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GLP bioanalytics for serum samples derived from preclinical animal toxicology studies

Data publikacji: 04.09.2018

Informacje o ogłoszeniu

Termin składania ofert

do dnia 11-09-2018

Numer ogłoszenia

1134987

Status ogłoszenia

Zakończone

Treść ogłoszenia została zmieniona

From 18.05.2018 Orion Biotechnology Polska Sp. z o.o.

Miejsce i sposób składania ofert

1. The tender should be sent by email to: beata.b@orionbiotechnology.com, by post, by courier or delivered personally to the address by September 11th, 2018 at 12:00PM:
Orion Biotechnology Polska sp. z o.o. ul. Bobrzyńskiego 14, 30-348 Kraków, POLAND
2. Tender evaluation shall be made September 13th 2018 and the results and choice of the most favorable tender will be announced on the website at http://www.bazakonkurencyjnosci.funduszeeuropejskie.gov.pl
3. Tenders submitted after deadline shall not be examined.
4. Contractor may amend or withdraw the tender offer before the deadline.
5. In the course of examination and tenders evaluation Purchaser may request from Contractors explanations concerning the content of submitted tenders.
6. Enquiry for quotation has been placed on following websites: http://www.bazakonkurencyjnosci.funduszeeuropejskie.gov.pl

Adres e-mail, na który należy wysłać ofertę

beata.b@orionbiotechnology.com

Osoba do kontaktu w sprawie ogłoszenia

Jarret Engstrom

Skrócony opis przedmiotu zamówienia

OVERALL SCOPE
Orion Biotechnology Polska is seeking a CRO to process and analyze samples collected from preclinical GLP toxicology animal studies, which were conducted utilizing the company’s OB-002H protein as a microbicide gel formulation product. A total of four GLP toxicology studies in rat and rabbit models were performed to characterize the toxicokinetics and toxicity of OB-002H. The following sample numbers were collected from these studies:
1. Rat (rectal administration) – 252 serum samples
2. Rat (vaginal administration) – 96 serum samples
3. Rabbit (rectal administration) – 252 serum samples
4. Rabbit (vaginal administration) – 260 serum samples

CRO should assume all samples will be analyzed. Analysis of serum samples will be performed using pre-developed methods and validated assay.

More detailed information about methods and assays to be performed will be provided upon e-mail request to: beata.b@orionbiotechnology.com

TIMELINES & BUDGET
Contractor will assign a lead contact within contractor organization that will be Orion Poland’s main technical contact for communication and to ensure adherence to mutually agreeable timelines and budgets.

Kategoria ogłoszenia

Usługi

Podkategoria ogłoszenia

Usługi badawcze

Miejsce realizacji zamówienia

Województwo: małopolskie Powiat: Kraków Miejscowość: Kraków

Opis przedmiotu zamówienia

Cel zamówienia

Orion Biotechnology Polska is seeking a CRO to process and analyze samples collected from preclinical GLP toxicology animal studies, which were conducted utilizing the company’s OB-002H protein as a microbicide gel formulation product. A total of four GLP toxicology studies in rat and rabbit models were performed to characterize the toxicokinetics and toxicity of OB-002H. The following sample numbers were collected from these studies:
1. Rat (rectal administration) – 252 serum samples
2. Rat (vaginal administration) – 96 serum samples
3. Rabbit (rectal administration) – 252 serum samples
4. Rabbit (vaginal administration) – 260 serum samples

CRO should assume all samples will be analyzed. Analysis of serum samples will be performed using pre-developed methods and validated assay.

More detailed information about methods and assays to be performed will be provided upon e-mail request to: beata.b@orionbiotechnology.com

Przedmiot zamówienia

Orion Biotechnology Polska is seeking a CRO to process and analyze samples collected from preclinical GLP toxicology animal studies, which were conducted utilizing the company’s OB-002H protein as a microbicide gel formulation product. A total of four GLP toxicology studies in rat and rabbit models were performed to characterize the toxicokinetics and toxicity of OB-002H. The following sample numbers were collected from these studies:
1. Rat (rectal administration) – 252 serum samples
2. Rat (vaginal administration) – 96 serum samples
3. Rabbit (rectal administration) – 252 serum samples
4. Rabbit (vaginal administration) – 260 serum samples

CRO should assume all samples will be analyzed. Analysis of serum samples will be performed using pre-developed methods and validated assay.

More detailed information about methods and assays to be performed will be provided upon e-mail request to: beata.b@orionbiotechnology.com

Kod CPV

73100000-3

Nazwa kodu CPV

Usługi badawcze i eksperymentalno-rozwojowe

Dodatkowe przedmioty zamówienia

The Ordering Party reserves the option of awarding a supplementary order to the selected contractor in the result of the procedure, in a quantity not exceeding 50% of the quantity specified in this request for proposal. The subject of supplementary order will be consistent with the subject of the basic contract.

