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Clinical research services for the development and execution of a Phase 1 safety and acceptability study

Data publikacji: 19.06.2018

Informacje o ogłoszeniu

Termin składania ofert

do dnia 10-09-2018

Numer ogłoszenia

1119826

Status ogłoszenia

Zakończone

Treść ogłoszenia została zmieniona

From 18.06.2018 K2Biomedical sp. z o.o. has changed the name of the company for Orion Biotechnology Polska sp. z o.o.
The answers to questions have been published.
Wydłużenie terminu złożenia oferty z 20.07.2018 do 31.08.2018/ The deadline for offer submission is changed from 20th July to 31st August 2018.
Wydłużenie terminu złożenia oferty z 31.08.2018 do 10.09.2018/ The deadline for offer submission is changed from 31st August to 10th September 2018.

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 10th September 2018:
Orion Biotechnology Polska sp. z o.o. ul. Bobrzyńskiego 14, 30-348 Kraków, POLAND
2. Tender evaluation shall be made till September 21st, 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

Orion Biotechnology Polska is seeking a CRO to develop their OB-002H protein as a microbicide gel formulation product for the prevention of HIV. Preclinical toxicology programs and GLP/GMP manufacturing work is currently underway. Orion Polska requests a proposal to cover work associated with all necessary clinical trial services formulation to support a first-in-human Phase 1 clinical trial.

The chosen CRO should outline in their proposal a development plan to conduct the following activities:
1) Study setup and familiarization
2) Overall project management and team meetings
3) Identification and evaluation of a Phase 1 study unit and subsequent budgets (location: Poland)
4) Site and Study Team budgeting and payments
5) Patients costs reimbursement
6) Identification and evaluation of central laboratory services
7) Medical Writing (including but not limited to Study Protocol, Patients Information and Informed Consent Form (ICF), Case Report Form (CRF), final Clinical Study Report)
8) Study Drug Management
9) Randomization processing
10) Safety monitoring (safety plan/guideline for the site; AE/SAE monitoring and management, medical management coverage 24/7/365; safety data analyses, medical coding, SUSAR preceding and distribution, DSUR and PSUR reporting and processing) 11) Study related regulatory procedures
12) Study initiation and site management
13) Recruitment and clinical monitoring
14) Study and site close-out
15) Data management activities
16) Statistical analysis plans (including Interim Analysis Plan)
17) Estimation of all expected past through costs (including insurance, RA and EC fee for main approval and potential amendments, patents fee, Patients and CRA traveling costs, external lab costs, shipments costs if apply, meetings and other if any – then please specify)

Additional activities and sub-activities may be added upon the discretion of Orion Biotechnology Polska sp. z o.o. or through suggestion by CRO.

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 develop their OB-002H protein as a microbicide gel formulation product for the prevention of HIV. Preclinical toxicology programs and GLP/GMP manufacturing work is currently underway. Orion Polska requests a proposal to cover work associated with all necessary clinical trial services formulation to support a first-in-human Phase 1 clinical trial.

Przedmiot zamówienia

The chosen CRO should outline in their proposal a development plan to conduct the following activities:
1) Study setup and familiarization
2) Overall project management and team meetings
3) Identification and evaluation of a Phase 1 study unit and subsequent budgets (location: Poland)
4) Site and Study Team budgeting and payments
5) Patients costs reimbursement
6) Identification and evaluation of central laboratory services
7) Medical Writing (including but not limited to Study Protocol, Patients Information and Informed Consent Form (ICF), Case Report Form (CRF), final Clinical Study Report)
8) Study Drug Management
9) Randomization processing
10) Safety monitoring (safety plan/guideline for the site; AE/SAE monitoring and management, medical management coverage 24/7/365; safety data analyses, medical coding, SUSAR preceding and distribution, DSUR and PSUR reporting and processing) 11) Study related regulatory procedures
12) Study initiation and site management
13) Recruitment and clinical monitoring
14) Study and site close-out
15) Data management activities
16) Statistical analysis plans (including Interim Analysis Plan)
17) Estimation of all expected past through costs (including insurance, RA and EC fee for main approval and potential amendments, patents fee, Patients and CRA traveling costs, external lab costs, shipments costs if apply, meetings and other if any – then please specify)

Kod CPV

73100000-3

Nazwa kodu CPV

Usługi badawcze i eksperymentalno-rozwojowe

Dodatkowe przedmioty zamówienia

Not applicable

Harmonogram realizacji zamówienia

Deadline for completion of the subject of the order: up to 18 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

Uprawnienia do wykonywania określonej działalności lub czynności

Yes

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 by signing an annex

Lista dokumentów/oświadczeń wymaganych od Wykonawcy

Contractor must prepare the tender offer in English or Polish on the attached offer form (Attachment No 2) based on detailed calculation (using template Attachment No 3). Both documents should be sent to Orion Biotechnology Polska Sp. z o.o.

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 experience and successful track record in conducting a minimum of 5 clinical trials, including a minimum of 2 with biological substances.
3. Documented quality control system (SOP - Standard Operations Procedures).
4. Possession of human resources (minimum 2 experienced clinical trial monitors with a minimum of 2.5 years of experience in the CRA position (Senior CRA).
5. Documented experience and professional history in the field of projects related to the European Medicines Agency (EMA) and the Federal Administration of Food and Drug Administration (FDA).
6. Program completion within Orion Biotechnology Poland’s required timeframe.

The entry criteria (1-6) must be met by the bidder. Only in this case will be evaluated based on price criterion.

The ordering party may request additional information from the bidder during the analysis of offers or supplements, if the information included in the offer will not allow an objective assessment of the offer.

Method of assessment: The ordering party will select the offer with the lowest price among the offers complying with the requirements of the proceedings.

The ordering party may decide to conduct the negotiation process with selected, based on entry/basic requirements, representatives of contractors.

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

Inne źródła finansowania

Not applicable

Informacja o wybranym wykonawcy

Rozstrzygnięte

Nazwa i adres, data wpłynięcia oferty oraz jej cena

Nazwa: Scope International AG
Adres: Konrad - Zuse - Ring 18, 68163 Mannheim, Germany
Data wpłynięcia: 10.09.2018
Cena: 2 164 842,83 PLN
Liczba wyświetleń: 352