CLINICAL TRIAL QUOTATION (PHASE 3 ONCOLOGY GLOBAL)
Client: 12 months Study title: 24 months Phase: 6 months Th. area: 12 months Subjects: 6 months Sites: 60 months Spain France 10 Germany 3 Poland 800 United Kingdom 240 United States No. Task Title Description Role Stage Units Unit Type Price/Unit Total 1 ETHICS/REGULATORY $214.200,00 1.1 Site document collection (submissions) Collection and preparation of site documents required for initial EC/RA submissions RSP SU 80 sites $720,00 $57.600,00 1.2 Insurance (initial) Issuance of initial insurance policy RSP SU 5 policies $240,00 $1.200,00 1.3 Insurance (updates) Insurance policy updates and/or renewals RSP SU 25 updates $120,00 $3.000,00 1.4 EC submission Ethics committee (EC) initial application submission (preparation, submission, response to clarifications including requested changes) RSP SU 6 submission $6.000,00 $36.000,00 1.5 RA submission Regulatory authority (RA) initial application submission (preparation, submission, response to clarifications including requested changes) RSP SU 5 submissions $6.000,00 $30.000,00 1.6 EC/RA amendments Study amendments (including document changes and EC/RA approvals) RSP RE, TR, FU 36 amendments $1.440,00 $51.840,00 1.7 EC/RA reporting EC and RA reporting (study initiation, first patient, APR, DSUR, close-out) RSP SU, RE, TR, FU, CO 120 communications $120,00 $14.400,00 1.8 Site reporting Site reporting (study initiation, first patient, APR, DSUR, close-out) RSP SU, RE, TR, FU, CO 120 communications $120,00 $14.400,00 15 15 10 10 10
SERVICES Start-up (SU): IMV total (FU): IMV per site (RE, TR): IMV per site (FU): IMV total (RE, TR): Recruitment (RE): Treatment (TR): Follow-up (FU): Close-out (CO): Study total: Biotech Company Phase 3 Global Oncology Clinical Trial with Drugs 3 Oncology 300 80 20
CRO
1.9 APR (writing) Writing and review of annual progress report (APR) RSP RE, TR, FU, CO 4 reports $1.440,00 $5.760,00 2 SITE CONTRACTING AND PAYMENTS $196.800,00 2.1 Site contracting Negotiation and execution of site contracts (including budgets) SCS SU 80 contracts $1.440,00 $115.200,00 2.2 Site payments (start-up) Payments to sites related to start-up fees (contract, pharmacy, etc.) ADM SU 80 sites $60,00 $4.800,00 2.3 Site payments (visits) Payments to sites related to patient fees (visit costs) ADM RE, TR, FU, CO 80 sites $960,00 $76.800,00 3 SITE SELECTION $193.160,00 3.1 FQ development Writing and review of feasibility questionnaire (FQ) SCRA SU 1 FQ $660,00 $660,00 3.2 FQ collection Preparation, distribution, collection, and review of feasibility questionnaires (FQs) SCRA SU 100 sites $440,00 $44.000,00 3.3 Onsite SQV Onsite site qualification visit (SQV) (preparation, travel, visit, report, follow-up) SCRA SU 90 visits $1.650,00 $148.500,00 4 SITE INITIATION AND ACTIVATION $167.200,00 4.1 Onsite SIV Onsite site initiation visit (SIV) (preparation, travel, visit, report, follow-up) SCRA SU 80 visits $1.760,00 $140.800,00 4.3 Site activation Site activation (document verification and system access activation) SCRA SU 80 sites $330,00 $26.400,00 5 SITE MANAGEMENT $3.801.600,00 5.1 Site management (RE, TR) Communication with sites to provide support and solve doubts. Respond to all site inquiries. Recruitment helpdesk. Ensure sites always have updated documentation. SCRA RE, TR 2400 site-month $1.320,00 $3.168.000,00 5.2 Site management (FU) Communication with sites to provide support and solve doubts. Respond to all site inquiries. Recruitment helpdesk. Ensure sites always have updated documentation. SCRA FU 960 site-month $660,00 $633.600,00
