Q09070 Proposal Cheery TPZ in Cancer Phase II DM BS 20210125

Q09070: Quotation Proposal of Phase II Study Confidential
TPZ in Cancer Date: 2021/01/25
< Attachment 1: Quotation Proposal >
Full Service in Taiwan for:
An Open Label Phase II Study for the Treatment of Liver Metastatic Colorectal
Cancer and Non-Small Cell Lung Cancer with a Combination of TATE (Trans-
Arterial Tirapazamine Embolization) and Pembrolizumab
Quotation date: January 25, 2021 (Validity: 60 days)
Proposal Number: Q09070
Proposed for:
Dr. Ray Lee
Cheery Pharma Co., Ltd.
8F., No.76, Sec. 1, Minquan E. Rd., Zhongshan Dist.
Taipei 104, Taiwan
Tel: +886-2-2563-2717
Fax: +886-2-2563-2867
Proposed by:
Mr. Simon Ou
A2 Healthcare Taiwan Corporation
3F, No.1, Sec. 4, Renai Rd., Daan Dist., Taipei 106, Taiwan
E-mail: s-ou@a2healthcare.com
Tel: 886-2-8773-6997 Ext: 207
Fax: 886-2-8773-6990
CONFIDENTIAL
Proposed for: Cheery Pharma Co., Ltd. Page 1 of 17

Proposed by: A2 Healthcare Taiwan Corporation
Table of contents
1 Introduction and study information ...................................................................... 3
2 Tasks overview...................................................................................................... 5
2.1 Overview ................................................................................................... 5
3 Task Responsibility Grid....................................................................................... 6
4 Working Timeline ................................................................................................. 8
5 Service Fee Estimation ......................................................................................... 9
6.1 Service Fee Summary ............................................................................. 10

6.2 EDC Vendor Expense ............................................................................. 12
6.3 Detail of CRO service fee ....................................................................... 13

1 Introduction and study information
The document is to provide the response of a request for proposal from Cheery
Pharma Co., Ltd. to provide clinical study service for An Open Label Phase II Study
for the Treatment of Liver Metastatic Colorectal Cancer and Non-Small Cell Lung
Cancer with a Combination of TATE (Trans-Arterial Tirapazamine Embolization) and
Pembrolizumab. The requested service included data management and statistical
analysis Service in Taiwan.
An Open Label Phase II Study for the Treatment of Liver

Metastatic Colorectal Cancer and Non-Small Cell Lung
Study title
Cancer with a Combination of TATE (Trans-Arterial
Tirapazamine Embolization) and Pembrolizumab
Active Ingredient Tirapazamine
Investigational Product TPZ
Study Phase II
Primary Objective:
Determine the preliminary efficacy by ORR per RECIST 1.1
criteria as assessed by local investigator read after the
treatment of combination of TATE and pembrolizumab in
mCRC and NSCLC that are resistant to PD-(L)1 immune
checkpoint inhibitors.
Secondary Objectives
Study Objectives
• Determine the DOR associated with ORR, and the RR of
TATE untreated lesions by mRECIST and RECIST 1.1 and
their DOR after debulking treatment of TATE followed by a
maintenance therapy with a pembrolizumab in metastatic
liver cancers.
• Determine the TTP, PFS and OS of this combination.
• Determine the safety and tolerability of the combination
Study Design This is an open-label phase II study
60 eligible subjects will be recruited. Considering a 0% drop-
Number of subjects out rate, there will be at least 60 subjects evaluable for the
study to complete the enrollment.
Site number 3 site(s) (2 in Taiwan and 1 in US)
Subjects of either gender, aged above 18 years old, with a

histologically confirmed diagnosis of either (1) mCRC in
liver based on histopathology of either a prior resection of
Study Population
primary lesion or a biopsied liver metastatic lesion,
documented to be not MSI-H, or (2) metastatic NSCLC
without EGFR or ALK mutation with liver involvement.

