Request for Bids No. 11/WPD104/2020
October 23, 2020
Request for Bids No. 11/WPD104/2020
New approach to glioblastoma treatment addressing the critical unmet medical need
Status: resolved, 26Nov2020
The contract object is a Clinical Research Organization (CRO) services for the purpose of clinical trials conducted by WPD Pharmaceuticals, as a part of the project No. POIR.01.02.00-00-0084/18, entitled: “New approach to glioblastoma treatment addressing the critical unmet medical need”.
Bid submission term:
24th November 2020, 11.59p.m.(CET)
Bid submission method: by email to the Awarding Entity’s address:
Announcement category: Service
Place of the order implementation: dolnośląskie
Contact object description:
The scope of the service has been presented in the form of two (2) task Packages. Detailed description of the scope of work is presented in the Appendix 1.1. to the Request for Bids
CPV Code: 73120000-9
CPV Code Name: Research and development services
Order delivery date:
The Term for the delivery of the order will start after signing the contract and end no later than December 31, 2023.
Deadline and manner of contract execution:
- The Awarding Entity plans to sign the agreement within the bid validity timeframe. This deadline may change in the event of the extension of the period of being bound by the bid.
- The deadline for contract execution shall start start upon signing the contract execution and will end in accordance with the term of its validity.
In the contract award procedure may participate Contractors who:
- have the necessary knowledge and experience and have technical potential and people capable to perform the object of the order or present a written commitment of other entities to provide technical potential and persons capable to perform the object of the order, such as
- The Awarding Entity requires Contractors to have at least six (6) years of experience in the provision of CRO services in the field of organization and conducting clinical trials (including basket trials and adaptive trial design) at the requests of Sponsors, according to GCP, including documented experience in conducting at least four (4) clinical trials in oncology (in advanced solid tumors), and
at least one (1) clinical trial in glioblastoma (GBM) in adult population, and
at least one (1) clinical trial in oncology, in pediatric patients population.
To confirm the compliance with GCP, the Contractor should document at least four (4) successfully completed GCP inspections carried out by the FDA or EMA or other regulatory authority in the last five (5) years.
- In terms of staff potential, the Awarding Entity requires Contractors to have and engage to perform the contract persons with appropriate qualification and experience, including:
at least one (1) person with a specialized education (in medical sciences, pharmacy, biotechnology, veterinary medicine, chemistry or biological sciences or related fields) on the position of Clinical Research Associate (CRA), with at least six (6) years of experience in clinical trials monitoring including monitoring at least two (2) clinical trials in oncology; and at least one (1) clinical trial in pediatric population; due to cooperation with clinical sites located in Poland, dedicated CRA must be fluent in polish; and
at least one (1) person with a medical education (specialized in oncology) with at least six (6) years of experience in medical monitoring and experienced in conducting at least one (1) phase I (first-in-human) study; and
at least one (1) person with specialized education (in medical sciences, pharmacy, biotechnology, veterinary medicine, chemistry or biological sciences, or law or other related fields) with adequate knowledge in regulatory requirements and at least two (2) years of experience in regulatory procedures, including Sci Adv, ODD and PIP; and
at least one (1) person with specialized education (in medical sciences, pharmacy, biotechnology, veterinary medicine, chemistry or biological sciences, or math or computer science or other related technical fields) with adequate knowledge and at least two (2) years of experience in data management; and
at least one (1) person with specialized education (in medical sciences, pharmacy, biotechnology, veterinary medicine, chemistry or biological sciences, or related fields) with adequate knowledgeand at least six (6) years of experience in clinical trials and team of monitors management.
- In terms of technical potential, the Awarding Entity requires that the Contractor have adequate experience in operating electronic systems dedicated for clinical trials management and conducing, as well as data collection (e.g. documented cooperation with vendors/suppliers of eCRF, eTMF, eISF systems), and have a quality system in the form of at least standard operating procedures (SOPs) covering all necessary processes of organization and conducting clinical trials in compliance with GCP. To confirm the above, the Contractor should submit the list of SOPs, including among others, such areas as: feasibility process, contracting, regulatory, study risk assessment, risk management and data protection. The Contractor should also have experience in cooperation with clinical sites conducting trials in oncology.
- are in financial and economic situation that will allow the contract object to be performed;
- are not excluded from the contract award procedure.
