Request for Bids No. 05/WPD104/2020
June 15, 2020
Request for Bids No. 05/WPD104/2020
New approach to glioblastoma treatment addressing the critical unmet medical need
Project conducted under the contract No. POIR.01.02.00-00-0084/18-00, co-financed by the European Union under the Smart Growth Operational Program 2014-2020, Priority I: Support for Research and Development work by Enterprises, Measure 1.2: Sectorial Research and Development Programs, Sectorial Program InnoNeuroPharm.
Information No.2 for the Contractors from the 26th June 2020:
The Awarding Entity informs about the change within the template of the Important provisions of the contract. Current version is the Appendix 5. Important provisions of the contract – template version 2 from 26.06.2020.
Information No.1 for the Contractors from the 18th June 2020:
In order to expand the group of potential Contractors, the Awarding Entity informs that the deadline for submission of the bids is extended from 25.06.2020 to 30.06.2020. The bid submission time remains unchanged.
The contract object is a delivery of a database system, for conducting clinical studies.
Bid submission term:
25thJune 2020, 11.59p.m.(CET)
Bid submission method: by email to the Awarding Entity’s address:
Announcement category: Delivery
Place of the order implementation: dolnośląskie
Contact object description:
Detailed description of the contract object includes delivery of the database system constituting the eTMF system – an electronic database for creating, collecting and managing clinical trial documentation:
- Providing a database with eTMF module - an electronic system compatible with the TMF reference model (TMF Reference Model, version 3.1), meeting the EMA/FDA standards, including compliance with the requirements of ICH GCP E6 (R2) and with 21CFR Part 11 guidelines;
- System implementation and providing for the purpose of (2) two clinical trials planned to be conducted under the project, for no more than 10 clinical sites;
- System configuration and providing validation documentation;
- Providing complete information on the system update status along with maintaining the validation status (information on system revalidation);
- Providing training package for the users by a specialized team including training lasting at least 17 hours together with necessary materials/instructions;
- Technical support and ensuring the continuity of system operation throughout the duration of the contract;
- Ensuring the security of data and compliance with the requirements of the Personal Data Protection Acts (GDPR).
CPV Code: 48000000-8
CPV Code Name: Software packages and IT systems
Order delivery date:
The Term for the delivery of the contract object – the system implementation shall remain valid for up to (30) thirty days from the date of signing the contract. The delivery will be implemented in stages over a period of (36) thirty six months (system implementation and maintaining its continuous operation during the contract period).
Deadline and manner of contract execution:
- The Awarding Entity plans to sign the contact with the selected Contractor within a maximum of (30) thirty days from the date of the submission of the bids. 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 on the day of the contract is signed and end in line with its validity.
- The Awarding Entity shall pay the renumeration according to the important provisions of the contract.
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 documented experience in the delivery of the system for creating, collecting and managing clinical trial documentation (e.g. eTMF). To confirm the above, the Contractor have to demonstrate at least (2) two orders duly completed, during the last (3) three years;
- In terms of staff potential, the Awarding Entity requires Contractors to have at least (2) two persons experienced in programming and implementing similar solutions that guarantee support during the system operation;
- In terms of technical potential, the Awarding Entity requires that the Contractor have appropriate technical facility dedicated to the contract implementation, including servers for data storage, properly secured and located in the European Union or in the European Economic Area;
- The Awarding Entity requires Contractors to have implemented standard operating procedures (SOPs) covering data protection and implemented quality system covering information security confirmed by an ISO certificate (e.g. ISO 27000) or equivalent;
- The Awarding Entity requires Contractors to have implemented standard operating procedures (SOPs) covering maintenance, validation/revalidation of the electronic system as well as risk assessment;
- are in the economic and financial situation ensuring the contract implementation;
- 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 VI, 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: “Declaration of no capital or personal links;
- List of deliveries provided in accordance with the specimen indicated in paragraph 1, point 1) a, which includes:
- Contract object (i.e. type of data base/ electronic system),
- Scope and the purpose,
- Order delivery date,
- Names of the entities for which the orders have been completed (or the country of origin, if providing name of the entity is not possible), which constitutes Appendix 4 to the Request for Bids: “List of the deliveries”;
- Other documents (or certified true copies), allowing confirmation of compliance with the requirements specified by the Awarding Entity in the description of the contract object, e.g. conformity of the system with the TMF reference model (TMF Reference Model, version 3.1), meeting the EMA/FDA standards, including compliance with the requirements of ICH GCP E6 (R2) and with 21CFR Part 11 guidelines and certificate for information security, e.g. ISO 27000 or equivalent as well as standard operating procedures (SOPs) covering data protection and system maintenance, validation/revalidation and risk assessment.
