Warsaw, 13.09.2017
REQUEST FOR PROPOSALS No. 02/09/2017
Due to the fact that the Ordering Party is planning to submit an EU grant proposal within sub-measure 1.1.1. of Intelligent Development Operational Programme organised by the National Center of Research and Development (industrial research and development works of entrepreneurs) and also due to the fact that purchase of goods and services must be conducted based on most favourable economic proposal in line with fair competition, effectiveness and transparency, Pharmajd Sp. z o.o. hereby presents the request for tenders.
- ORDERING PARTY:
Pharmajd spółka z ograniczoną odpowiedzialnością
Al. Jerozolimskie 101/11
02-011 Warszawa
Tel.: +48 22 370 28 66
Website:
Hereinafter also: Ordering party or Pharmajd
- CONTACTING AWARDING PROCEDURE:
II.1.This contact shall not be subject to the provisions of the Act of 29 January 2004 Public Procurement Law (Journal of Laws of 2007 No. 223, item 1655, as amended)
II.2.The request for tender is prepared according to the principle of competitiveness.
II.3.This contact awarding procedure shall be held in compliance with the principle of competitiveness, disclosure, transparency and equal treatment.
II.4.The ordering party will ensure to avoid conflicts of interest such as lack of objectiveness or lack of neutrality.
II.5.This contract shall be awarded in accordance with the contract-awarding regulations applicable by the ORDERING PARTY.
II.6.The contract-awarding regulations shall be available at the ORDERING PARTY’s office (Al. Jerozolimskie 101/11, 02-011 Warszawa).
II.7.The ORDERING PARTY shall reserve the right to cancel the procedure at any stage without stating the reason.
II.8.Amendments shall be notified by the ORDERING PARTY to the BIDDERS and shall be posted on the Company’s website and premises.
II.9.The ORDERING PARTY shall reserve the right to request additional information, documents or clarifications.
II.10.This request for proposals shall not oblige ORDERING PARTY to award a contract.
II.11.In the event of selecting a winning proposal or cancellation of the request for tenders the ordering party will inform the bidders and shall publish a relevant information on the website.
II.12.In case the ordering party receives the EU grant for the subject of the tender, the request for tender along with attachments will be visualized according to the provisions of the grant agreement.
II.13.By submitting a proposala bidding party acknowledges and fully accepts the text and the principles of the request for tenders.
II.14.As part of this request for proposals, ORDERING PARTY shall not allow partial proposals.
II.15.As part of this request for proposals, ORDERING PARTY shall not allow partial contracts.
- DETAILS OF THE SUBJECT MATTER OF THE CONTRACT:
CPV code:73110000-6 Research Services
The subject matter of the request for proposals:
Performance of a randomized multicenter controlled Phase IIa clinical trial on a novel pharmaceutical topical gel for wound healing.
A. The trial shall be performed on 100 subjects with chronic diabetic foot ulcers (DFU) in 15 different sites (in 3 countries).
B.The trial shall be subject to monitoring:
-Total Number of Pre-Study Visits (PSVs) - 20 visit(s)
-Total Number of Site Initiation Visits (SIVs) - 15 visit(s)
-Average Number of Monitoring Visits (MVs) per Site - 4 visit(s)
-Total Number of Monitoring Visits (MVs) - 60 visit(s)
-Total Number of Site Close-out Visits- 15 visit(s)
C.Safety information expected by the ordering party
-Total Number of Serious Adverse Events (SAE)- 5
-Total Number of SUSARs- 2
-Total Number of DSURs- 2
D. Protocol duration – 24 weeks (4weeks run-in and up to 20 weeks of treatment)
E. Recruitment period – 6 months
F. Start-up duration – 6 months
G. Study duration on site - 16 months
H. Total project duration - 18 months
- ASSESSMENT CRITERIA:
IV.1.Cost - weight:100 points
The cost should be broken down to indicate two components:
-overall cost including investigators' fees
-cost without investigators' fees
- CONTRACT TERMS:
V.1.The request for proposals shall be directed to potential CONTRACTORS conducting business as described in the contract subject matter description.
