Global English
Global English Global English Poland polski Czechia Český Italy Italiano Kazakhstan Қазақ Slovakia Slovenský Spain Español Ukraine Українськa Uzbekistan Ўзбекча Vietnam Tiếng việt
Popular searches InnovationsAbout AdamedBusiness DevelopmentAdamed worldwideResearches
x

Request for proposal RFP - 028123 - ORGANISATION AND COMPREHENSIVE MANAGEMENT OF AN ONGOING PHASE I CLINICAL TRIAL (FIRST-IN-HUMAN STUDY)

In connection with the implementation of the project entitled “Phase I (Ia/Ib) clinical trial of a fusion protein with a dual anticancer mechanism”, financed from the State budget through the Medical Research Agency under project No. 2022/ABM/05/00006-00, and pursuant to Section 8 of the funding agreement, Adamed Pharma S.A. invites interested parties to submit proposals for the scope of services defined below.

Main Assumptions of the Tender Procedure

  • The Study is currently ongoing and comprises Phase Ia and Phase Ib. The Study is being conducted in Poland in an oncology patient population. The selected Bidder shall assume responsibility for the operational activities related to the Study from the incumbent CRO, while ensuring continuity of all processes relevant to participant safety, data integrity, compliance with the Study Protocol, applicable regulatory requirements, and Good Clinical Practice (GCP). Services shall be performed using the currently operational eCRF and eTMF systems. The scope of the procurement does not include data migration or replacement of the systems currently in use. 
  • The Bidder may perform part of the services with the involvement of subcontractors identified in the Proposal, subject to obtaining the Sponsor’s prior written approval. Irrespective of the involvement of subcontractors, the Bidder shall remain fully responsible to the Sponsor for the proper performance of the services, the quality of the activities performed, continuity of service delivery, and shall be liable for the acts and omissions of its subcontractors as for its own acts and omissions. 
  • The detailed allocation of responsibilities between the Sponsor, the CRO, system owners, and other parties involved in the Study shall be defined in a Responsibility Assignment Matrix (RACI) approved by the Sponsor and attached to the CRO Agreement. The scope of responsibilities assigned to the CRO and its subcontractors shall correspond to the scope of services and obligations specified in this RFP, as well as to the commitments declared by the Bidder in its submitted Proposal. 
  1. Information on the Procurement Procedure and Subject Matter of the Contract
    The subject matter of the contract is the assumption by the Contractor of responsibility for the provision of services related to the management, monitoring, and operational conduct of an ongoing Phase Ia/Ib First-in-Human (FIH) oncology clinical trial conducted at investigational sites in Poland, including the transfer of responsibilities and documentation from the incumbent CRO and ensuring continuity of Study conduct. 
    The transfer period is planned for the period from October/November through December 2026 (depending on the date of execution of the agreement with the selected Contractor). As of January 2027, the selected Contractor shall conduct the Study independently and shall be responsible for the full scope of services covered by the Agreement. 
    A detailed description of the clinical trial is provided in the Study Synopsis, which shall be made available following execution of an appropriate Non-Disclosure Agreement (NDA), in accordance with the procedure and list of appendices specified in the procurement documentation. 
    The Sponsor of the Study (the Contracting Authority) is Adamed Pharma S.A. 
    Planned Service Period: 
    • Project transition period from the incumbent CRO: October/November 2026 (depending on the date of execution of the agreement with the Contractor) through December 2026. Independent performance of the services by the selected Contractor shall commence on 1 January 2027. 
      Scope of responsibilities as of 1 January 2027: full performance of the services covered by the Agreement, in accordance with the scope specified in the RFP and the accepted Proposal. 
    • Planned service period: until 30 November 2028. The Sponsor reserves the right to extend the service period, in particular in the event of an extension of the Study duration or the occurrence of other justified project-related circumstances. 
  2. Pricing Information and Assumptions
     
    Parameter  Assumption 
    Country  Poland 
    Trial status  Active Phase Ia/Ib, FIH oncology trial 
    Active sites  4
    New sites At least 2 sites designated by the Sponsor
    Full independent operational responsibility  No later than 1 January 2027
    Planned LPLV  March 2028 
    Service period  Estimated through November 2028, extendable 
    Systems  Existing eCRF and eTMF; no planned migration 

     

  3. Delivery Model and Responsibility for Subcontractors 
    The Bidder may entrust the performance of selected services to subcontractors identified in the Proposal, subject to obtaining the Sponsor’s prior written approval. The involvement of subcontractors shall not release the Bidder from responsibility for the proper performance of the subject matter of the contract. The Bidder shall bear full responsibility towards the Sponsor for the acts and omissions of its subcontractors as for its own acts and omissions and shall ensure that subcontractors possess appropriate qualifications and resources, are subject to effective oversight in the performance of their assigned tasks, ensure continuity of service delivery, maintain effective information flow, and perform their activities in compliance with the Study Protocol, applicable laws and regulations, Good Clinical Practice (GCP), and Sponsor procedures. 
    The Proposal shall include a list of the proposed subcontractors, including details of personnel qualifications and available resources, together with the assigned scope of responsibilities, a description of the management and oversight model, communication and escalation procedures, and a business continuity plan, including a backup plan for key functions (Annex 16). 
    The scope of responsibilities assigned to subcontractors shall be fully consistent with the scope of services declared by the Bidder in its Proposal. The Sponsor expects the Bidder to retain full responsibility for the integration, coordination, and oversight of all services performed within the project, regardless of the delivery model applied. 

