„Evaluation of the Safety, Efficacy, and Dose Optimization of Intra-Articular Allocetra Administration in Adult Participants with Symptomatic Primary Age-Related Knee Osteoarthritis”
Notice description
ANNOUNCEMENT DATED MARCH 20, 2026
We would like to inform you that the content of the request for proposals has been updated.
In connection with the implementation of project(s) entitled "Evaluation of the Safety, Efficacy, and Dose Optimization of Intra-Articular Allocetra Administration in Adult Participants with Symptomatic Primary Age-Related Knee Osteoarthritis” applying for funding in the call no. FENG.01.01-IP.02-001/26 under the European Funds for Smart Economy program and in connection with the obligation to make purchases based on the most economically advantageous offer, observing the principles of fair competition, efficiency, openness and transparency, ENLIVEX POLAND submits an inquiry regarding the implementation of Research services.
SCOPE OF THE WORK:
PhaseV will support Enlivex Poland in the analysis of an additional cohort of patients that should be added to the Customer’s Phase 2b OA trial (ENX-CL-05-002)
Methodology & Deliverables
The scope of work may include, inter alia, the following components; provided, however, that such components are non-exhaustive and shall be further discussed and agreed between the Parties in accordance with Section 1 (condition precedent) set forth above.
Pre- Study execution services:
1. Study design:
● Develop randomization and stratification strategy with statistical justification
● Define study population and sample size requirements with appropriate statistical assumptions
● Conduct comprehensive power analysis and sample size calculations, including sensitivity analyses, aligned with study objectives, design, and endpoint
2. Trial Synopsis
● Prepare a synopsis for the selected trial design, summarizing key elements, procedures, and an initial feasibility assessment to support future regulatory submission
● Draft statistical sections for the synopsis or protocol, including statistical © Copyright 2026 PhaseV Trials Inc. Confi dential, Under CDA only
justification documents for novel design elements or analytical approaches
3. Statistical Analysis Plan (SAP) Development
● Develop a detailed SAP covering all primary and secondary analyses
● Define analysis populations (intent-to-treat, per-protocol, safety) with clear statistical rationale
● Specify statistical methods and models appropriate for the study design and endpoints
● Incorporate advanced statistical modeling, including missing data handling and subgroup analysis plans.
4. Advisory Support
● Provide ongoing support for trial design discussions with FDA, EMA, and other regulators
● Address regulator questions and feedback, supplying materials and responses to support the design
5. Protocol review
BIOSTATISTICS
● CRF Review
● Randomization schedule (list)
● TLF Shells Unique
● TLF Shells Repeat
● Biostatistics Data Review Meetings
● CSR Review
SDTM
● SDTM Annotated CRF
● SDTM Dataset Programming
● SDTM Programming (External Vendors)
● SDTM cSDRG
● SDTM Define.xml
● SDTM Oversight and Review © Copyright 2026 PhaseV Trials Inc. Confi dential, Under CDA only
ADaM
● ADaM Specification
● ADaM Dataset Programming
● ADRG
● ADaM Define.xml
● ADaM Oversight and Review
OUTPUT DEVELOPMENT
● Tables Unique
● Tables Repeat
● Listings
● TLF Oversight and Review
SUBMISSION PACKAGE
● SDTM Submission Package
● ADaM Submission Package
DSMB
● DSMB: Derived Datasets
● DSMB: Tables Unique
● DSMB: Listings
● DSMB Datasets Rerun (Unblinded)
● DSMB Output Rerun (Unblinded)
● Prepare DSMB Report (Unblinded)
● DSMB Meeting Participation
● DSMB Oversight and Review
● DSMB Subsequent Derived Datasets Rerun (Blinded)
● DSMB Subsequent Output Rerun (Blinded)
● DSMB Subsequent Datasets Rerun (Unblinded) ● DSMB Subsequent Output Rerun (Unblinded)
● Prepare DSMB Subsequent Report (Unblinded)
● DSMB Subsequent Meeting Participation
● DSMB Subsequent Oversight and Review
DRY RUN
● SDTM Rerun
● ADaM Rerun
● TLF Rerun
● Dry Run Delivery Oversight and Review © Copyright 2026 PhaseV Trials Inc. Confi dential, Under CDA only