V.2.The contract may be sought by CONTRACTORS who have the required knowledge and experience as well as the technical potential and staff capable of performing the contract.
V.3.The contract may be sought by CONTRACTORS who are in an economic and financial position that ensures proper performance of the contract.
V.4.Submission of the proposal shall be equivalent to acceptance of the content of this request for proposals without reservation.
V.5.Any bidding party presenting a proposal shall have proven track record in:
- Management of similar clinical trials, i.e., phase II multicenter, randomized, double-blind, on topical dermatological application, on wound healing and wound assessment;
-Data Management (incl. database setup, data validation);
-Statistical management and analysis;
-Safety management;
-Medical writing (e.g. review of trial protocol, periodic reports, internal reports, OC of reports, preparation of reports appendices);
-Quality assurance.
V.6.The contact awarding procedure shall exclude bidders that:
- Failed to perform at least one of the previous contracts awarded by ORDERING PARTY or other ordering parties with due diligence and with regard to which an insolvency proceeding was initiated.
- Are in personal or capital relations with ORDERING PARTY Capital or personal relations shall mean mutual relations between ORDERING PARTY and the CONTRACTOR that consist in:
Participation in the company as a partner in a civil law partnership (spółka cywilna) or a partnership (spółka osobowa),
holding shares or at least 10% of stocks,
performing the role of a supervisor body or managing body member, proxy, plenipotentiary,
maintaining a legal or factual relation that may raise justified doubts as to impartiality in CONTRACTOR selection, including in particular marriage, direct affinity, secondary affinity up to the second degree, adoption, custody or guardianship.
- DEADLINE AND MANNER OF PROPOSAL SUBMISSION:
VI.1.Proposals must be submitted by 16.10.2017
VI.2.The proposal must be prepared in English language
VI.3.The proposal should be signed by persons authorized to represent the company.
VI.4.Proposals must be submitted by e-mail to:
VI.5.The date of proposal submission shall be the date of receipt of the proposal at the ORDERING PARTY’s e-mail address indicated in item VI.
VI.6.Proposals received after the deadline and those without the required annexes shall not be subject to assessment.
VI.7.The costs related to the preparation of the proposal shall be borne by the CONTRACTOR.
VI.8.Queries regarding to the subject matter of the contract should be submitted to the
email: until 29.09.2017.The replies to the queries will be provided no later than 06.10.2017.
VI.9.The proposal should indicate its validity period (at least 90 days from the date of its submission)
VI.10.The proposal must be prepared according to the template as presented in Annex 1 to the request for tender.
VI.11.The following should be attached to the proposal:
- Documents confirming the meeting of requirements regarding the contract defined in item V hereof (in the form of statements constituting Annex 2 hereto).
- Statement on lack of capital or personal relations with the ORDERING PARTY (constituting Annex 3 hereto).
- Additional information
VII.1.The contract signed with the winning bidder shall be conditional. The effectiveness of the contract is conditional to the EU grant decision within submeasure 1.1.1. of the Intelligent Development Operational Programme (call for proposals organised by The National Center of Research and Development). The final contract will be executed within the frames of a project co-financed by the European Regional Development Fund
VII.2.The ordering party reserves a right to change the terms of the contract which shall be signed as a result of this tender.
The changes may include:
a.contract deadline due to the extension of the project schedule;
b.size of the order – the increase will not exceed 50% of the value of the order included in the contract.
ANNEXES TO THE REQUEST FOR PROPOSALS:
- Proposal template
- Statements to the request for proposals confirming fulfilment of conditions indicated in item V of the above RFP
- Statement on lack of personal capital relations with the ORDERING PARTY.
ANNEX 1 TO THE REQUEST FOR PROPOSALSNo. 02/09/2017
proposal template
This proposal is submitted in connection with the request for tender from Pharmajd Sp. z o.o. (01/07/2017) for the performance of a randomized multicenter controlled Phase II clinical trial on a novel pharmaceutical topical gel for wound healing.
- Data of the bidding company:
- Name of bidding company: …………………………………………………………………………..