  4. Scope of services 

    1. Transition and Handover 
      • Ensure a seamless transfer of responsibilities from the incumbent CRO while maintaining continuity of all processes critical to participant safety, data integrity, regulatory compliance, and the execution of key operational activities. 
      • Submit, as part of the Proposal, a Transition and Handover Concept prepared using the Bidder’s own template, including at a minimum: 
        • the proposed transition strategy and methodology, 
        • a preliminary transition plan and timeline, 
        • identification of key transition-related risks together with proposed mitigation measures, 
        • assumptions regarding the transfer of knowledge, documentation, and responsibilities. 
      • The transition governance model, including roles, responsibilities, and escalation pathways (Annex 17). Following contract execution, develop a detailed Transition and Handover Plan covering all activities required for the successful assumption of the project. Conduct the transfer of knowledge and documentation in cooperation with the incumbent CRO, the Sponsor, and other relevant stakeholders, to the extent necessary to ensure a smooth and secure transfer of responsibility for the conduct of the Study. 
      • Participate in transition meetings with the incumbent CRO, the Sponsor, investigational sites, and service providers. 
      • Assume ownership of project knowledge, decision history, current activity status, risks, deviations, CAPAs, and all open issues requiring further action. 
      • Review and verify the completeness of Study documentation, including TMF/eTMF documentation, safety documentation, regulatory documentation, and contractual documentation, including the execution of assignments or agreements required to formally transfer the CRO role under Study-related contracts. 
      • Perform a comprehensive review of the monitoring status as part of the transition process, including, but not limited to, overdue monitoring visits, monitoring reports, follow-up letters, completed SDV activities, CAPAs, and other unresolved operational issues, and develop and implement an appropriate remediation plan. 
      • Assume responsibility for operational communication with investigational sites, investigators, vendors, and other parties involved in the conduct of the Study. 
      • Assume access to Study systems, including eCRF, eTMF, and other electronic tools, and verify system configuration and user access rights. 
      • Assess the overall project status and identify risks that may affect participant safety, data quality, regulatory compliance, or Study timelines, and develop appropriate mitigation plans. 
      • Ensure adequate training of the Bidder’s project team on the Study protocol, procedures, systems, and project-specific requirements. 
      • Participate in handover and/or co-monitoring visits at investigational sites where necessary to ensure the proper transfer of responsibilities. 
      • Prepare transition status reports and provide regular weekly updates to the Sponsor on the progress of transition activities. 
      • Prepare a final Transition and Handover Report confirming operational readiness for the independent conduct of the Study as of 1 January 2027. 
      • Submit the final Transition and Handover Report to the Sponsor by 20 December 2026, including at least: 
        • a list of transferred assets, processes, documents, and systems, 
        • a list of outstanding items requiring further action, 
        • confirmation of operational readiness for the independent conduct of the Study. 
      • Formal completion of the Transition and Handover process shall occur upon the Sponsor’s written approval of the final report and confirmation that the agreed readiness criteria for assuming full responsibility for Study conduct have been achieved. 
      • The outcome of the Transition and Handover process shall not result in any adjustment to the fees for services described in Sections 4.2 through 4.21. 
      • Transition Outcome: Full assumption by the New CRO (the Bidder) of responsibility for the management and operational conduct of the Study as of 1 January 2027, without adverse impact on participant safety, data integrity, GCP compliance, or continuity of Study execution. 
    2. Project Management and Study Oversight 
      • Provision of a dedicated Project Manager with appropriate experience in oncology clinical trials, responsible for the overall coordination of Study execution, including management of communications, timelines, risks, vendors, budget, decision-making processes, and escalation pathways. The Bidder shall provide a documented backup and succession model to ensure continuity of project management throughout the Study. 
      • Comprehensive project management services, including, but not limited to, management of project scope, timelines, budget, resources, risks, quality, vendors, project changes, and the implementation and follow-up of corrective and preventive actions (CAPAs). 
      • Organization and facilitation of regular operational meetings with the Sponsor, held no less frequently than once per week, including preparation of agendas, documentation of meeting outcomes, tracking of action items, and timely distribution of agreed reports and meeting summaries. 
      • Preparation of periodic project status reports covering Study progress, key study performance indicators, identified risks, open issues, corrective actions, and information related to service delivery and financial reconciliation. 
      • Ongoing oversight of recruitment performance, participant retention, and achievement of operational objectives, including the identification, analysis, and reporting of risks and deviations from project assumptions and targets. 
      • Coordination of collaboration among all functions involved in the conduct of the Study, including subcontractors, external vendors, investigational sites, and Sponsor teams. 
      • Maintenance of ongoing communication with investigational sites within the scope of assigned responsibilities, and oversight of the completeness, accuracy, timeliness, and quality of Study documentation maintained within the eTMF system and the Investigator Site File (ISF). 
      • Monitoring and ensuring compliance of Study conduct with the Study Protocol, applicable laws and regulations, Good Clinical Practice (ICH-GCP), regulatory authority requirements, and Sponsor procedures. 
    3. Site Management, Contracting and Clinical Monitoring 
      • Provide ongoing management of active investigational sites participating in the Study, as well as perform the qualification, contracting, initiation, and activation of at least two additional investigational sites designated by the Sponsor. 
      • Plan and conduct monitoring visits, including Pre-Study Visits (PSV), Site Initiation Visits (SIV), Monitoring Visits (MV), and Close-Out Visits (COV), in accordance with the approved Monitoring Plan and the characteristics of the Study, with particular focus on processes and data critical to participant safety and data integrity. 
      • Support the Sponsor in the identification, evaluation, and selection of Principal Investigators and members of the site study teams. 
      • Conduct budget negotiations and prepare, negotiate, and execute agreements with investigational sites and site personnel based on templates approved by the Sponsor, taking into account local legal and operational requirements. The CRO shall provide the necessary internal legal support for these activities. 
      • Manage amendments to executed agreements, including the preparation, negotiation, and implementation of contract amendments, assignments, and other contractual changes required throughout the course of the Study. 
      • Maintain ongoing communication with investigators and site study teams within the scope of authority delegated by the Sponsor and in accordance with the terms of the agreement with the Sponsor. 
      • Ensure the preparation, printing, version control, and distribution of all documents required for the conduct of the Study, including informed consent forms, participant information sheets, and any other documents required by the Study Protocol, regulatory authorities, or the Sponsor. 
      • Oversee the timely implementation of updates to Study documentation at investigational sites and ensure that all site documentation remains aligned with the current versions approved by the Sponsor and the relevant regulatory and ethics authorities. 
    4. Regulatory Affairs and CTIS 
      • Provide comprehensive regulatory support for the Study in compliance with Regulation (EU) No. 536/2014 (CTR), ICH-GCP requirements, and all applicable national regulations. 
      • Manage ongoing regulatory activities related to the conduct of the Study, including the preparation, submission, and coordination of the implementation of Substantial Modifications, Notification Events, Annual Safety Reports, and any other submissions required by CTIS and the relevant regulatory authorities. 
      • Prepare, review, and coordinate regulatory documentation packages, ensuring the integration of contributions from all relevant functional areas and third-party vendors. 
      • Manage the Request for Information (RFI) process, including coordination of response preparation, oversight of timelines, and verification of the completeness, accuracy, and consistency of submitted documentation. 
      • Maintain communication with the relevant regulatory authorities and ethics committees as required under the CTR and within the scope of the authorizations granted by the Sponsor. 
      • Ensure the timely implementation of approved regulatory changes at investigational sites, within Study systems, and across all applicable project documentation. 
      • Ensure consistency and alignment between regulatory documentation, site documentation, the eTMF, and all documentation implemented at investigational sites. 
    5. Pharmacovigilance 
      • Provide a suitably qualified Pharmacovigilance team, supported by an appropriate backup and succession model, to ensure the uninterrupted execution of all safety-related activities throughout the duration of the Study. 
      • Ensure that all pharmacovigilance and safety-related activities are conducted in compliance with the Study Protocol, the Safety Management Plan, applicable Sponsor procedures, ICH-GCP requirements, EudraVigilance, the Clinical Trials Regulation (CTR), and CTIS requirements. 
      • Prepare periodic safety reports and Pharmacovigilance quality metrics, including, but not limited to, reporting and case-processing timelines, follow-up activity status, and reconciliation outcomes. 
      • Maintain complete, accurate, and up-to-date Pharmacovigilance documentation, including working procedures, safety trackers, regulatory correspondence, and inspection-ready documentation. 
    6. Medical Monitoring 
      • Provide a dedicated Medical Monitor with demonstrated experience in Phase I / First-in-Human (FIH) oncology clinical trials and a thorough understanding of the requirements associated with early-phase oncology drug development studies. 
      • Submit, as part of the Proposal, a Medical Monitoring Model describing the operational framework for Medical Monitoring, including Medical Monitor availability, backup arrangements, and expected response times for medical inquiries and safety-related issues (Annex 18). 
      • Perform medical assessment and oversight of all Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and other events of special interest as defined in the Study Protocol and the Safety Management Plan. 
      • Conduct near real-time review of safety data and promptly escalate to the Sponsor any safety signals, emerging trends, or unexpected events that may impact the safety profile of the Investigational Medicinal Product (IMP). 
      • Perform regular Medical Review of clinical and laboratory data, including assessment of participant eligibility, compliance with inclusion and exclusion criteria, protocol deviations, and potential safety signals. 
      • Participate, as required, in safety reviews conducted by the Sponsor, the Data Safety Monitoring Board (DSMB), the Independent Monitoring Committee (IMC), the Steering Committee, and any other Study oversight bodies, in accordance with assigned responsibilities. 
      • Provide medical support for the preparation of the Development Safety Update Report (DSUR), safety analyses, regulatory responses, and documentation required for regulatory inspections and audits. 
    7. Clinical Data Management 
      • Take over the Data Management processes from the incumbent CRO, including assessment of the current status of the clinical database, Data Management documentation, open queries, coding activities, external data integration, reconciliation processes, data exports, and database readiness for interim and final analyses. 
      • Perform ongoing Data Management activities in accordance with the study procedures, the Data Management Plan, and Sponsor requirements. 
      • Conduct regular manual data review, data cleaning, manual edit checks, and query management, with particular focus on data critical to participant safety and data integrity. 
      • Ensure ongoing review and oversight of data related to:  
        • DLTs (Dose-Limiting Toxicities), 
        • SAEs and AESIs, 
        • dose-escalation activities, 
        • the Investigational Medicinal Product (IMP), 
        • laboratory results, 
        • PK, PD, and ADA data (if applicable). 
      • Monitor query aging, identify delays, and escalate recurring data quality issues to the Sponsor and the appropriate project functions. 
      • Perform medical coding using applicable coding dictionaries (including MedDRA, WHO Drug, or other dictionaries specified in the study documentation) and ensure the quality, completeness, and consistency of the coding process. 
      • Conduct periodic data quality analyses, including:  
        • timeliness of data entry into the eCRF, 
        • query trends and delays, 
        • completeness of critical data, 
        • recurring data corrections, 
        • unusual data changes, 
        • site-level data quality metrics, 
        • participant safety trends and signals. 
      • Conduct Data Integrity Reviews, including:  
        • audit trail analysis, 
        • monitoring of changes to critical data, 
        • identification of unusual or recurring data corrections, 
        • assessment of data quality risks, 
        • escalation of potential non-compliance and quality issues. 
      • Prepare the database for interim analyses, safety reviews, and DSMB/SC meetings, including complete documentation demonstrating database readiness. 
      • Ensure that all Data Management activities are conducted in compliance with ICH-GCP, applicable laws and regulations, Sponsor procedures, and study documentation. 
      • Minimum Data Management Frequencies and Turnaround Times 
        Area  Minimum Requirement 
        Data Cleaning  At least once per week, according to the agreed schedule 
        Manual Edit Checks  100% in accordance with the approved schedule 
        Critical Queries  Issued or escalated within 2 business days of identification 
        Standard Queries  Issued within 5 business days of identification 
        Query Aging Review At least once per week 
        Coding Review  At least once per week 
        DM Status Report  Monthly 
        Data Quality Trending Review  Monthly 
        Data Integrity Review  Monthly 
        Database Readiness Review  Prior to each planned analysis or database lock 
        DSMB/SC Data Package  In accordance with the approved schedule and data cut-off date 