5
Interim / TLR analysis
● Interim SDTM Datasets
● Interim ADaM Datasets
● Interim Tables Unique
● Interim Tables Repeat
● Interim Listings
● Interim Datasets Rerun (Unblinded)
● Interim Outputs Rerun (Unblinded)
● Interim Delivery Oversight and Review
● Interim Datasets Rerun (Unblinded)
● Interim Outputs Rerun (Unblinded)
FINAL ANALYSIS
● Final: SDTM Rerun
● Final: ADaM Rerun
● Final: TLF Rerun
● Final: Delivery Oversight and Review
Project Management
● Project Management Set-Up
● Project Management and Meetings
Services Total Amount: 360,000 $
This request for proposals is conditional, meaning that the supplier selected in this procedure will be entered into a conditional agreement by the Contracting Authority. The conditional agreement will only come into effect if the Contracting Authority concludes a funding agreement for the project.
For the avoidance of doubt, in the event that the funding agreement for the Project is not concluded, neither party shall have any liability to the other, except for obligations expressly agreed as pre-contractual.
- The Ordering Party does not allow the possibility of submitting partial offers (1 part of the subject of the order).
- The Ordering Party does not allow the possibility of submitting variant offers.
ORDER COMPLETION DATE: The execution of orders under the contract must take place within max (lead time): to June 2028 The timelines set out above are indicative and may be reasonably adjusted in the event of delays arising from factors beyond the Contractor’s control, including but not limited to site activation timelines, patient recruitment rates, third-party dependencies, or force majeure events.
Miejsce realizacji
Cała polska
We would like to inform you that the content of the request for proposals has been updated.
In connection with the implementation of project(s) entitled "Evaluation of the Safety, Efficacy, and Dose Optimization of Intra-Articular Allocetra Administration in Adult Participants with Symptomatic Primary Age-Related Knee Osteoarthritis” applying for funding in the call no. FENG.01.01-IP.02-001/26 under the European Funds for Smart Economy program and in connection with the obligation to make purchases based on the most economically advantageous offer, observing the principles of fair competition, efficiency, openness and transparency, ENLIVEX POLAND submits an inquiry regarding the implementation of Research services.
SCOPE OF THE WORK:
PhaseV will support Enlivex Poland in the analysis of an additional cohort of patients that should be added to the Customer’s Phase 2b OA trial (ENX-CL-05-002)
Methodology & Deliverables
The scope of work may include, inter alia, the following components; provided, however, that such components are non-exhaustive and shall be further discussed and agreed between the Parties in accordance with Section 1 (condition precedent) set forth above.
Pre- Study execution services:
1. Study design:
● Develop randomization and stratification strategy with statistical justification
● Define study population and sample size requirements with appropriate statistical assumptions
● Conduct comprehensive power analysis and sample size calculations, including sensitivity analyses, aligned with study objectives, design, and endpoint
2. Trial Synopsis
● Prepare a synopsis for the selected trial design, summarizing key elements, procedures, and an initial feasibility assessment to support future regulatory submission
● Draft statistical sections for the synopsis or protocol, including statistical © Copyright 2026 PhaseV Trials Inc. Confi dential, Under CDA only
justification documents for novel design elements or analytical approaches
3. Statistical Analysis Plan (SAP) Development
● Develop a detailed SAP covering all primary and secondary analyses
● Define analysis populations (intent-to-treat, per-protocol, safety) with clear statistical rationale
● Specify statistical methods and models appropriate for the study design and endpoints
● Incorporate advanced statistical modeling, including missing data handling and subgroup analysis plans.