Contractors, in order to confirm the fulfillment of the condition for participation in the contract award procedure, shall submit the declarations and documents indicated below:
- The Bid Form completed in accordance with the specimen and signed by the Contractor, which constitutes Appendix 1 to the Request for Bids;
- Declaration of the compliance with the requirements indicated in Section V, paragraph
1 of the Request for Bids, which constitutes Appendix 2 to the Request for Bids;
- Declaration of no capital or personal links, which constitutes Appendix 3 to the Request for Bids;
- List of services provided in accordance with the specimen indicated in paragraph 1, point 1) a, b, which constitutes Appendix 4 to the Request for Bids;
- List of persons dedicated to perform the servicse, which constitutes Appendix 5 to the Request for Bids;
- Any other documents confirming fulfillment of contract award procedure participation terms (e.g. list of SOPs, list of regulatory inspections);
Assessment of compliance with the above conditions will be made in accordance with the formula “meets - does not meet”, based on information contained in the documents listed in clause 2 above. The content of the attached documents must clearly show that the abovementioned conditions are met by the Contractor.
Failure to complete at least one of the above conditions will result in exclusion of the Contractor from the contract award procedure.
The bid of the excluded Contractor shall be considered rejected. Awarding Entity shall notify the Contractor about the exclusion, stating the justification for the exclusion.
Contract amendment terms:
The Ordering Party reserves the right to amend the provisions of the contract signed with the selected Contractor in the following cases:
- changes to generally applicable legal regulations, in particular changes to tax law (e.g. the rates of goods and services tax), provided that the change has a direct impact on the performance of the contract object and may lead to the modification of only those contractual provisions it refers to;
- changes to regulations concerning the implementation of the project covered by co-financing application no. POIR.01.02.00-00-0084/18 as regards the manner of implementation or financing of tasks included in the Request for Bids, which have a direct impact on the performance of the contract with the Contractor and which may lead to the modification of those provisions of the contract that they refer to;
- the opportunity to use more modern technical solutions which are more beneficial to the Ordering Party than those which existed at the time of signing the contract, provided that they do not increase the amount of the fee due to the Contractor;
- changes concerning the execution of additional deliveries or services by the Contractor which were not included in the basic order, provided that they became essential for the delivery of the order and that the following conditions have been jointly met:
- the Contractor must not be replaced for economic or technical reasons, in particular ones which concern the interchangeability or interoperability of equipment, services or installations ordered as part of the basic order;
- a change of the Contractor would cause significant inconvenience or would drive up the cost for the Ordering Party;
- the value of each subsequent change does not exceed 50% of the value of the order specified originally in the contract.
- the change does not alter the nature of the contract and the following conditions are jointly met:
- the need to amend the contract is due to circumstances which the Ordering Party, acting in good faith, could not have foreseen and
- the value of the change does not exceed 50% of the value of the order specified originally in the contract;
- The Contractor who was awarded the contract by the Ordering Party is to be replaced by a new contractor:
- on the basis of contractual obligations, provided that they do not alter the nature of the contract,
- as a result of a merger, division, transformation, bankruptcy, restructuring or acquisition of the existing contractor or its enterprise, provided that the new contractor meets the conditions for participation in the procedure, there are no grounds for its exclusion from the procedure and that the change does not entail any other significant amendments to the contract,
- as a result of the Ordering Party taking over the Contractor’s obligations towards its subcontractors;
- the change does not alter the nature of the contract and the total value of the change is less than the amount specified under Art. 11 paragraph 8 Public Procurement Law, on which depends the obligation to submit notices to the European Union Publication office and at the same time it is less than 10% of the value of the order specified in the original contract;
- there are discrepancies or ambiguities in the contract which cannot be eliminated in any different manner and the change will make it possible to eliminate such discrepancies and make the contract more precise in order to ensure its unambiguous interpretation by the parties;
- the occurrence of a force majeure event;
- changing the dates of the contract in the event of external causes beyond the control of the Ordering Party or the Contractor resulting in the inability to meet the original deadlines arising from the Contractor,
- reducing the amount of the Contractor's remuneration due to limitation or exclusion by the ordering Party implementation of part of the contract object,
- extension of the deadline for implementation of the contract object in the event of extension of the registration procedure or other procedures in the appropriate offices and institutions,
- changing the term of the contract in the event of a change in the date of the Project implementation under which the contract is implemented,
- changes in persons responsible for contacts and supervision over the implementation of the contract,
- changes of the data, such as: the company name, the place of seat of the Parties, bank account numbers and other identification data,
- extending he scope of work specified in the description of the contract object, which may prove necessary to perform in accordance with the applicable legal quidelines and regulations.