         

    8. Biostatistics 
      • Continue and perform statistical activities in accordance with the approved study protocol, Statistical Analysis Plan (SAP), project timeline, and Sponsor requirements. 
      • Prepare statistical analyses, tables, listings, and summaries for safety reviews, DSMB meetings, Steering Committee reviews, and Sponsor requirements. 
      • Support the preparation of periodic safety analyses, ad hoc analyses, and presentation materials related to study progress and results. 
      • Collaborate with the Data Management team in the preparation of analysis datasets, data quality reviews, and assessment of database readiness for analyses. 
      • Prepare data outputs and statistical analyses required for interim analyses, DSMB reviews, and final analyses specified in the study protocol. 
    9. Existing eCRF and eTMF Systems 
      • The services covered under this Agreement shall be performed using the currently implemented eCRF and eTMF systems utilized for the Study. The scope of services includes the execution of clinical data management and study documentation processes, including system user support, training of site personnel, study progress monitoring, query management, data quality control, database preparation and validation, and the management of data originating from external sources. 
      • The Study is currently in its active phase, and the data collected within these systems are used for ongoing participant safety assessments, dose-escalation decision-making, interim analyses, and the fulfillment of regulatory obligations. Accordingly, the Sponsor expects the highest standards with respect to data integrity, audit trail continuity, completeness of study documentation, regulatory compliance, and the uninterrupted operation of processes supported by the eCRF and eTMF systems. 
      • A fundamental assumption of this project is the continuation of Study conduct using the currently operational systems. The Bidder shall possess the necessary resources, expertise, and experience to manage operational processes within the existing system environments without the need for data migration or platform replacement. 
      • The Bidder’s responsibilities shall include, but not be limited to: 
      • Management of user access in accordance with applicable procedures and approved role-based permissions. 
      • Organization, delivery, and documentation of training for system users. 
      • Coordination of data imports and exports. 
      • Cooperation with system vendors in the reporting, monitoring, and resolution of technical incidents. 
      • Support of validation activities where required during the course of the Study. 
      • Oversight of the quality, completeness, and timeliness of data entered into the systems. 
      • Technical maintenance of the eCRF and eTMF systems, including routine defect correction, implementation of system enhancements, system optimization, hosting, infrastructure administration, and platform validation, shall remain the responsibility of the entities contracted to provide such services, unless otherwise agreed by the Parties. The detailed allocation of roles and responsibilities between the Sponsor, the CRO, system owners, and any subcontractors shall be defined in a Sponsor-approved RACI matrix. 
    10. eTMF, ISF and Study Documentation 
      • Assume responsibility for the management of Study documentation maintained within the eTMF system and Investigator Site Files (ISF), while ensuring continuity of documentation processes and compliance with applicable regulatory requirements. 
      • Conduct a comprehensive review of all documentation generated prior to the Study transition, including assessment of document completeness, quality, classification status, and identification of any outstanding documentation deficiencies or non-compliances. 
      • Ensure the ongoing maintenance of the eTMF in accordance with EMA TMF guidelines and ICH-GCP requirements. 
      • Oversee the timely collection, review, classification, indexing, filing, and archiving of Study documentation. 
      • Ensure consistency and alignment between documentation maintained in the eTMF, site documentation (ISF), regulatory documentation, and Study source documentation. 
      • Prepare, update, and maintain all documentation required for both active and newly activated investigational sites. 
      • Perform regular documentation quality control activities, including completeness reviews of the eTMF and ISF, and provide documentation quality reports to the Sponsor at least once every three months. 
      • Monitor documentation quality metrics, including document upload timeliness, TMF completeness levels, and the status of open corrective actions. 
      • Prepare documentation for audits, regulatory inspections, and Sponsor audits within the scope of the CRO’s responsibilities. 
      • Ensure continuous inspection, audit, and regulatory readiness of the eTMF and ISF throughout the duration of the Study. 
      • Prepare Study documentation for Study close-out and archiving in accordance with Protocol requirements, applicable regulations, and Sponsor procedures. 
      • Upon completion of the services, transfer to the Sponsor a complete, verified, and organized Study documentation package, together with a report confirming documentation completeness and readiness for archiving. 
    11. IMP Labelling and Product Release 
      • The Bidder shall be responsible for organizing and managing the IMP labelling process, including release of the product for use in the Study, as a Pass-Through Cost (PTC) activity. The scope shall include, but not be limited to, the following: 
      • Approval of specifications for source materials used in the production of study labels. 
      • Preparation and provision of label text in the required format, together with maintenance of all documentation related to label text management and version control. 
      • Assignment and management of label numbering. 
      • Review and approval of label proofs prior to printing. 
      • Inspection of delivered labels and coordination of their Quality Assurance (QA) release. 
      • Performance of visual inspections of label samples. 
      • Determination of the required number of label samples. 
      • Inspection of delivered materials and review of accompanying documentation. 
      • Agreement and approval of specifications for primary and secondary packaging materials. 
      • Approval of labels for shipping containers and participation in the preparation and review of shipment documentation. 
      • Performance of IMP distribution-related activities, including verification of required authorizations and recipient licenses, coordination of shipments in compliance with Good Distribution Practice (GDP) requirements, and retention of shipment documentation for the required record-keeping period. 
      • Management of IMP destruction activities and oversight of the destruction of auxiliary medicinal products, including coordination of product returns and disposal from the manufacturing site or pharmaceutical wholesaler to investigational sites, as well as site-level management activities in accordance with defined responsibilities and applicable quality agreements. 
      • Management of the label printing process at the manufacturing site through the supplier designated by the Sponsor, including verification of compliance with Study documentation and quality agreements, accountability of investigational, auxiliary, and concomitant products, repackaging activities, product release, and archiving of investigational medicinal product documentation. 
      • Detailed IMP labelling requirements and specifications will be provided in Annex 23 following execution of a confidentiality agreement (NDA). 
    12. IMP and Auxiliary Product Logistics and Transportation 
      • Ensure and manage the transportation of the Investigational Medicinal Product (IMP) and auxiliary medicinal products from the manufacturing site and/or pharmaceutical wholesaler to investigational sites. 
      • Manage all logistics activities associated with the Study, including shipment of products to investigational sites, processing of product returns, and oversight of site-level logistics activities. 
      • Manage the ordering, supply, inventory coordination, and distribution processes for the IMP and auxiliary medicinal products throughout the Study. 
    13. Management of Quality Processes for the Investigational Medicinal Product, Auxiliary Medicinal Products and Related Materials 
      • Management of quality processes relating to the Investigational Medicinal Product (IMP), auxiliary medicinal products, and other related products and materials, in accordance with the applicable Quality Agreement(s) with suppliers of investigational products. 
    14. DSMB Administrative and Organizational Support 
      • The Bidder shall provide comprehensive administrative and organizational support for the Data Safety Monitoring Board (DSMB), including: 
      • Planning DSMB meeting schedules, organizing meetings, coordinating participants, preparing meeting agendas, materials and presentations, and providing all necessary logistical support. 