Harmonogram realizacji zamówienia

Deadline for completion of the subject of the order: up to 2 months or shorter from fulfilment of the below conditions by Purchaser:
1. Receipt of subsidy from structural funds of the European Union within Sectoral Programme InnoNeuroPharm, Priority Axis I: Supporting R&D carried out by enterprises, Measure 1.2: Sectoral R&D Programmes of Intelligent Development Operational Programme for the period 2014-2020 for the project by Purchaser.
2. NCBiR will not object against hiring Contractor.

Załączniki

Pytania i wyjaśnienia

Brak pytań i wyjaśnień

Uprawnienia do wykonywania określonej działalności lub czynności

Purchaser shall evaluate valid tenders on the basis of the following criteria:
Entry criteria/basic requirements (YES/NO):
1. Accuracy to requested subject of order (Section II).
2. Documented, relevant company capabilities and infrastructure to fulfill project needs (see Offer Form – Attachments).
3. Program completion within Orion Biotechnology Poland’s required timeframe.

The entry criteria (1-3) must be met by the bidder. Only in this case will be evaluated based on price criterion.
Method of assessment:
The ordering party will select the offer with the lowest price among the offers complying with the requirements of the proceedings.

Wiedza i doświadczenie

Yes

Potencjał techniczny

Yes

Osoby zdolne do wykonania zamówienia

Yes

Sytuacja ekonomiczna i finansowa

Not applicable

Dodatkowe warunki

Not applicable

Warunki zmiany umowy

Only in a written way (by an annex signature)

Lista dokumentów/oświadczeń wymaganych od Wykonawcy

Contractor must prepare the tender offer in English or Polish on the attached offer form (Attachment No 1).
The offer must:
• Include the full name of a Contractor and contact details;
• Include date of the offer/submission date (In the absence of the date of issue on the tenders submitted by e-mail, date of receipt will be equivalent to the issue of the offer).
• Include price for order (without VAT/TAX). The Ordering Party accepts the tenders with prices given in different currency, however, for the purposes of comparison the tender price will be converted into PLN using current exchange rates at the time of tender (Average Exchange Rate Table of the National Bank of Poland (NBP): http://www.nbp.pl/). To avoid any doubts, the tender prices in PLN will be used only for comparing the tenders and for awarding scores; all settlements with the Contractor will be in the currency of the offer.
• Include Vendor’s certification’s and portfolio of highlighted experience in the field of clinical trial programs set out in clause VII;
• Describe all additional elements required for tender;
• Estimated date of completion of the contract;
• RFQ expiration date specified – at least 90 calendar days from the RFQ end date to enable
Service Agreement finalization;
• Be legibly signed by the Contractor.

A lack of any of the above mentioned items will result in rejection of the tender for formal reasons.

Zamówienia uzupełniające

The Ordering Party reserves the option of awarding a supplementary order to the selected contractor in the result of the procedure, in a quantity not exceeding 50% of the quantity specified in this request for proposal. The subject of supplementary order will be consistent with the subject of the basic contract.

Ocena oferty

Kryteria oceny i opis sposobu przyznawania punktacji

Purchaser shall evaluate valid tenders on the basis of the following criteria:
Entry criteria/basic requirements (YES/NO):
1. Accuracy to requested subject of order (Section II).
2. Documented, relevant company capabilities and infrastructure to fulfill project needs (see Offer Form – Attachments).
3. Program completion within Orion Biotechnology Poland’s required timeframe.

The entry criteria (1-3) must be met by the bidder. Only in this case will be evaluated based on price criterion.
Method of assessment:
The ordering party will select the offer with the lowest price among the offers complying with the requirements of the proceedings.

Wykluczenia

Equity or personal relationship

Zamawiający - Beneficjent

Nazwa

K2 BIOMEDICAL SP. Z O.O.

Adres

prof. Michała Bobrzyńskiego 14

30-348 Kraków

małopolskie , Kraków

Numer telefonu

694413749

NIP

6762495612

Tytuł projektu

Opracowanie nowego kandydata na lek mikrobójczy zapobiegający przenoszeniu wirusa HIV

Numer projektu

POIR.01.02.00-00-0003/17-00

Informacja o wybranym wykonawcy

Rozstrzygnięte

Nazwa i adres, data wpłynięcia oferty oraz jej cena

Nazwa: Envigo CRS Limited
Adres: Wooley Road, Alconbury, Huntingdon Cambhdgeshire PE28 4H5 UK
Data wpłynięcia: 11.09.2018
Cena: 100 550 GBP
Liczba wyświetleń: 69