Method of Injection of TPZ into the branch of hepatic artery that

Administration supplies the targeted tumor
Planned Enrollment 24 mo. Estimated by sponsor. Around 2 to 3
Period subjects/month/site from 3 site(s) for 60 subjects
Duration of Treatment 24 months at most, up to 35 treatment cycles
Duration of Survival For survival follow-up via phone call, not quoted in this
Follow-Up quotation proposal. To be quoted by change order if necessary
Planned Overall Study 48 months (including 24 months of enrollment, 24 months of
Period treatment, 0 months of follow up period)

2 Tasks overview
2.1 Overview
Study details
Enrollment Period 24 months
(Months)
Number of Subjects 60 eligible subjects
Total number of sites 3 site(s)
Data collection eCRF (EDC)

Adverse Events
Total # of expected 6/2
SAEs/SUSAR
AE numbers 10 events/subject for 60 subjects, 600 events in total
Project Management
Kick off meeting 1
PI meeting 1
Overall project 56 months in total ( 0 months for submission documents
management generating and preparing, 4 months for TFDA & IRB review,
including 1 month for Site initiation, 48 months for study
conducting, 3 months for CSR generating)
Site Management 50 months for 3 site(s)
IRB Annual report 2 report/year/site,
4 years of 3 site(s), 24 reports in total.
Concomitant
Medication
Concomitant 20 medicines/subject for 60 subjects, 1200 events in total
Medication
PD Report/site/year 4

3 Task Responsibility Grid
The Task Grid indicates the responsibility for Cheery Pharma Co., Ltd. and A2
Healthcare Taiwan. An “X” in either column denotes responsibility for completion of
the subtask, where as an “X” in both columns denotes shared responsibility for
completion of the subtask. For shared subtasks, an “(X)” indicates the secondary party
responsible for the task. The actual service scope and timeline could be minor
adjusted according to the output of Gap analysis summary.
Sponsor: Cheery Pharma Co., Ltd.

A2TW: A2 Healthcare Taiwan Corporation
TASKS Sponsor A2TW

A. Project initiation
1 Post award meeting X
2 Project documents' review and discussion for pre-clinical and CMC Waived
B Study Documents development
1 Design CRFs X
2 Design CRFs: review and discussion X
C Regulatory Tasks X
D Clinical Investigational Product (IP) Supplies X
E Investigator’s Meeting
1 Plan/Prepare for Investigators’ Meeting X
2 Attend Investigators’ Meeting X X
3 Develop Presentations and Present information at the Investigator X X
Meeting
F Study Initiation
G Study Conduct
H SAE Processing
1 SAE data maintenance X
2 AE-SAE reconciliation X
3 SAE narrative X
I Site Close-outs
J Data Management (EDC eCRF)
1 Data management plan X
2 Data management plan: review and discussion X
3 EDC set-up X
4 eCRF Completion Guide X
5 EDC training: preparation X
6 EDC training: Internal X
7 Data validation plan X
8 Data validation plan: review and discussion X
9 Data validation programming X
10 Data validation and data clean X

TASKS Sponsor A2TW

11 Data manual check X
12 AE coding (MedDRA) X
13 Medication coding (ATC back-end or WHODrug coding) X
14 Database / data lock preparation X
15 Generate by-subject listing (CSR Appendix 16) waived
16 Generate by-subject listing (CSR Appendix 16) - review waived
17 Achieved eCRFs from EDC X
18 Database Auditing X
19 Produce CDISC SDTM ADaM Datasets X
20 Data Transferring X
21 Archiving X
K Statistical analysis
L Clinical study report (CSR)
M CSR Regulatory submission
N TFDA inspection (half day)
O Monthly Management/Maintenance
1 TMF maintenance X
2 EDC management X
3 Overall Administration X

4 Working Timeline
The total study period completion is estimated around 56 months. The actual service
scope and timeline could be minor adjusted according to the output of Gap analysis
summary.
Milestone Duration (months)

Project review, technique documents development and
0
submission preparing
Clinical study IRB submission till approval 4
Clinical trial agreement negotiation and site initiation 1
Estimated Patient Enrollment 24
Last subject in to last subject out 24
post-study data management, statistical analysis and draft
3
clinical study reports writing
Estimated Total Timeline 56