      • Coordinating the preparation of DSMB data packages, including safety data, efficacy data, recruitment metrics, treatment exposure data, dose-escalation information, Dose Limiting Toxicity (DLT) data, and any other parameters required by the Study Protocol, DSMB Charter, or Sponsor instructions. 
      • Preparing safety and efficacy reports and presentations for each DSMB meeting in accordance with the agreed data cut-off dates and approved DSMB schedule. 
      • Preparing DSMB meeting minutes, recommendations, and decisions, and submitting them for review within no more than 48 hours following the completion of each DSMB meeting. 
      • Administering payments to DSMB and committee members as Pass-Through Costs (PTC). 
    15. Site Payments and Participant Logistics 
      • Coordinate recurring financial settlements with investigational sites and site study team members, including, but not limited to, verification of services performed, preparation of payment calculations, maintenance of financial settlement records, and preparation of documentation required for payment processing by the Sponsor. 
      • Administer the reimbursement process for participant travel and accommodation expenses incurred in connection with participation in the Study, as Pass-Through Costs (PTC). Such costs shall be borne by the Sponsor; however, the CRO, acting on behalf of and for the benefit of the Sponsor, shall be responsible for the organization and administrative management of the reimbursement process, including: verification of reimbursement requests, maintenance of expense records, preparation of reimbursement reports and supporting documentation for the Sponsor, coordination of reimbursement payments, preparation and distribution of tax-related documentation, including PIT forms, where required by applicable law. 
      • Provide the Sponsor with monthly reports on participant reimbursements paid during the reporting period, including the cumulative amount reimbursed as of the reporting date. 
      • Reimbursement of travel and accommodation expenses shall be based on documentation evidencing the actual expenditure and amount incurred, including, but not limited to, tickets, invoices, receipts, or other accounting documents acceptable to the Sponsor. Acting on behalf of and for the benefit of the Sponsor, the CRO shall be responsible for maintaining and archiving records of such expenses and for ensuring the completeness of documentation required for accounting, tax, and audit purposes. 
    16. Quality Management, Audits and CAPA 
      • Maintain and regularly update project and quality risk registers within the scope of the CRO’s responsibilities, including oversight of risk mitigation activities and reporting of information required by the Sponsor to effectively oversee the conduct of the Study. 
      • Ensure that quality management activities are performed in compliance with ICH-GCP requirements, applicable laws and regulations, Sponsor procedures, the Study Protocol, and all quality plans applicable to the project. 
      • Conduct at least one Study audit during the course of the project, within a scope and timeframe agreed with the Sponsor. Audits of subcontractors, external vendors, or systems supporting the Study shall be subject to separate pricing unless explicitly included in the base Proposal. 
      • Manage protocol deviations, quality issues, audit findings, inspection findings, and Corrective and Preventive Actions (CAPA) within the scope of assigned responsibilities, including: 
        • identification and classification of quality issues, 
        • performance of Root Cause Analysis (RCA), 
        • development of CAPA plans, 
        • monitoring and follow-up of timely CAPA implementation. 
      • Maintain a CAPA register and ensure full traceability of quality-related activities, decisions, timelines, and assigned responsibilities. 
      • Maintain continuous readiness for Sponsor audits, partner audits, regulatory authority inspections, and any other assessments associated with the conduct of the Study. 
      • Support the Sponsor during audits and inspections, including preparation of documentation, participation in meetings, coordination of responses to findings, and implementation of post-audit and post-inspection actions falling within the CRO’s scope of responsibility. 
      • Ensure that all quality-related activities performed by the CRO and its subcontractors are appropriately documented, fully traceable, and readily available for Sponsor review, audits, inspections, and regulatory assessments throughout the duration of the Study. 
    17. Study Documentation 
      • Assume responsibility for the transfer, review, update, maintenance, and, where required, development of new documents and plans necessary for the effective management and conduct of the Study, including: 
        • Monitoring Plan 
        • Risk Management Plan 
        • Safety Management Plan 
        • Data Management Plan 
        • Statistical Analysis Plan (SAP) 
        • Communication Plan 
        • IMP Management Plan 
        • Laboratory Manual 
        • Pharmacy Manual 
        • As well as any other plans, procedures, work instructions, charters, trackers, reports, and documentation required to ensure the proper conduct of the Study, maintenance of regulatory compliance, effective risk management, participant safety, and data integrity. 
    18. Study Close-Out 
      • Plan, coordinate, and execute all activities related to Study close-out in accordance with the Study Protocol, Statistical Analysis Plan (SAP), applicable Sponsor procedures, ICH-GCP requirements, the Clinical Trials Regulation (CTR), and all applicable legal and regulatory requirements. 
      • Conduct the Study Close-Out process at all investigational sites, including, but not limited to, the performance of Close-Out Visits (COVs), verification of the completeness of Study documentation, closure of outstanding actions and reconciliations, final settlement of site payments, and confirmation of documentation readiness for archiving. 
      • Coordinate the closure of all operational processes associated with the Study, including regulatory activities, clinical monitoring, data management, pharmacovigilance, TMF/ISF management, and financial reconciliation activities. 
      • Ensure the resolution and closure of all outstanding queries, CAPAs, protocol deviations, safety reconciliations, reconciliation processes, and any other activities required prior to database finalization. 
      • Prepare and execute the final database lock, including documentation of database readiness and obtaining all required approvals. 
      • Finalize clinical databases, perform statistical analyses required under the Study Protocol and SAP, and prepare statistical outputs and reports required for Study close-out. 
      • Prepare the Clinical Study Report (CSR) in accordance with ICH E3 requirements, the Study Protocol, and the agreed division of responsibilities. Unless otherwise agreed by the Parties, the base scope shall include a minimum of three Sponsor review cycles. 
      • Prepare the complete Study documentation package for archiving and transfer to the Sponsor a complete, verified, and organized Trial Master File together with a report confirming its completeness and readiness for long-term archiving. 
      • Provide support to the Sponsor during any audits, regulatory inspections, or requests received following the formal completion of the Study, to the extent required under the assigned responsibilities and the applicable contractual obligations. 
    19. Procurement of Laboratory Supplies 
      • Procure laboratory materials on an ongoing basis and prepare laboratory kits using Sponsor-designated materials in accordance with Annex 19. Laboratory kits shall be customized to the applicable sample collection time points and shall include, as required: labels, primary and back-up sample collection materials, shipping documentation, transport containers and shipping cartons. The estimated maximum quantity is 750 laboratory kits, subject to adjustment during the course of the Study based on Study needs and operational requirements. 
    20. Procurement of Pharmaceutical Supply Packs and Pharmacodynamic Test Kits 
      • Procure, on an ongoing basis, pharmaceutical supply packs containing the materials and equipment required for the preparation and administration of the Investigational Medicinal Product (IMP), in accordance with the list provided by the Sponsor in Annex 20. The estimated maximum quantity is 400 pharmaceutical supply packs, subject to adjustment during the course of the Study based on Study requirements. 
      • Procure, on an ongoing basis, test kits required for pharmacodynamic assessments, in accordance with the list provided by the Sponsor in Annex 22. The estimated maximum quantity is 70 pharmacodynamic assessment kits, subject to adjustment during the course of the Study. 
    21. Transportation Services (Pass-Through Costs (PTC))
      • The Bidder shall be responsible for arranging and managing transportation services, to be reimbursed as Pass-Through Costs (PTC), including: 
      • Transportation of laboratory kits to investigational sites and from investigational sites to central laboratories, including replacement shipments and returns. 
      • Transportation of pharmaceutical supply packs to investigational sites. 
      • Transportation of pharmacodynamic test kits and samples to the designated central laboratory. 

