{"status":"OK","data":{"advertisement":{"id":219322,"title":"MiniMax \u2013 pierwsza uniwersalna ch\u0142odzona elektroda do ablacji arytmii serca do nawigacji i mapowania tr\u00f3jwymiarowego serca bez promieniowania rentgenowskiego","partial_offer_allowed":false,"publication_date":"2023-07-19","submission_deadline":"2023-08-17 23:59:59","planned_sign_date":"2023-08-01","supplementary_orders":"Nie dotyczy.","terms_of_contract_change":"Zamawiaj\u0105cy zastrzega sobie mo\u017cliwo\u015b\u0107 dokonania istotnych zmian postanowie\u0144 zawartej umowy \nw stosunku do tre\u015bci oferty, na podstawie kt\u00f3rej dokonano wyboru Wykonawcy, w nast\u0119puj\u0105cym zakresie i sytuacjach:\n1)\tzmiany przepis\u00f3w prawa Unii Europejskiej lub prawa krajowego w zakresie maj\u0105cym wp\u0142yw na realizacj\u0119 Umowy (w szczeg\u00f3lno\u015bci zmiany stawek podatku VAT);\n2)\tzmiany terminu realizacji Umowy:\na)\tw przypadku wprowadzenia zmian w projekcie Zamawiaj\u0105cego, w tym w szczeg\u00f3lno\u015bci zmian dotycz\u0105cych termin\u00f3w wykonania badania klinicznego lub zmian wymagaj\u0105cych akceptacji NCBiR lub\nb)\tw przypadku zmian w protokole badania lub\nc)\tna skutek zmiany wymog\u00f3w, wytycznych, regulacji, decyzji lub instrukcji instytucji w\u0142a\u015bciwych do spraw rejestracji lub prowadzenia bada\u0144 klinicznych i rejestracji produkt\u00f3w leczniczych,\n3)\tzmiany w zakresie poszczeg\u00f3lnych element\u00f3w wchodz\u0105cych w sk\u0142ad przedmiotu Umowy, nieprowadz\u0105ce do zmiany charakteru Umowy \u2013 wynikaj\u0105ce ze zmian w przepisach prawa unijnego lub krajowego, wytycznych, decyzji, wymog\u00f3w, regulacji lub instrukcji instytucji w\u0142a\u015bciwych do spraw rejestracji lub prowadzenia bada\u0144 klinicznych i rejestracji produkt\u00f3w leczniczych, w sytuacji, \ngdy zmiany te s\u0105 niezb\u0119dne do prawid\u0142owego przygotowania, rejestracji lub przeprowadzenia badania klinicznego;\nZmiany Umowy wprowadzane b\u0119d\u0105 w formie aneksu podpisanego przez obie strony umowy, a mo\u017cliwo\u015b\u0107 ich wprowadzenia uzale\u017cniona jest od akceptacji przez Zamawiaj\u0105cego.","created_at":"2023-07-19 23:59:22","modified_at":"2023-08-18 00:00:04","contact_persons":[{"id":4440,"forename":"Agnieszka","surname":"Moskal","phone_number":"604161984","email":"agnieszka.moskal.kancelaria@amkradcaprawny.com","created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null},{"id":12510,"forename":"Marta ","surname":"Makuch","phone_number":"725500051","email":"marta.makuch@medinice.pl","created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null}],"orders":[{"id":359829,"estimated_value":null,"order_items":[{"id":406827,"description":"Przedmiotem zam\u00f3wienia jest wyb\u00f3r jednostki monitoruj\u0105cej badanie kliniczne (ang. Clinical Research Organization, CRO) wyrobu medycznego w zakresie testowania elektrody do ablacji serca. Zam\u00f3wienie obejmuje przygotowanie i przeprowadzenie przez CRO badania klinicznego wyrobu medycznego w zakresie testowania elektrody do ablacji serca. Celem badania klinicznego b\u0119dzie zbadanie bezpiecze\u0144stwa i skuteczno\u015bci dzia\u0142ania elektrody. Szczeg\u00f3\u0142owy opis przedmiotu zam\u00f3wienia zawarto w Zapytaniu ofertowym.","warranty_period":null,"cpv_items":[{"id":8512,"code":"73000000-2","name":"Us\u0142ugi badawcze i eksperymentalno-rozwojowe oraz pokrewne us\u0142ugi doradcze"}],"timetable_items":[],"fulfillment_places":[{"country":"Polska","voivodeship":"podkarpackie","poviat":"rzeszowski","commune":"Krasne","locality":"Krasne","created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null,"id":457395,"type":{"id":1,"name":"adres"},"group_uuid":"e03dd4fb-0e9e-4a3a-b313-d11999ee02c5"}],"participation_conditions":[{"id":1112054,"description":"Okre\u015blono w pkt 5 Zapytania ofertowego.","type":{"id":1,"name":"Uprawnienia do wykonywania