5 Service Fee Estimation
The total CRO service fee for this partial service project is TWD $6,500,000 (after discount and including 5% VAT) for data collection via
eCRF EDC; the associated pass through cost is TWD $0 (including 5% A2 management fee and 5% VAT) for eCRF used. The cost was
estimated by using the assumption of recruiting 8 eligible and evaluable subjects from 1 study site in Taiwan. The detail quote information is
listed in tables 6.1 and 6.3.
The EDC vendor expense is TWD $1,883,400 for data collection via eCRF EDC (Medrio) used (not including 5% VAT). If the budget needs to
be managed by A2TW, 5% of A2TW management fee shall be added. The detail quote information is listed in tables 6.2.
The payment schedule will be listed in the final project contract. Travel expenses: hotel, meal, transportation, etc. will be charged at cost. The
detail quote information is listed in tables 6.1 and 6.3.

6.1 Service Fee Summary
Total Resource Associated Pass

Task Cost ($/hr*hrs) Through Cost ($)
A Project initiation $0 $0
B Study Documents development $172,800 $0
C Regulatory Tasks $0 $0
D Clinical Investigational Product (IP) Supplies $0 $0
E Investigator’s Meeting $50,400 $0
F Study Initiation $0 $0
G Study Conduct $0 $0
H SAE Processing $115,200 $0
I Site Close-outs $0 $0
J Data Management (EDC eCRF) $5,152,800 $0
K Statistical analysis $0 $0
L Clinical study report (CSR) $0 $0
M CSR Regulatory submission $0 $0
N TFDA inspection (half day) $0 $0
Total excluding monthly fee $5,491,200 $0

Administrative Management Fee (5%) $0
Grand Total (including 5% VAT) $5,765,760 $0
monthly fee total (Assumed 56 months. Not all items occurred in every month) $865,200 $0
monthly fee total (Including 5% VAT) $908,460 $0

Total Resource Associated Pass

Task Cost ($/hr*hrs) Through Cost ($)
Overall total $6,356,400 $0

Administrative Management Fee (5%) $0 $0
Overall total (Including 5% VAT) $6,674,220 $0
Discounted total (Including VAT) $6,500,000

6.2 EDC Vendor Expense
Item Cost item Estimated Cost Note

CRF Vendor Budget
1 EDC License fee (Option: Medrio) $1,883,400 Based upon annual payment schedule:
Monthly Rate 0-24M $1,470
Monthly Rate >24M $1,100
Year 1 $17,640
Year 2 $17,640
Year 3 $13,200
Year 4 $13,200
Year 5 $1,100 Total $62,780 (TWD:USD=30:1)
Grand Total (EDC Medrio, TWD) $1,883,400

6.3 Detail of CRO service fee
Amount Total Associated

Resource of Resource Pass
Resource Rate Effort Cost Through
TASKS (Title) ($/hr) (hrs) ($/hr*hrs) Cost ($) Comments
A. Project initiation $0 $0
1 Post award meeting Division 8.0 $0
heads
2 Project documents' review and discussion for Waived
pre-clinical and CMC
B Study Documents development $172,800 0.0
1 Design CRFs DMS $3,000 48.0 $144,000 48 hours for amendment, including protocol review for DM
and BS part
2 Design CRFs: review and discussion DMM $3,600 8.0 $28,800
C Regulatory Tasks By sponsor $0 $0
D Clinical Investigational Product (IP) By sponsor $0 $0
Supplies
E Investigator’s Meeting By sponsor $50,400 $0
1 Plan/Prepare for Investigators’ Meeting By sponsor 24.0 $0 PTC: $5000 for printing and filing
2 Attend Investigators’ Meeting DMM $3,600 6.0 $21,600 6 hours/attendee including traveling, half day meeting in
Taipei.
PTC: Travel cost, $2000/attendee
3 Develop Presentations and Present DMM $3,600 8.0 $28,800 8 hrs for DM, for EDC training
information at the Investigator Meeting
F Study Initiation By $0 $0
sponsor
G Study Conduct $0 $0
H SAE Processing $115,200 $0