        ​The scope of services described herein is intended solely as a summary of the principal activities for the purpose of enabling Bidders to prepare their proposals and cost estimates and does not include all detailed operational activities performed as part of the Study. The detailed scope of activities for individual functional areas, including but not limited to Clinical Operations, Clinical Monitoring, Data Management, Pharmacovigilance, and Medical Monitoring, is described in the currently applicable Study plans and related documentation. Such documents may be made available to Bidders upon request as part of the RFP clarification process, subject to the prior execution of a confidentiality agreement and/or confidentiality undertaking. 
        1. Detailed description of the project scope is provided in the Study Synopsis (Annex 2), which will be made available upon receipt from the Bidder of a signed Confidentiality Undertaking (Annex 1). 
        2. Monitoring visits and Close-Out Visits shall be planned and conducted in accordance with ICH-GCP E6(R3), Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, the applicable implementing acts to that Regulation, Directive 2001/83/EC, the principles set forth in the World Medical Association Declaration of Helsinki, applicable European Union legislation, Polish law, and the CRO’s Standard Operating Procedures. 
        3. Clinical trial documentation shall be designed and developed in accordance with ICH-GCP E6(R3), Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, the applicable implementing acts to that Regulation, Directive 2001/83/EC, the principles set forth in the World Medical Association Declaration of Helsinki, applicable European Union legislation, Polish law, and the CRO’s Standard Operating Procedures. 
        4. The Start-Up process shall be planned and conducted in accordance with ICH-GCP E6(R3), Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, the applicable implementing acts to that Regulation, Directive 2001/83/EC, the principles set forth in the World Medical Association Declaration of Helsinki, applicable European Union legislation, Polish law, and the CRO’s Standard Operating Procedures. 
          The agreement for the performance of the above-described scope of services and solutions shall be executed subject to compliance with the requirements specified in the present procurement procedure. 