6 MONITORING $2.663.760,00 6.1 CRA trainings (initial) Initial review of study documents and system trainings SCRA SU 1 study $21.120,00 $21.120,00 6.2 CRA trainings (subsequent) Subsequent training sessions during the study SCRA RE, TR, FU 1 study $42.240,00 $42.240,00 6.3 Onsite IMV (RE, TR) Onsite interim monitoring visit (IMV) during recruitment and treatment (preparation, travel, visit, report, follow-up) SCRA RE, TR 800 visits $2.310,00 $1.848.000,00 6.4 Onsite IMV (FU) Onsite interim monitoring visit (IMV) during follow-up (preparation, travel, visit, report, follow-up) SCRA FU 240 visits $2.310,00 $554.400,00 6.5 Data reviews Remote review of EDC clinical data and query management SCRA RE, TR, FU 300 subjects $660,00 $198.000,00 7 CLOSE-OUT $202.400,00 7.1 Onsite COV Onsite close-out visit (COV) (preparation, travel, visit, report, follow-up) SCRA CO 80 visits $2.530,00 $202.400,00 8 SAFETY $138.160,00 8.1 Safety database setup Initial configuration and setup of safety database SCRA SU 1 study $5.280,00 $5.280,00 8.2 SAE management Receipt, review, listing, and follow-up of SAEs including reporting to Sponsor and/or Medical Monitor SCRA RE, TR, FU 250 SAEs $440,00 $110.000,00 8.3 SUSAR management Receipt, review, listing, and follow-up of SUSARs including reporting to Sponsor and/or Medical Monitor and regulatory authority SCRA RE, TR, FU 10 SUSARs $880,00 $8.800,00 8.4 DSUR (writing) Writing and review of annual safety report (DSUR) SCRA RE, TR, FU 4 reports $3.520,00 $14.080,00 9 DRUG LOGISTICS $271.780,00 9.1 Depot contracting Drug depot selection and contracting CPM SU 1 contract $4.480,00 $4.480,00 9.2 Drug shipments to depot Communication with drug manufacturer for the shipment of drug to depot SCRA RE, TR 10 shipments $330,00 $3.300,00 9.3 Drug shipments to sites Communication with sites to verify drug stock availability. Coordination of drug shipments to sites in communication with depot including supervision of drug destruction and returns. SCRA RE, TR 2400 site-month $110,00 $264.000,00
10 CLINICAL SUPPLIES LOGISTICS $105.700,00 10.1 Purchasing of clinical supplies Purchasing of kit components (bags, etc.) CTA SU, RE, TR 10 orders $70,00 $700,00 10.2 Kit preparation Preparation of clinical supplies (lab kits) including shipments CTA SU, RE, TR 300 kits $70,00 $21.000,00 10.3 Kit tracking Ongoing tracking of clinical supplies (lab kits) at sites CTA RE, TR 2400 site-month $35,00 $84.000,00 11 FILES/DOCUMENT MANAGEMENT $560.000,00 11.1 TMF setup Initial configuration and setup of TMF CTA SU 1 study $5.600,00 $5.600,00 11.2 TMF maintenance TMF maintenance during entire study conduct CTA RE, TR, FU 900 site-month $280,00 $252.000,00 11.3 TMF reconciliation Final reconciliation of TMF to ensure completion CTA CO 80 sites $1.120,00 $89.600,00 11.4 ISF preparation Investigator Site File (ISF) preparation and shipment to sites CTA SU 80 sites $140,00 $11.200,00 11.5 Document management Management of other documents (as needed) CTA RE, TR, FU, CO 48 months $4.200,00 $201.600,00 12 MEDICAL WRITING $51.920,00 12.1 Protocol writing Writing and review of full study protocol MWR SU 1 protocol $8.800,00 $8.800,00 12.2 Protocol synopsis translation Translation and