1 SAE data maintenance PVS $3,000 12.0 $36,000 Assume 6/2 SAE/SUSAR during the study, 2 hours/SAE for
data enter and QC, via FDB PV database.
2 AE-SAE reconciliation DMS $3,000 12.0 $36,000 Assume 6/2 SAE/SUSAR during the study, 2 hours/SAE,
3 SAE narrative MW $3,600 12.0 $43,200 Assume 6/2 SAE/SUSAR during the study, 2 hours/SAE via
FDB PV database. No additional charge for CIOMS form
generating via system.
I Site Close-outs By sponsor $0 $0
J Data Management (EDC eCRF) $5,152,800 $0
1 Data management plan DMS $3,000 20.0 $60,000
2 Data management plan: review and DMM $3,600 2.0 $7,200
discussion
3 EDC set-up DMS $3,000 280.0 $840,000 By using EDC system.
4 eCRF Completion Guide DMS $3,000 40.0 $120,000
5 EDC training: preparation DMS $3,000 8.0 $24,000 For Investigators' Meeting is excluded
6 EDC training: Internal DMS $3,000 2.0 $6,000 2 hours per training per staff. Site Staffs will be trained by
CRAs.
7 EDC training: Internal PM $3,600 2.0 $7,200 2 hours per training per staff. Site Staffs will be trained by
CRAs.
8 EDC training: Internal CRA $3,000 2.0 $6,000 2 hours per training per staff. Site Staffs will be trained by
CRAs.
9 Data validation plan DMS $3,000 80.0 $240,000
10 Data validation plan: review and discussion DMM $3,600 16.0 $57,600
11 Data validation programming DMS $3,000 80.0 $240,000
12 Data validation and data clean DMS $3,000 360.0 $1,080,000 6 hours/subject for 60 subjects (≤ 100 pages / subject, not
including AE-SAE reconciliation)


13 Support PD Reporting DMS $3,000 96.0 $288,000 2 hours per PD listing, assume 48 PD Report
14 Data manual check MW $3,600 60.0 $216,000 1 hours/subject for 60 subjects,
15 AE coding (MedDRA) MW $450 600.0 $270,000 10 Adverse events /subject for 60 subjects.
Sponsor's MedDRA license fee is not included.
16 Medication coding (ATC back-end or MW $450 1,200.0 $540,000 20 medications/subject for 60 subjects.
WHODrug coding) Sponsor's WHODrug license fee is not included.
17 Database / data lock preparation DMS $3,000 16.0 $48,000 8 hours for DBL for Interim Analysis, 16 hours for DBL for
Final Analysis
18 Database / data lock preparation DMM $3,600 8.0 $28,800 4 hours for DBL for Interim Analysis, 8 hours for DBL for
Final Analysis
19 Generate by-subject listing (CSR Appendix DMS/
16) Removed
by Cheery
20 Generate by-subject listing (CSR Appendix DMM/
16) - review Removed
by Cheery
21 Achieved eCRFs from EDC DMS $3,000 8.0 $24,000 Preparation for QC on individual final eCRF (PDF file in
CD).
Archive e-CRF CD from EDC is provided by vendor
22 Database Auditing DMS $3,000 6.0 $18,000 2 hours per subject, at least 3 subject eCRF or 1/10 subjects
shall be Qced
23 Produce CDISC SDTM ADaM Datasets DMS $3,000 320.0 $960,000 Including the CDISC (SDTM, ADaM, SDRG and ADRG)
Normalization and the preparation of Define.xml. 1 interim
and 1 final review for sponsor. Final Package will be
provided to sponsor.