okre\u015blonej dzia\u0142alno\u015bci lub czynno\u015bci"},"created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null,"group_uuid":"ff508fc1-a973-4d1b-990b-99f34f9a768e"},{"id":1112055,"description":"Okre\u015blono w pkt 5 Zapytania ofertowego.","type":{"id":2,"name":"Wiedza i do\u015bwiadczenie"},"created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null,"group_uuid":"b1fed0d7-a0d7-4e30-9627-ea31939d26cc"},{"id":1112056,"description":"Okre\u015blono w pkt 5 Zapytania ofertowego.","type":{"id":3,"name":"Potencja\u0142 techniczny"},"created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null,"group_uuid":"1bac80db-baf6-47c0-ad3e-051ba5cab6d3"},{"id":1112057,"description":"Okre\u015blono w pkt 5 Zapytania ofertowego.","type":{"id":4,"name":"Osoby zdolne do wykonania zam\u00f3wienia"},"created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null,"group_uuid":"da913753-9cdb-4e6f-8d79-1e6a18da0763"},{"id":1112058,"description":"Okre\u015blono w pkt 5 Zapytania ofertowego.","type":{"id":5,"name":"Sytuacja ekonomiczna i finansowa"},"created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null,"group_uuid":"b69920cf-b591-40ff-8a75-bed922c1fc3c"},{"id":1112059,"description":"Okre\u015blono w pkt 5 Zapytania ofertowego.","type":{"id":6,"name":"Lista wymaganych dokument\u00f3w/o\u015bwiadcze\u0144"},"created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null,"group_uuid":"c57c27cf-cea1-49b1-aa80-f37b422ba6c5"},{"id":1112060,"description":"Z post\u0119powania wykluczeni s\u0105 Wykonawcy powi\u0105zani z Zamawiaj\u0105cym osobowo lub\nkapita\u0142owo. Przez powi\u0105zania kapita\u0142owe lub osobowe rozumie si\u0119 wzajemne powi\u0105zania mi\u0119dzy Zamawiaj\u0105cym lub osobami upowa\u017cnionymi do zaci\u0105gania zobowi\u0105za\u0144 w mieniu Zamawiaj\u0105cego lub osobami wykonuj\u0105cymi w imieniu Zamawiaj\u0105cego czynno\u015bci zwi\u0105zane z przygotowaniem i przeprowadzaniem procedury wyboru wykonawcy, a wykonawc\u0105, polegaj\u0105ce w szczeg\u00f3lno\u015bci na:\n- uczestniczeniu w sp\u00f3\u0142ce jako wsp\u00f3lnik sp\u00f3\u0142ki cywilnej lub sp\u00f3\u0142ki osobowej,\n- posiadaniu co najmniej 10% udzia\u0142\u00f3w lub akcji,\n- pe\u0142nieniu funkcji cz\u0142onka organu nadzorczego lub zarz\u0105dzaj\u0105cego, prokurenta, pe\u0142nomocnika,\n- pozostawaniu 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 lub w stosunku przysposobienia, opieki lub kurateli.","type":{"id":7,"name":"Dodatkowe warunki udzia\u0142u"},"created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null,"group_uuid":"ad398702-9169-43e3-8b52-b43f8b7c704b"}],"category":{"id":1,"name":"Us\u0142uga"},"subcategory":{"id":4,"name":"Us\u0142ugi badawcze"},"created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null,"group_uuid":"48ed110a-74de-4b8b-b61a-669befc9e65f"}],"evaluation_criteria":[{"id":621154,"price_criterion":true,"description":"Cena (z\u0142) netto \u2013 waga: 50% (50 pkt) \nP1=CN/COB\u00d7[50%]\nP1 \u2013 liczba punkt\u00f3w przyznanych Oferentowi za zaoferowan\u0105 cen\u0119\nCN \u2013 najni\u017csza zaoferowana cena w post\u0119powaniu\nCOB \u2013 cena zaoferowana w ofercie badanej\nMo\u017cliwa do uzyskania (maksymalna) punktacja: 50 pkt.","created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null,"group_uuid":"3f7f5b10-e7b0-44ab-9284-7a9fceac1953"},{"id":621155,"price_criterion":false,"description":"Termin z\u0142o\u017cenia dokument\u00f3w wraz z wnioskiem o opini\u0119 w\u0142a\u015bciwej Komisji Bioetycznej\noraz wnioskiem o dopuszczenie i rozpocz\u0119cie badania klinicznego wyrobu medycznego do URPL po dostarczeniu przez Zamawiaj\u0105cego ostatnich dokument\u00f3w niezb\u0119dnych do z\u0142o\u017cenia wskazanych wniosk\u00f3w \u2013 waga: 25%, wg pkt 9.6.B.","created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null,"group_uuid":"e6bb815b-48f8-4a73-bf8a-91e3b766268a"},{"id":621156,"price_criterion":false,"description":"Termin