          Location for delivery of the final Clinical Study Report (CSR): Adamed Pharma S.A. 

Conditions for Participation in the Procurement Procedure 

  1. The order cannot be awarded to entities affiliated personally or financially with the Contracting Authority. Personal or financial relationships are understood as mutual connections between the Contracting Authority and the Supplier or persons authorized to enter into commitments on behalf of the Contracting Authority or persons performing on behalf of the Contracting Authority activities associated with the preparation and conduct of the Supplier selection procedure, consisting in particular of:  
    1. participation in a company as a partner in a civil law partnership or commercial partnership; 
    2. holding at least 10% of shares or stock; 
    3. performing the function of a member of a supervisory body or management body, commercial proxy (prokurent), or attorney-in-fact; 
    4. remaining in a marital relationship, or in a direct line family relationship or affinity relationship, or a second-degree collateral family relationship or affinity relationship, or in a relationship resulting from adoption, guardianship, or custodianship. ​
      To meet this condition a Tenderer is required to submit a signed statement along with the offer about the lack of connections (Annex no. 3 ). 
  2. Orders cannot be awarded to:  
    1. Contractor referred to art. 7 sec. 1 indicated in lists specified in Regulation no 765/2006 and Regulation no 269/2014 or entered in list on basis of a decision on entry in the list deciding on application of measure referred to article 1 point 3 of the Act of April 13, 2022 on special solutions in field of counteracting supporting aggression against Ukraine (Polish Journal of Laws no 835). 
    2. Contractor whose beneficial owner within meaning of the Act of 1 March 2018 on counteracting money laundering and financing terrorism (Polish Journal of Laws no 593 and 655) is a person indicated in lists specified in Regulation 765/2006 and the Regulation 269/2014 or entered on  list or being such a beneficial owner from February 24, 2022, provided that it was entered on list on the basis of a decision on entry in the list determining application of measure referred to in art. 1 point 3 of the Act of April 13, 2022 on special solutions in field of counteracting supporting aggression against Ukraine (Polish Journal of Laws no 835); 
    3. Contractor whose parent undertaking or subsidiary entity within the meaning of Art. 3 sec. 1 point 37 and 39 of the Accounting Act of 29 September 1994 (Polish Journal of Laws no 217, 2105 and 2106) is an entity indicated in the lists specified in Regulation 765/2006 and Regulation 269/2014 or entered on the list or being such a parent undertaking from February 24, 2022, provided that it was entered on list on the basis of a decision on entry in list determining application of measure referred to in art. 1 point 3 of the Act of April 13, 2022 on special solutions in field of counteracting supporting aggression against Ukraine (Polish Journal of Laws no 835). 
      In order to fulfill this condition a Tenderer is obliged to send with the offer signed statement (Annex no. 4). 