24 Data Transferring DMS $3,000 8.0 $24,000 Default. Including
1. Legacy data (data extracted from EDC/CDMS)
2. External data and files,
3. Database definition or Annotated eCRF for legacy data
4. SDTM / AdaM related files (if included in the contract)
25 Archiving DMS $3,000 16.0 $48,000 1. Prepare eTMF on DM/BS parts and generate inventory of
TMF.
2. Send back CD (see Data Transferring above)
3. DM/BS file internal archiving
K Statistical analysis $0 $0
L Clinical study report (CSR) $0 $0
M CSR Regulatory submission $0 $0
N TFDA inspection (half day) $0 $0
Total service fee excluding monthly $5,491,200 $0
management fee
1 TMF maintenance DM Dept. $3,000 0.5 $1,500 0.5 hours/month for 52 months of SIV to site closed
2 EDC management DMS $3,000 4.0 $12,000 2 hours/month for first site + 1 hrs/site/month for 2
additional sites including trouble shooting from user side, 50
months (SIV to database lock)
3 Overall Administration DMM $3,600 1.0 $3,600 1 hours per month for 52 months of DB ser up to DB Lock


monthly fee total $865,200
monthly fee total (Including 5% VAT) $908,460
Overall total $6,356,400 $0



Q09070 Proposal Cheery TPZ in Cancer Phase II DM BS 20210125

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Q09070 Proposal Cheery TPZ in Cancer Phase II DM BS 20210125

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Q09070: Quotation Proposal of Phase II Study Confidential

TPZ in Cancer Date: 2021/01/25

< Attachment 1: Quotation Proposal >

Full Service in Taiwan for:

Quotation date: January 25, 2021 (Validity: 60 days)

Proposal Number: Q09070

Proposed for: Cheery Pharma Co., Ltd. Page 1 of 17

1 Introduction and study information ...................................................................... 3

2.1 Overview ................................................................................................... 5

3 Task Responsibility Grid....................................................................................... 6

4 Working Timeline ................................................................................................. 8

5 Service Fee Estimation ......................................................................................... 9

6.1 Service Fee Summary ............................................................................. 10

Proposed for: Cheery Pharma Co., Ltd. Page 2 of 17

1 Introduction and study information

An Open Label Phase II Study for the Treatment of Liver

Subjects of either gender, aged above 18 years old, with a

Proposed for: Cheery Pharma Co., Ltd. Page 3 of 17

Method of Injection of TPZ into the branch of hepatic artery that

Proposed for: Cheery Pharma Co., Ltd. Page 4 of 17

Data collection eCRF (EDC)

Proposed for: Cheery Pharma Co., Ltd. Page 5 of 17

3 Task Responsibility Grid

Sponsor: Cheery Pharma Co., Ltd.

TASKS Sponsor A2TW

Proposed for: Cheery Pharma Co., Ltd. Page 6 of 17

TASKS Sponsor A2TW

Proposed for: Cheery Pharma Co., Ltd. Page 7 of 17

Milestone Duration (months)

Proposed for: Cheery Pharma Co., Ltd. Page 8 of 17

5 Service Fee Estimation

Proposed for: Cheery Pharma Co., Ltd. Page 9 of 17

6.1 Service Fee Summary

Total Resource Associated Pass

Total excluding monthly fee $5,491,200 $0

Proposed for: Cheery Pharma Co., Ltd. Page 10 of 17

Total Resource Associated Pass

Overall total $6,356,400 $0

Proposed for: Cheery Pharma Co., Ltd. Page 11 of 17

6.2 EDC Vendor Expense

Item Cost item Estimated Cost Note

Proposed for: Cheery Pharma Co., Ltd. Page 12 of 17

6.3 Detail of CRO service fee

Amount Total Associated

Proposed for: Cheery Pharma Co., Ltd. Page 13 of 17

Amount Total Associated

Proposed for: Cheery Pharma Co., Ltd. Page 14 of 17

Amount Total Associated

Proposed for: Cheery Pharma Co., Ltd. Page 15 of 17

Amount Total Associated

Proposed for: Cheery Pharma Co., Ltd. Page 16 of 17

Amount Total Associated

Overall total $6,356,400 $0

Proposed for: Cheery Pharma Co., Ltd. Page 17 of 17

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