review of protocol synopsis MWR SU 1 synopsis set $1.760,00 $1.760,00 12.3 PIS/ICF writing Writing, translation, adaptation, and review of PIS/ICF MWR SU 1 PIS/ICF set $5.280,00 $5.280,00 12.4 Abstract writing Writing and review of abstract MWR CO 1 abstract $1.760,00 $1.760,00 12.5 Poster writing Writing and review of poster MWR CO 1 poster $3.520,00 $3.520,00 12.6 Manuscript writing Writing and review of manuscript MWR CO 1 manuscript $13.200,00 $13.200,00 12.7 CSR writing Writing and review of clinical study report (CSR) MWR CO 1 report $17.600,00 $17.600,00 13 PROJECT MANAGEMENT $3.771.520,00 13.1 CPM trainings (initial) Initial review of study documents and system trainings CPM SU 1 study $8.960,00 $8.960,00 13.2 CPM trainings (subsequent) Subsequent training sessions during the study CPM SU 1 study $17.920,00 $17.920,00 13.3 Study plans and manuals Development and review of study plans and manuals (Communication Plan, Monitoring Plan, TMF Plan, Safety Management Plan, Laboratory Manual) CPM SU 5 plans/manuals $3.360,00 $16.800,00
13.4 CPM internal meetings (SU, RE, TR) Internal meetings (4 TC per month) x 4 CPM CPM SU, RE, TR 672 TCs $140,00 $94.080,00 13.5 CPM internal meetings (FU, CO) Internal meetings (1 TC per month) x 4 CPM CPM FU, CO 72 TCs $140,00 $10.080,00 13.6 CPM Sponsor meetings (SU, RE, TR) Regular meetings with the Sponsor (4 TC per month) x 4 CPM CPM SU, RE, TR 672 TCs $140,00 $94.080,00 13.7 CPM Sponsor meetings (FU, CO) Regular meetings with the Sponsor (1 TC per month) x 4 CPM CPM FU, CO 72 TCs $140,00 $10.080,00 13.8 CRA internal meetings (SU, RE, TR) Internal meetings (4 TC per month) x 12 CRAs SCRA SU, RE, TR 2016 TCs $110,00 $221.760,00 13.9 CRA internal meetings (FU, CO) Internal meetings (1 TC per month) * 12 CRAs SCRA FU, CO 216 TCs $110,00 $23.760,00 13.10 CRA Sponsor meetings (SU, RE, TR) Regular meetings with the Sponsor (4 TC per month) x 12 CRAs SCRA SU, RE, TR 2016 TCs $110,00 $221.760,00 13.11 CRA Sponsor meetings (FU, CO) Regular meetings with the Sponsor (1 TC per month) x 12 CRAs SCRA FU, CO 216 TCs $110,00 $23.760,00 13.12 Study management (SU, RE, TR) Study financial management and supervision of study costs. Vendor management. Respond to all Sponsor requests. Newsletters during recruitment. CPM SU, RE, TR 42 months $56.000,00 $2.352.000,00 13.13 Study management (FU, CO) Study financial management and supervision of study costs. Vendor management. Respond to all Sponsor requests. CPM FU, CO 18 months $28.000,00 $504.000,00 13.14 Review of SIV reports Supervision, review and follow-up of site initiation visit (SIV) reports CPM SU 80 reports $140,00 $11.200,00 13.15 Review of IMV reports Supervision, review and follow-up of interim monitoring visit (IMV) reports CPM RE, TR, FU 1040 reports $140,00 $145.600,00 13.16 Review of COV reports Supervision, review and follow-up of close-out visit (COV) reports CPM CO 80 reports $140,00 $11.200,00 13.17 Kick-off meeting Organization and attendance for 1 online kickoff meeting CPM SU 1 study $4.480,00 $4.480,00 14 QUALITY CONTROL $88.000,00 14.1 Protocol deviations Protocol deviation review and management QMA RE, TR, FU 100 deviations $220,00 $22.000,00 14.2 Audits and inspections Preparing/hosting/attending sponsor's audits and regulatory inspections at CRO/site QMA RE, TR, FU, CO 10 audit/inspect. $6.600,00 $66.000,00 15 ADMINISTRATION $151.200,00 15.1 Logistics and invoice management Travel logistics management. Invoice control support. ADM RE, TR, FU 42 months $3.600,00 $151.200,00
