":1212698,"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":"2024-02-02 16:44:44","modified_at":"2024-02-02 16:44:44","modified_by":null,"group_uuid":"38ed2dc9-c708-474f-9556-a836e774e647"}],"category":{"id":1,"name":"Us\u0142uga"},"subcategory":{"id":4,"name":"Us\u0142ugi badawcze"},"created_by":null,"created_at":"2024-02-02 16:44:44","modified_at":"2024-02-02 16:44:44","modified_by":null,"group_uuid":"f52a32d7-d8b1-4601-8346-2a7c8a0c3b00"}],"evaluation_criteria":[{"id":675009,"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 80 pkt","created_by":null,"created_at":"2024-02-02 16:44:44","modified_at":"2024-02-02 16:44:44","modified_by":null,"group_uuid":"537e7c86-5f46-426a-a1aa-5347ac2d60c5"},{"id":675010,"price_criterion":false,"description":"Kryterium \u201eDo\u015bwiadczenie personelu realizuj\u0105cego zlecenie\u201d \u2013 20%:\n\u2022 Do\u015bwiadczenie w badaniach klinicznych terapii kom. oraz w badaniach klinicznych u pacjent\u00f3w z nowotworami trzustki\u201320 pkt\n\u2022 Do\u015bwiadczenie w badaniach klinicznych terapii kom. lub u pacjent\u00f3w z rakiem trzustki-10 pkt","created_by":null,"created_at":"2024-02-02 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