dostarczenia ko\u0144cowego raportu CSR i TMF od dnia ostatniej wizyty ostatniego pacjenta \u2013 waga: 25% , wg wzoru okre\u015blonego w pkt 9.6.C Zapytania ofertowego.","created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null,"group_uuid":"fba2cb59-9b42-4f12-90fa-06958a12b2b2"}],"is_variant":false,"title":"Jednostka monitoruj\u0105ca do bada\u0144 klinicznych (CRO)","order_node":{"id":273394},"created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null}],"created_by":{"modified_by":null,"id":13255,"contact_persons":[]},"modified_by":{"modified_by":null,"id":1,"contact_persons":[]},"status":{"id":2,"label":"PUBLISHED","name":"Opublikowane"},"advertiser_address_details":{"name":"Medinice Sp\u00f3\u0142ka Akcyjna","identification_number_type":"nip","identification_number":"6631868308","address":{"country":"Polska","voivodeship":"mazowieckie","poviat":"Warszawa","commune":"Ochota","locality":"Warszawa","created_by":{"id":5141,"contact_persons":[{"id":4440,"forename":"Agnieszka","surname":"Moskal","phone_number":"604161984","email":"agnieszka.moskal.kancelaria@amkradcaprawny.com","created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null},{"id":12510,"forename":"Marta ","surname":"Makuch","phone_number":"725500051","email":"marta.makuch@medinice.pl","created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null}]},"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":{"id":5141,"contact_persons":[{"id":4440,"forename":"Agnieszka","surname":"Moskal","phone_number":"604161984","email":"agnieszka.moskal.kancelaria@amkradcaprawny.com","created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null},{"id":12510,"forename":"Marta ","surname":"Makuch","phone_number":"725500051","email":"marta.makuch@medinice.pl","created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null}]},"id":574061,"street":"Hankiewicza","number_description":"2","postcode":"02-103"},"created_by":{"id":5141,"contact_persons":[{"id":4440,"forename":"Agnieszka","surname":"Moskal","phone_number":"604161984","email":"agnieszka.moskal.kancelaria@amkradcaprawny.com","created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null},{"id":12510,"forename":"Marta ","surname":"Makuch","phone_number":"725500051","email":"marta.makuch@medinice.pl","created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null}]},"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":{"id":5141,"contact_persons":[{"id":4440,"forename":"Agnieszka","surname":"Moskal","phone_number":"604161984","email":"agnieszka.moskal.kancelaria@amkradcaprawny.com","created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null},{"id":12510,"forename":"Marta ","surname":"Makuch","phone_number":"725500051","email":"marta.makuch@medinice.pl","created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null}]},"id":219830},"advertisement":{"id":167049,"number":"2023-5141-167049","publication_date":"2023-07-18","created_by":{"modified_by":null,"id":13255,"contact_persons":[]},"created_at":"2023-07-18 17:54:12","modified_at":"2023-08-18 00:00:04","modified_by":{"modified_by":null,"id":1,"contact_persons":[]},"status":{"id":3,"label":"CLOSED","name":"Zamkni\u0119te"},"all_available_version_ids":[219091,219322],"enrollment":null,"projects":[{"id":4729,"name":"MiniMax - pierwsza uniwersalna ch\u0142odzona elektroda do ablacji arytmii serca do nawigacji i mapowania tr\u00f3jwymiarowego serca bez promieniowania rentgenowskiego.","number":"1065/17","activity":{"created_by":{"modified_by":null,"id":1,"contact_persons":[]},"created_at":"2020-08-17 19:00:00","modified_at":"2020-08-17 19:00:00","modified_by":{"modified_by":null,"id":1,"contact_persons":[]}},"region":{"created_by":{"modified_by":null,"id":1,"contact_persons":[]},"created_at":"2022-02-10 21:45:42","modified_at":"2022-02-10 