16 DATA MANAGEMENT $446.040,00 16.1 DMP Development of data management plan (DMP) CDM SU 1 study $3.600,00 $3.600,00 16.2 DVP Development of data validation plan (DVP) (including automatic query and edit check definition) CDM SU 1 study $3.600,00 $3.600,00 16.3 EDC specifications Development of EDC specifications (annotated CRF, variable definition according to CDASH, related documentation) CDM SU 1 study $5.400,00 $5.400,00 16.4 EDC completion guideline Development of EDC completion guideline CDM SU 1 study $720,00 $720,00 16.5 EDC build EDC build (forms, automatic query, and edit check implementation) (30 unique pages) CDM SU 1 study $13.500,00 $13.500,00 16.6 UAT EDC testing and validation (internal and external UAT) CDM SU 1 study $3.600,00 $3.600,00 16.7 EDC trainings EDC trainings to sites (teleconference) CDM SU 80 sites $270,00 $21.600,00 16.8 EDC changes EDC modifications during the course of the study CDM RE, TR, FU 6 modifications $720,00 $4.320,00 16.9 Data cleaning EDC data requests, review, and cleaning (manual queries to sites incluiding follow-up) CDM RE, TR, FU 300 subjects $540,00 $162.000,00 16.10 SAE reconciliation SAE reconciliation with safety database CDM RE, TR, FU 250 SAEs $90,00 $22.500,00 16.11 EDC helpdesk EDC system maintenance and technical support (helpdesk) CDM RE, TR, FU 3360 site-month $45,00 $151.200,00 16.12 Coding of AEs Coding of adverse events (10 per patient) CDM RE, TR, FU 3000 AEs $9,00 $27.000,00 16.13 Coding of CMs Coding of concomitant medications (5 per patient) CDM RE, TR, FU 1500 CMs $9,00 $13.500,00 16.14 Coding of MH Coding of medical history (5 per patient) CDM RE, TR, FU 1500 MHs $9,00 $13.500,00 17 STATISTICAL PROGRAMMING $109.600,00 17.1 Statistical analysis plan (SAP) Development of statistical analysis plan (SAP) SPR 1 plan $6.000,00 $6.000,00 17.2 SAS programming Development of SAS programming (includes TFL) SPR 1 study $25.000,00 $25.000,00 17.3 SDTM: Reading of documents SDTM: Reading of study documents SPR 1 study $400,00 $400,00 17.4 SDTM: Annotated CRF SDTM: Development of Annotated CRF SPR 1 study $4.000,00 $4.000,00 17.5 SDTM: Mapping specifications SDTM: Development of mapping specifications SPR 1 study $7.500,00 $7.500,00 17.6 SDTM: SAS programming SDTM: SAS programming SPR 1 study $9.000,00 $9.000,00 17.7 SDTM: Double programming SDTM: Double programming SPR 1 study $9.000,00 $9.000,00 17.8 SDTM: Data transfer SDTM: Data transfer SPR 1 study $400,00 $400,00 17.9 SDTM: Data validation SDTM: Data validation SPR 1 study $2.000,00 $2.000,00
17.10 SDTM: Study data review guide SDTM: Development of the study data review guide SPR 1 study $1.000,00 $1.000,00 17.11 SDTM: Define.xml SDTM: Development of Define.xml SPR 1 study $6.000,00 $6.000,00 17.12 ADaM: Reading of documents ADaM: Reading of study documents SPR 1 study $400,00 $400,00 17.13 ADaM: Annotated CRF ADaM: Development of Annotated CRF SPR 1 study $4.000,00 $4.000,00 17.14 ADaM: Mapping specifications ADaM: Development of mapping specifications SPR 1 study $7.500,00 $7.500,00 17.15 ADaM: SAS programming ADaM: SAS programming SPR 1 study $9.000,00 $9.000,00 17.16 ADaM: Double programming ADaM: Double programming SPR 1 study $9.000,00 $9.000,00 17.17 ADaM: Data transfer ADaM: Data transfer SPR 1 study $400,00 $400,00 17.18 ADaM: Data validation ADaM: Data validation SPR 1 study $2.000,00 $2.000,00 17.19 ADaM: Study data review guide ADaM: Development of the study data review guide SPR 1 study $1.000,00 $1.000,00 17.20 ADaM: Define.xml ADaM: Development of Define.xml SPR 1 study $6.000,00 $6.000,00 $13.133.040,00 CRO SERVICES TOTAL