- Seat of the company: ………………………………………………………………
- Registration number (ID): ……………………………………………………………………………….
- Tax identification number: …………………………………………………………………………
- Contact person:
Name: ………………………………………………………………
Telephone no.: …………………………………………………………………………..
e-mail: ………………………………………………………………….
- The price proposed to perform the subject of the request for tender:
total price including investigators’ fees
price / in words
Net value
vat
gross value
TOTAL PRICE without INVESTIGATORS’ FEES
price / in words
Net value
vat
gross value
- I hereby state that I am aware of the subject of the request for tender and I have no reservations to its content.
- The proposal is valid for 90 days from the date of the submission.
- I acknowledge that if my statements are false, the offer will be rejected.
- I acknowledge that in the event of positive grant decision for the ordering party which will cover the subject of this request for tender, this request and its attachments will be visualized according to the provisions of the grant agreement.
- I acknowledge that the contract signed with the winning bidder shall be conditional. The effectiveness of the contract is conditional to the EU grant decision within submeasure 1.1.1. of the Intelligent Development Operational Programme (call for proposals organised by The National Center of Research and Development). The final contract will be executed within the frames of a project co-financed by the European Regional Development Fund.
Name:………………………..…...., date. …………
ANNEX 2 TO THE REQUEST FOR PROPOSALSNo. 02/09/2017
STATEMENTS TO THE REQUEST FOR PROPOSALS
CONFIRMING FULFILLMENT OF ITEM V CONDITIONS
I hereby state that company ………………………………………………………………………………………………………………… (name and registered address) meets the following conditions:
- It is authorized to perform the specific activity or tasks if required by the law.
- It has the required knowledge and experience as well as the technical potential and staff capable of performing the contract.
- It is in an economic and financial position to ensure performance of the contract.
- The company is not a subject to a liquidation proceeding, neither was it declared bankrupt.
- The company is not in arrears with taxes, fees or social security or health insurance premiums.
- The company was not legally convicted of an offence committed in relation with a contract awarding procedure, bribery, offence against trading or any other offence committed for financial gain; neither any partner to a general partnership, partner or board member of a limited liability partnership; general partner of a limited partnership or a limited joint stock partnership; member of a managing body of a legal person was legally convicted of an offence committed in relation with a contract awarding procedure, bribery, offence against trading or any other offence committed for financial gain.
- The company has proven track record in:
-Clinical Trial Management, includingphase II multicenter, randomized, double-blind trials, trials on topical dermatological application, trials on wound healing and wound assessment.
-Data Management (incl. database setup, data validation);
-Statistical management and analysis;
-Safety management;
-Medical writing (e.g. review of trial protocol, periodic reports, internal reports, OC of reports, preparation of reports appendices);
-Quality assurance.
…………………………………………… …………………………………………………………
Place and date Name, surname, signature, name stamp, company stamp*
*Signature of the person(s) registered to the contact obligations on behalf of the CONTRACTOR or having a relevant authorization
ANNEX 3 TO REQUEST FOR PROPOSALS No. 02/09/2017
contractor’s statement
on lack of personal or capital relations with the ordering party
I, the undersigned, hereby state that there are no capital or personal relations between …………………………………………………………………………………………………………………………………………………………………,
registered address: ……………………………………………………………………………………………………………………………… and the ORDERING PARTY:
……………………., registered address: …………………..
Personal or capital relations between …………………………………………………………………………………………………… and ORDERING PARTY shall mean mutual relations between the entities, which consists in particular in:
participation in the company as a partner in a civil law partnership (spółka cywilna) or a partnership (spółka osobowa),
holding shares at least 10% of stocks,
performing the role of a supervisory body or managing body member, proxy, plenipotentiary,
maintaining a legal factual relation that may raise justified doubts as to impartiality in CONTACTOR selection, including in particular marriage, direct affinity, secondary affinity up to the second degree, adoption, custody or guardianship.
…………………………………………… …………………………………………………………
Place and date Name, surname, signature, name stamp, company stamp*
*Signature of the person(s) registered to the contact obligations on behalf of the CONTRACTOR or having a relevant authorization