21:45:42","modified_by":{"modified_by":null,"id":1,"contact_persons":[]}},"institution":null,"full_number":"POIR.01.01.01-00-1065/17","perspective":{},"programme":{"created_by":{"modified_by":null,"id":1,"contact_persons":[]},"created_at":"2020-08-17 19:00:00","modified_at":"2020-08-17 19:00:00","modified_by":{"modified_by":null,"id":1,"contact_persons":[]}},"priority":{"created_by":{"modified_by":null,"id":1,"contact_persons":[]},"created_at":"2020-08-17 19:00:00","modified_at":"2020-08-17 19:00:00","modified_by":{"modified_by":null,"id":1,"contact_persons":[]}},"type":"project","created_by":{"modified_by":null,"id":13255,"contact_persons":[]},"created_at":"2020-09-20 17:29:05","modified_at":"2020-09-20 17:29:05","modified_by":{"id":5141,"contact_persons":[{"id":4440,"forename":"Agnieszka","surname":"Moskal","phone_number":"604161984","email":"agnieszka.moskal.kancelaria@amkradcaprawny.com","created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null},{"id":12510,"forename":"Marta ","surname":"Makuch","phone_number":"725500051","email":"marta.makuch@medinice.pl","created_by":null,"created_at":"2023-07-19 23:59:22","modified_at":"2023-07-19 23:59:22","modified_by":null}]}}],"is_author":false,"is_admin":false},"attachments":[{"origin":{"id":219091,"publication_date":"2023-07-18"},"id":1076024,"name":"Zapytanie ofertowe_CRO_POIR/1/07/2023","file":{"id":1199121,"name":"Zapytanie ofertowe_CRO_2023 07 18.pdf","created_at":"2023-07-19 23:59:22","created_by":{"forename":"Agnieszka","surname":"Moskal"},"uri":"/api/files/1199121"},"group_uuid":"17a4fc02-ce1b-4c58-8eb7-fb9e4690b3f6"},{"origin":{"id":219091,"publication_date":"2023-07-18"},"id":1076025,"name":"Zal 1_Szczeg\u00f3\u0142owy formularz ofertowy","file":{"id":1199122,"name":"Zal 1_Szczegolowy formularz ofertowy_01072023.pdf","created_at":"2023-07-19 23:59:22","created_by":{"forename":"Agnieszka","surname":"Moskal"},"uri":"/api/files/1199122"},"group_uuid":"07b5c038-0bcc-4fd3-9a9f-11eddcfe2c2b"},{"origin":{"id":219091,"publication_date":"2023-07-18"},"id":1076026,"name":"Za\u0142 2_Osw_spe\u0142nienie warunk\u00f3w post\u0119powania","file":{"id":1199123,"name":"Zal 2_Osw_spelnienie warunkow postepowania_01072023.pdf","created_at":"2023-07-19 23:59:22","created_by":{"forename":"Agnieszka","surname":"Moskal"},"uri":"/api/files/1199123"},"group_uuid":"156d66b8-bbe4-48a8-9219-aad96522c9aa"},{"origin":{"id":219091,"publication_date":"2023-07-18"},"id":1076027,"name":"Za\u0142 3_Oswiadczenie o braku powi\u0105za\u0144","file":{"id":1199124,"name":"Zal 3_Osw o braku powiazan_01072023.pdf","created_at":"2023-07-19 23:59:22","created_by":{"forename":"Agnieszka","surname":"Moskal"},"uri":"/api/files/1199124"},"group_uuid":"b7b5e41b-214e-474c-818d-572aafc12535"},{"origin":{"id":219091,"publication_date":"2023-07-18"},"id":1076028,"name":"Za\u0142 4_umowa o zachowaniu poufno\u015bci","file":{"id":1199126,"name":"Zal 4_umowa o poufnosci_01072023.pdf","created_at":"2023-07-19 23:59:22","created_by":{"forename":"Agnieszka","surname":"Moskal"},"uri":"/api/files/1199126"},"group_uuid":"646d7e6a-aace-420c-a381-1ce61b0416e3"},{"origin":{"id":219322,"publication_date":"2023-07-19"},"id":1077678,"name":"2023.07.19_Zapytanie ofertowe","file":{"id":1200953,"name":"Zapytanie ofertowe_CRO_2023 07 19.pdf","created_at":"2023-07-19 23:58:58","created_by":{"forename":"Agnieszka","surname":"Moskal"},"uri":"/api/files/1200953"},"group_uuid":"07b8303a-4573-4f8f-aa1f-38331d363f4f"},{"origin":{"id":219322,"publication_date":"2023-07-19"},"id":1077679,"name":"2023.07.19_Opis zmian","file":{"id":1200954,"name":"2023.07.19_Opis zmian.pdf","created_at":"2023-07-19 23:59:13","created_by":{"forename":"Agnieszka","surname":"Moskal"},"uri":"/api/files/1200954"},"group_uuid":"a04878ce-1188-44f5-aa69-a13d6bc7e3af"}]},"dictionaries":{"announcement_status_draft":1,"announcement_status_published":2},"favorite":null,"badge":null,"offer_set_badge_count":null,"question_badge_count":null}}