List of documents/declarations required from the Contractor:
Appendix No. 1. The Bid Form
Appendix No. 2. Declaration of the compliance with the requirement
Appendix No. 3. Declaration of no capital or personal links
Appendix No. 4. List of services
Appendix No. 5. List of personsAppendix No. 6. Power of attorney to represent the Contractor (if applicable)
Bid evaluation criteria and method:
- In selection the best offer the Awarding Entity shall evaluate the criteria: the total gross prices of the Contract Object descripted in Section III(3) on the basis of the information supplied by the Contractor in the Bid Form.
- The score for this criterion shall be calculated as follows:
Lowest bid price
Score granted to the evaluated offer =---------------------- x 100
Evaluated bid price
- The score will be expressed with the accuracy of up to two decimal places.
- As a result of the evaluation, according to the criterion indicated in the clause 1 above, the bid may receive the score of maximum 100 points.
- The most economic and best quality bid shall be the one which has not been excluded from the procedure and which receives the highest score during the evaluation.
- The price may be given in any currency other than PLN.
- The price must be expressed numerically with the accuracy of up to two decimal places and in words.
- The price must include all the costs of the contract including all fees and taxes (including goods and services).
- Any other costs which have been incurred by the Contractor while completing the order and have not been included in the bid price will not be additionally covered by the Awarding Entity.
- Bids submitted by the foreign Contractors participating in the contract award procedure, who under other regulations are not obligated to pay VAT in Poland, contain prices without VAT (0% VAT). Tax liability in the situation of acquiring goods or services from foreign entities rests with the Awarding Entity, in accordance with the provisions of the Value Added Tax Act. For the purpose of comparing the bids Awarding Entity will add to the bid price submitted by the foreign Contractors, the amount of VAT and custom duty (if applicable, for Contractors from outside the European Union), which are charged to the Awarding Entity for the performance of the contract.
- For the purpose of comparing the bids the bid price in a foreign currency will be converted into PLN using the average exchange rate given by the National Bank of Poland (NBP) valid for the day of the request for bids publication in the Competitiveness Base. Average exchange rate is available at the NBP official web site: http://www.nbp.pl.
- The prices stated in the bid shall remain valid throughout the entire period of its validity and shall be binding for the signed contract.
- The Awarding Entity shall award the contract to the Contractor whose bid received the highest score during the evaluation process.
Grounds for exclusion from the contract award procedure:
- Excluded from the contract award procedure shall be Contractors who:
- do not meet the conditions listed in Section VI;
- performed activities directly related to the preparation of the contract award procedure or used to prepare the bid with persons participating in these activities, unless the participation of these contractors does not hinder the fair competition;
- submitted false information affecting the outcome of the contract award procedure.
- Contractors who have capital or personal links to the Awarding Entity shall also be excluded from participation in the contract award procedure; capital or personal links shall be understood as mutual ties between the Contractor and the Awarding Entity or persons authorized to incur obligations on behalf of the Awarding Entity, or persons performing any activities related to the contractor selection procedure on behalf of the Awarding Entity; such links shall in particular include:
- participation in the company in the capacity of a partner in a civil law company or partnership;
- ownership of at least 10% of shares or stock, provided that a lower threshold is not mandated under legal regulations or rules concerning the principles of implementation of the project covered by the Request for Bids,
- holding the function of a member of a supervisory or management body, a commercial representative or an attorney;
- being married to or having lineal consanguinity or direct affinity, collateral consanguinity or affinity to the second degree to, or being adopted by, or being under the guard or custody of such persons,
or any other relationships which may result in the conflict of interests while awarding the contract and in the violation of the competition principle. Should any capital or personal links be revealed between the Contractor and the Awarding Entity, the contract shall not be awarded to the Contractor.
- In order to demonstrate the absence of premises referred to in the paragraph 2, being the basis for excluding the Contractor from participation in the contract award procedure, the Contractor is obligated to submit together with the Bid Form, declaration of no capital or personal links, according to the specimen, which constitutes Appendix 3 to the Request for Bids: “Declaration of no capital or personal links”.
- The Awarding Entity may exclude the Contractor from the contract award procedure at any stage.
Awarding Entity Name:
Żwirki i Wigury 101
02-089 Warszawa, Poland
Telephone Number: +48 515262381
Tax Number: 5252721500