  3. This Request for Proposal is addressed to entities that: 

    a) have a positive history of inspections conducted by European regulatory authorities responsible for the oversight of clinical trials or of external audits, with no critical findings identified within the last five (5) years. Such experience will be verified on the basis of a list of inspections and/or audits submitted by the Bidder, together with a brief summary of the outcomes (including the number of findings and their classification). The inspection/audit list shall be attached to the Proposal (Annex 5). The Sponsor reserves the right to request additional information regarding the submitted inspection and audit history during the evaluation of Proposals if any uncertainty arises as to its nature or scope. 

    b) have available a team member acting as Project Manager, with documented experience in at least three (3) oncology clinical trials, including at least two (2) First-in-Human (FIH) projects conducted within the last five (5) years. Such experience shall be assessed on the basis of the CVs submitted for the proposed team members. CVs shall be attached to the Proposal. The Sponsor reserves the right to contact the proposed team members to verify the declared experience and/or request additional information. Fluency in English is required and will also be assessed on the basis of the submitted CVs. In addition, documented experience in the transfer of an active clinical trial from another CRO is required for the proposed Project Manager (Annex 6). 

    c) have available one or more team members with documented experience of at least five (5) years in Regulatory Affairs/Regulatory Processes, including CTR and CTIS, and experience in at least two (2) FIH projects within the last five (5) years. Such experience shall be assessed on the basis of the submitted CVs. CVs shall be attached to the Proposal. The Sponsor reserves the right to contact the proposed team members to verify the declared experience. Fluency in English is required and will also be assessed on the basis of the submitted CVs (Annex 7). 

    d) have available at least two (2) Clinical Research Associates (CRAs), each with documented experience of at least five (5) years in the monitoring of clinical trials involving medicinal products, including participation in at least two (2) oncology clinical trial projects within the last five (5) years. Such experience shall be assessed on the basis of the submitted CVs. CVs shall be attached to the Proposal. The Sponsor reserves the right to contact the proposed team members to verify the declared experience. Fluency in English is mandatory and will also be assessed on the basis of the submitted CVs (Annex 8). 

    e) have available a team member acting as Medical Monitor with documented medical experience of at least five (5) years in oncology clinical trials, including at least one (1) year of experience in Phase I/First-in-Human (FIH) oncology studies. The relevant CV shall be attached to the Proposal. The Sponsor reserves the right to contact the proposed team member to verify the declared experience. Fluency in English is required and will also be assessed on the basis of the submitted CV (Annex 9). 

    f) have available one or more team members responsible for Data Management and Biostatistics, with documented experience of at least three (3) years in oncology clinical trials within the last five (5) years, including at least one (1) year of experience in Phase I/First-in-Human (FIH) oncology studies, covering in particular dose-escalation studies, DSMB/Steering Committee reporting, safety data review, and database lock activities. CVs shall be attached to the Proposal. The Sponsor reserves the right to contact the proposed team members to verify the declared experience. Fluency in English is required and will also be assessed on the basis of the submitted CVs (Annex 10). 

    g) have available a team member responsible for Pharmacovigilance, with documented experience of at least five (5) years in oncology clinical trials, including adverse event reporting, preparation of adverse event narratives in accordance with CIOMS standards, and related pharmacovigilance activities. Such experience shall be assessed on the basis of the submitted CVs. CVs shall be attached to the Proposal. The Sponsor reserves the right to contact the proposed team member to verify the declared experience. A good command of English is required and will also be assessed on the basis of the submitted CV (Annex 11). 

    h) have the capability to provide the required services in accordance with all requirements of this Request for Proposal on the basis of their own validated Quality Management System (QMS). In order to demonstrate compliance with this requirement, the Bidder shall provide an organizational chart of the entity together with a list of applicable Standard Operating Procedures (SOPs) (Annex 12). 

    i) have, as a CRO, experience acquired within the last five (5) years in the conduct of at least two (2) Phase I First-in-Human (FIH) clinical trials, including at least one (1) oncology clinical trial. Such experience shall be verified on the basis of redacted clinical trial agreements submitted by the Bidder (Annex 13). 

    4. Each CV submitted as part of the Proposal shall contain the following statement: 

    “I hereby consent to the processing of my personal data by Adamed Pharma S.A. for the purpose of evaluating the Proposal submitted in response to Request for Proposal No. RFP-028123, in accordance with Article 6(1)(a) of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).” 

    Additional orders may be awarded to the selected Bidder only where such orders are consistent with the principal purpose of this Agreement and provided that their total value does not exceed 50% of the value of the original contract. 