4. Advisory Support
● Provide ongoing support for trial design discussions with FDA, EMA, and other regulators
● Address regulator questions and feedback, supplying materials and responses to support the design
5. Protocol review
BIOSTATISTICS
● CRF Review
● Randomization schedule (list)
● TLF Shells Unique
● TLF Shells Repeat
● Biostatistics Data Review Meetings
● CSR Review
SDTM
● SDTM Annotated CRF
● SDTM Dataset Programming
● SDTM Programming (External Vendors)
● SDTM cSDRG
● SDTM Define.xml
● SDTM Oversight and Review © Copyright 2026 PhaseV Trials Inc. Confi dential, Under CDA only
ADaM
● ADaM Specification
● ADaM Dataset Programming
● ADRG
● ADaM Define.xml
● ADaM Oversight and Review
OUTPUT DEVELOPMENT
● Tables Unique
● Tables Repeat
● Listings
● TLF Oversight and Review
SUBMISSION PACKAGE
● SDTM Submission Package
● ADaM Submission Package
DSMB
● DSMB: Derived Datasets
● DSMB: Tables Unique
● DSMB: Listings
● DSMB Datasets Rerun (Unblinded)
● DSMB Output Rerun (Unblinded)
● Prepare DSMB Report (Unblinded)
● DSMB Meeting Participation
● DSMB Oversight and Review
● DSMB Subsequent Derived Datasets Rerun (Blinded)
● DSMB Subsequent Output Rerun (Blinded)
● DSMB Subsequent Datasets Rerun (Unblinded) ● DSMB Subsequent Output Rerun (Unblinded)
● Prepare DSMB Subsequent Report (Unblinded)
● DSMB Subsequent Meeting Participation
● DSMB Subsequent Oversight and Review
DRY RUN
● SDTM Rerun
● ADaM Rerun
● TLF Rerun
● Dry Run Delivery Oversight and Review © Copyright 2026 PhaseV Trials Inc. Confi dential, Under CDA only
5
Interim / TLR analysis
● Interim SDTM Datasets
● Interim ADaM Datasets
● Interim Tables Unique
● Interim Tables Repeat
● Interim Listings
● Interim Datasets Rerun (Unblinded)
● Interim Outputs Rerun (Unblinded)
● Interim Delivery Oversight and Review
● Interim Datasets Rerun (Unblinded)
● Interim Outputs Rerun (Unblinded)
FINAL ANALYSIS
● Final: SDTM Rerun
● Final: ADaM Rerun
● Final: TLF Rerun
● Final: Delivery Oversight and Review
Project Management
● Project Management Set-Up
● Project Management and Meetings
Services Total Amount: 360,000 $
This request for proposals is conditional, meaning that the supplier selected in this procedure will be entered into a conditional agreement by the Contracting Authority. The conditional agreement will only come into effect if the Contracting Authority concludes a funding agreement for the project.
For the avoidance of doubt, in the event that the funding agreement for the Project is not concluded, neither party shall have any liability to the other, except for obligations expressly agreed as pre-contractual.
- The Ordering Party does not allow the possibility of submitting partial offers (1 part of the subject of the order).
- The Ordering Party does not allow the possibility of submitting variant offers.
ORDER COMPLETION DATE: The execution of orders under the contract must take place within max (lead time): to June 2028 The timelines set out above are indicative and may be reasonably adjusted in the event of delays arising from factors beyond the Contractor’s control, including but not limited to site activation timelines, patient recruitment rates, third-party dependencies, or force majeure events.
Miejsce realizacji
Cała polska
Time limit for receipt of tenders
2026-03-26 22:59:59.0
Location
Kraj: Polska
Category assortment
Measurements, tests and technical acceptance
Buyer details
ENLIVEX POLAND SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
Królewska 2/32
00-065 Warszawa
Województwo: mazowieckie
Kraj: Polska
NIP: 5253059061
Królewska 2/32
00-065 Warszawa
Województwo: mazowieckie
Kraj: Polska
NIP: 5253059061