- Submitted statements and documents should confirm that the conditions for the participation in the contract award procedure have been met for the date on the day of the deadline for the bid submission.
- 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.
The Awarding Entity reserves the right to verify the proper performance of the services referred in paragraph 1 point 1) by calling the selected Contractor to present at the stage of signing the contract documents confirming the proper performance of the services indicate in the bid. As a proof that the order has been duly completed, the Awarding Entity shall consider references of other documents issued by the entity, for which the order has been completed, and in the event of objective reasons that such documents cannot be obtained, a statement of the Contractor.
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 deadline of the contract execution 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 Contract,
- reducing the amount of the Contractor's remuneration due to limitation or exclusion of execution by the ordering Party part of the contract object, e.g. reducing the number of sites,
- 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 date of the contract in the event of a change in the deadline of the Project under which the contract is executed,
- changes in persons responsible for contacts and supervision over the implementation of the contract,
- changes in the company name, the place of seat of the Parties, bank account numbers and other identification data.
List of documents/declarations required from the Contractor:
Appendix No. 1. The Bid Form
Appendix No. 2. Declaration of the Contractor
Appendix No. 3. Declaration of no capital or personal links
Appendix No. 4. List of deliveries
Appendix No. 5. Documents confirming compliance with the terms for participation in the contract award procedure, including confirmation of compliance with the reference model version 3.1 (eTMF Reference Model, ver. 3.1) and EMA / FDA guidelines, including compliance with ICH GCP E6 (R2) requirements and with 21CFR Part 11 guidelines and certificate for information security, e.g. ISO 27000 or equivalent as well as standard operating procedures covering data protection and system maintenance, validation/revalidation and risk assessment.
Appendix 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:
|L.p.||Description of the Bid evaluation criteria||Value (%)|
|1||Total Gross Price (C)||60 %|
|2||Time to target resolution of the service request (CR)||40 %|
2. The score for these criteria shall be calculated as follows:
Criterion: Total Gross Price - 60 pkt
C = ----------------- x 60 % x 100
C - score granted to the evaluated bid for the total gross price criterion
C min - the lowest bid price
Cb - evaluated bid price
Criterion: time to target resolution of the service request for major incidents (High priority incidents, e.g. in particular Application Outage, Network Outage) - 40 pkt
CR = -------------x 40 % x 100
CR - score granted for time to target resolution of the service request for major incidents
CRb – evaluated bid time for target resolution of the service request for major incidents
CRmin – minimum time offered for target resolution of the service request for major incidents
NOTE: The Awarding Entity accepted the minimum time for target resolution of the service request for major incidents reported to technical support 8 hours from the time of notification and no longer than 48 hours from the time of notification. If other values are specified in the Bid Form, the bid will be rejected.
The final score will be assessed according to the formula: O = C + CR
O – the final score granted to the evaluated bid,
C – score granted for the criterion „total gross price”
CR - score granted for the criterion „Time for target resolution of the service request for major incidents”
- 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 shall be given in Polish zlotys (PLN) or 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.
- If the bid would be submitted, and the selection of this bid would lead to the establishment of the tax obligation to the Awarding Entity in accordance with the provisions on Value Added Tax Act, the Awarding Entity, in order to evaluate such bid, will add to the price presented in the Bid Form the tax on goods and services, which it would be obliged to settle in accordance with these provisions. The Contractor, by submitting the bid, informs the Awarding Entity whether the selection of the bid will lead to a tax obligation for the Awarding Entity, indicating the name (type) of the good or service whose delivery or provision will lead to its creation, and indicating their value without the amount of tax.
- 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.
- When the two or more bids receive the same score, the Awarding Entity will select the best offer by the criterion of positive environmental impact. Positive environmental impact may be demonstrated by, for example:
- the use of solutions that reduce energy consumption during service performance or during the operation of the object of the contract,
- the use of solutions that reduce or eliminate the amount of waste generated during the service performance or during the operation of the object of the contract,
- the use of solutions that reduce the consumption of consumables during the service performance or during the operation of the object of the contract,
The Contractor may indicate and describe any number of solutions having a positive impact on the environment, indicating technical parameters that allow verification of the declared impact in comparison with standard solutions.
The bid may receive (1) one point for each solution indicated regarding positive environmental impact. If no solution is indicated or solution is indicated but without technical parameters allowing verification of the declared environmental impact in comparison with standard solutions, the bid will not receive a point.
13. 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, completed in accordance with the specimen, which constitutes Appendix 1 to the Request for Bids, 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”.
- Failure to submit the declaration referred to in paragraph 3 will exclude the Contractor from the contract award procedure. Excluding the Contractor from the contract award procedure means rejection of the Bid submitted by the Contractor.
- 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