Proposal Preparation and Submission Requirements

  1. All correspondence shall include the procurement reference number in the subject line: 
    RFP-028123_Company Name 
    Proposal submission deadline: 14 October 2026, 23:59 CET. 
    Questions shall be submitted using the template Annex_14_RFP-028123_Questions_Company Name. 
    Responses to submitted questions will be provided until the conclusion of the procurement procedure. The Contracting Authority reserves the right not to respond to questions concerning the content of the procurement procedure that are received later than five (5) business days prior to the Proposal submission deadline. Submission of questions after that date may prevent the Contracting Authority from preparing and publishing responses while maintaining the principle of equal access to information for all Bidders. 
    In order to ensure equal access to information for all Bidders participating in the procurement procedure, questions and responses (with the identity of the author of the questions withheld) shall be made available to all Bidders through updates to the Request for Proposal. 
    The deadline may be changed, in which case all Suppliers will be notified by e-mail. 
  2. Each Supplier may submit only one (1) Proposal. 
  3. The Contracting Authority does not permit the submission of partial proposals covering only selected tasks. 
    The Bidder may subcontract part of the services to subcontractors identified in the Proposal, subject to obtaining the Sponsor’s prior written approval. The Bidder shall remain fully responsible for the acts and omissions of its subcontractors as for its own acts and omissions. The Proposal shall be prepared using the spreadsheet template constituting Annex 15 to this Request for Proposal: Annex_15_RFP-028123_Company Name.xlsx. Annex 15 will be made available following execution of a confidentiality agreement. Proposals submitted without a completed Annex 15 will not be considered. 
  4. The Proposal, together with all required Appendices, shall be submitted electronically to: kamil.braksator@adamed.com 
  5. In addition, the Bidder may prepare and submit a Proposal document in its own format. 
  6. The Proposal shall be prepared in either Polish or English, in a clear and legible electronic form. 
  7. The Proposal shall contain, at a minimum, the following information: Supplier name, registered address, tax identification number (NIP), RFP reference number, net price (PLN/EUR/USD), implementation/delivery timeline. 
    If prices are quoted in a currency other than PLN, they shall be converted using the average exchange rate of the National Bank of Poland (NBP) applicable on the date of publication of the procurement notice. If no NBP average exchange rate table is published on that date, the rate from the most recent average exchange rate table published prior to the date of publication of the procurement notice shall apply. 
  8. The Contracting Authority attaches a signed checklist (Appendix 21) to enable verification that all required documents have been submitted.
  9. Tenders submitted after the deadline will not be considered.  
  10. The Supplier before time-limit for receipt of tenders is entitled:  
    1. to withdraw the offer by submitting a written notification using the method specified for the submission of tenders,  
    2. to change the offer – the notification of changes must be submitted according to the same rules as the submitted offer, appropriately marked with the note "CHANGING THE OFFER". The Supplier is required to resubmit all appendices and statements with the updated date of submission of the changed offer. 

  

Evaluation Criteria and Methodology for the Assessment of Submitted Proposals

  1. The Contracting Authority is entitled to reject the tender submitted by the Supplier who does not meet the conditions for participation in the proceedings, or if the offer is incomplete or incompatible with this request.      
  2. Selection criteria:   
    1. Net price of the service (PLN/EUR), weight of the criterion – 100% of the total evaluation;
  3. The Contracting Authority shall evaluate offers based on the total number of points obtained, calculated in accordance with the above-mentioned criteria and the established scoring system:  :  
    Criteria Weight criterion [%] Method of evaluation according to the formula
    Net price of the service  100% net price of the offer with the lowest price / net price tested offer x 100 x 90 % = number of points

     

  4. As the most advantageous offer will be considered that which obtains the highest number of points.  
  5. The results of the mathematical calculations performed during the evaluation of tenders are rounded to the second decimal place. In case of at least two offers obtain equal scores, the Contracting Authority shall select, from among the offers with the highest equal final score, the offer that is more favorable in terms of environmental impact, i.e. for example the transfer of solid residues for disposal to specialized companies (e.g. unused drugs, biological samples, other materials). For this purpose, the Contracting Authority shall have the right to call the Suppliers, whose tenders have obtained the highest final points, to complete the offer by giving indicated by the Contracting Authority information about an impact of the offer on the environment. The deadline to complete the offer will be determined by the Contracting Authority, but it cannot be less than 3 working days from receipt of the request.  

 

Selection of the Contractor and Notification of Results

  1. The Contracting Authority will select the most advantageous offer on the basis of the selection criteria defined in this request for proposal. 
  2. The Ordering Party will publish the information on the results of this inquiry on the website https://www.adamed.com/ and will also send an email message to all Bidders. 

General provisions

  1. By participating in the procurement procedure, the Bidder automatically declares that its Proposal shall remain valid for a minimum period of 90 days. 
  2. The Contracting Authority reserves the right to cancel the procurement procedure without providing any reason. 
  3. In the event of cancellation of the procurement procedure, the Contractors shall not be entitled to claim reimbursement of any costs incurred in connection with their participation in the procedure. 
  4. Submission of a Proposal shall constitute acceptance, without reservation, of all conditions of the procurement procedure. 
  5. The Contracting Authority's decision not to enter into an agreement, despite having notified a Contractor of the selection of its Proposal, shall not constitute grounds for any claim for reimbursement of costs incurred in connection with participation in the procurement procedure. 
  6. During the evaluation of submitted Proposals, the Contracting Authority may request that Contractors provide clarifications regarding the content of the documents submitted as part of their Proposals. 
  7. If a Proposal does not contain all required elements, the Contracting Authority may, in justified cases, request the Contractor to supplement the missing information or documents. 
  8. The Contracting Authority reserves the right to record audio during technical meetings with Suppliers. Submission of a Proposal shall be deemed to constitute consent to the recording of such meetings. 
  9. The Contracting Authority reserves the right to negotiate Proposals with all Bidders. Negotiations may consist of multiple rounds, with the possibility of inviting a Bidder to submit an updated Proposal following each round of negotiations. 
  10. Conditions for Amendment of the Agreement 
    ​The Contracting Authority provides for the possibility of introducing material amendments to the agreement concluded as a result of this procurement procedure, in relation to the Proposal on the basis of which the Contractor was selected, where a change in the proposed and/or agreed scope of services becomes necessary as a result of, inter alia: 
    1. Changes to the scope of the Study as reflected in the Study Synopsis and/or Study Protocol; 
    2. Changes to the number of investigational sites and investigators participating in the Study; 
    3. Changes resulting from the introduction of new procedures and/or tasks. 

Any amendments or supplements to the agreement concluded with the selected Contractor shall be made in the form of written contract amendments signed by both Parties; otherwise, they shall be null and void.

Cooperation and Communication During the Proposal Preparation Process

  1. All questions shall be submitted by e-mail to: kamil.braksator@adamed.com, using the Questions Form (Annex 14). 
  2. The person authorized to communicate with Bidders from Monday to Friday between 08:00 and 16:00 is: Kamil Braksator [kamil.braksator@adamed.com]. 

 

    

 

Annex No 1  (download)

Annex No 3  (download)

Annex No 4 (download)

Annex No 14  (download)

Annex No 21  (download)