PASS-THROUGH COSTS
Shipping: Physical files to sites
Electronic signatures (contracts and other documents)
Shipping: Tumor samples for central diagnosis
Biological sample shipping packages
Office supplies (files, paper, and printing) and communication costs during the study
Payment per enrolled patient to sites (hospital staff, tests, and procedure costs)
Research team and pharmacy start-up fees
Screen failures fees
Trial insurance policies
Site contract management fees
Ethics committee evaluation fees (initial submission)
Ethics committee evaluation fees (amendments)
Regulatory authority evaluation fee (initial submission)
Onsite qualification visits (travel costs)
Onsite initiation visits (travel costs)
Onsite routine monitoring visits (travel costs)
Onsite close-out visits (travel costs)
Drug distribution services for experimental drugs (central and local depots)
EDC system for data collection (usage license and hosting)
eTMF for document management (usage license and hosting)
eTMF for document management (initial configuration fee)
Drug safety platform for safety management (usage license and hosting)
RTSM system for randomization and trial supply management (usage license and hosting)
Imaging platform for DICOM image uploads and reviews (usage license and hosting) GRAND
$14.709.000,00 $27.842.040,00
No. Units Unit Type Price/Unit Total 1 80 shipments $40,00 $3.200,00 2 80 sites $15,00 $1.200,00 3 300 shipments $40,00 $12.000,00 4 300 subjects $30,00 $9.000,00 5 60 months $500,00 $30.000,00 6 300 subjects $40.000,00 $12.000.000,00 7 80 sites $5.000,00 $400.000,00 8 60 failures $2.000,00 $120.000,00 9 1 set $90.000,00 $90.000,00 10 80 sites $3.000,00 $240.000,00 11 6 evaluation $3.000,00 $18.000,00 12 36 amendments $600,00 $21.600,00 13 5 evaluations $5.000,00 $25.000,00 14 90 visits $400,00 $36.000,00 15 80 visits $400,00 $32.000,00 16 1040 visits $400,00 $416.000,00 17 80 visits $400,00 $32.000,00 18 1 study $500.000,00 $500.000,00 19 48 months $4.000,00 $192.000,00 20 48 months $3.500,00 $168.000,00 21 1 study $3.000,00 $3.000,00 22 48 months $2.500,00 $120.000,00 23 48 months $2.000,00 $96.000,00 24 48 months $3.000,00 $144.000,00
Description
TOTAL
TOTAL
PASS-THROUGH COSTS
COST SUMMARY
ETHICS/REGULATORY
SITE SELECTION
SITE INITIATION AND ACTIVATION
SITE MANAGEMENT
MONITORING
CLOSE-OUT
SAFETY
DRUG LOGISTICS
CLINICAL SUPPLIES LOGISTICS
FILES/DOCUMENT MANAGEMENT
MEDICAL WRITING
PROJECT MANAGEMENT
QUALITY CONTROL
ADMINISTRATION
DATA MANAGEMENT
STATISTICAL PROGRAMMING
SITE CONTRACTING AND PAYMENTS PASS-THROUGH COSTS
Notes:
Drug manufacturing costs not included. Translational study costs not included. All prices are shown in US dollars ($). This is a non-binding, unofficial sample quote just to be used as an example.
1 $214.200,00 2 $196.800,00 3 $193.160,00 4 $167.200,00 5 $3.801.600,00 6 $2.663.760,00 7 $202.400,00 8 $138.160,00 9 $271.780,00 10 $105.700,00 11 $560.000,00 12 $51.920,00 13 $3.771.520,00 14 $88.000,00 15 $151.200,00 16 $446.040,00 17 $109.600,00 $13.133.040,00 $14.709.000,00 $27.842.040,00
GRAND TOTAL
CRO SERVICES