CLINICAL TRIAL QUOTATION (PHASE 1 CLINICAL TRIAL IN SPAIN)
Client: 4 months Study title: 9 months Phase: 6 months Th. area: 12 months Subjects: 3 months Sites: 34 months Spain 8 2 32 8 No. Task Title Description Role Stage Units Unit Type Price/Unit Total 1 ETHICS/REGULATORY 16.740,00 € 1.1 Site document collection (submissions) Collection and preparation of site documents required for initial EC/RA submissions RSP SU 4 sites 540,00 € 2.160,00 € 1.2 Insurance (initial) Issuance of initial insurance policy RSP SU 1 policy 180,00 € 180,00 € 1.3 Insurance (updates) Insurance policy updates and/or renewals RSP SU 2 updates 90,00 € 180,00 € 1.4 EC submission Ethics committee (EC) initial application submission (preparation, submission, response to clarifications including requested changes) RSP SU 1 submission 3.600,00 € 3.600,00 € 1.5 RA submission Regulatory authority (RA) initial application submission via CTIS (preparation, submission, response to clarifications including requested changes) RSP SU 1 submission 3.600,00 € 3.600,00 € 1.6 EC/RA amendments Study amendments (including document changes and EC/RA approvals) RSP RE, TR, FU 3 amendments 1.080,00 € 3.240,00 € 1.7 EC/RA reporting EC and RA reporting (study initiation, first patient, APR, DSUR, close-out) RSP SU, RE, TR, FU, CO 9 communications 90,00 € 810,00 € 1.8 Site reporting Site reporting (study initiation, first patient, APR, DSUR, close-out) RSP SU, RE, TR, FU, CO 9 communications 90,00 € 810,00 € 1.9 APR (writing) Writing and review of annual progress report (APR) RSP RE, TR, FU, CO 3 reports 720,00 € 2.160,00 € 4 Study total: Biotech Company Phase 1 Oncology Clinical Trial with Drugs in Europe (Spain) 1 Oncology 15 4
CRO 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):
2 SITE CONTRACTING AND PAYMENTS 5.340,00 € 2.1 Site contracting Negotiation and execution of site contracts (including budgets) SCS SU 4 contracts 840,00 € 3.360,00 € 2.2 Site payments (start-up) Payments to sites related to start-up fees (contract, pharmacy, etc.) ADM SU 4 sites 55,00 € 220,00 € 2.3 Site payments (visits) Payments to sites related to patient fees (visit costs) ADM RE, TR, FU, CO 4 sites 440,00 € 1.760,00 € 3 SITE SELECTION 5.600,00 € 3.1 FQ development Writing and review of feasibility questionnaire (FQ) CRA SU 1 FQ 480,00 € 480,00 € 3.2 FQ collection Preparation, distribution, collection, and review of feasibility questionnaires (FQs) CRA SU 6 sites 240,00 € 1.440,00 € 3.3 Onsite SQV Onsite site qualification visit (SQV) (preparation, travel, visit, report, follow-up) SCRA SU 2 visits 1.200,00 € 2.400,00 € 3.4 Remote SQV Remote site qualification visit (SQV) (visit) SCRA SU 2 visits 640,00 € 1.280,00 € 4 SITE INITIATION AND ACTIVATION 4.800,00 € 4.1 Onsite SIV Onsite site initiation visit (SIV) (preparation, travel, visit, report, follow-up) SCRA SU 2 visits 1.280,00 € 2.560,00 € 4.2 Remote SIV Remote site initiation visit (SIV) (preparation, travel, visit, report, follow-up) SCRA SU 2 visits 800,00 € 1.600,00 € 4.3 Site activation Site activation (document verification and system access activation) SCRA SU 4 sites 160,00 € 640,00 € 5 SITE MANAGEMENT 67.200,00 € 5.1 Site management (RE, TR) Communication with sites to
support and solve doubts.
to
Recruitment helpdesk. Biological
Ensure trial is
to GCP. Ensure sites always have
SCRA RE, TR 60 site-month 800,00 € 48.000,00 €
provide
Respond
all site inquiries.
sample management support. Review site performance and escalate any infringements.
conducted according
updated documentation.
Site management (FU) Communication with sites to provide support and solve doubts. Respond to all site inquiries. Recruitment helpdesk. Biological sample management support. Review site performance and escalate any infringements. Ensure trial is conducted according to GCP. Ensure sites always have updated documentation.
5.2
SCRA FU 48 site-month 400,00 € 19.200,00 € 6 MONITORING 75.840,00 € 6.1 CRA trainings (initial) Initial review of study documents and system trainings SCRA SU 1 study 1.280,00 € 1.280,00 € 6.2 CRA trainings (subsequent) Subsequent training sessions during the study SCRA RE, TR, FU 1 study 2.560,00 € 2.560,00 € 6.3 Onsite IMV (RE, TR) Onsite interim monitoring visit (IMV) during recruitment and treatment (preparation, travel, visit, report, follow-up) SCRA RE, TR 32 visits 1.680,00 € 53.760,00 € 6.4 Onsite IMV (FU) Onsite interim monitoring visit (IMV) during follow-up (preparation, travel, visit, report, follow-up) SCRA FU 8 visits 1.680,00 € 13.440,00 € 6.5 Data reviews Remote review of EDC clinical data and query management SCRA RE, TR, FU 15 subjects 320,00 € 4.800,00 € 7 CLOSE-OUT 7.360,00 € 7.1 Onsite COV Onsite close-out visit (COV) (preparation, travel, visit, report, follow-up) SCRA CO 4 visits 1.840,00 € 7.360,00 € 8 SAFETY 12.160,00 € 8.1 Safety database setup Initial configuration and setup of safety database SCRA SU 1 study 1.920,00 € 1.920,00 € 8.2 SAE management Receipt, review, listing, and follow-up of SAEs including reporting to Sponsor and/or Medical Monitor SCRA RE, TR, FU 10 SAEs 320,00 € 3.200,00 € 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 2 SUSARs 640,00 € 1.280,00 € 8.4 DSUR (writing) Writing and review of annual safety report (DSUR) SCRA RE, TR, FU 3 reports 1.920,00 € 5.760,00 € 9 DRUG LOGISTICS 5.320,00 € 9.1 Depot contracting Drug depot selection and contracting CPM SU 1 contract 1.360,00 € 1.360,00 €
9.2 Drug shipments to depot Communication with drug manufacturer for the shipment of drug to depot CRA RE, TR 2 shipments 180,00 € 360,00 € 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. CRA RE, TR 60 site-month 60,00 € 3.600,00 € 10 CLINICAL SUPPLIES LOGISTICS 2.585,00 € 10.1 Purchasing of clinical supplies Purchasing of kit components (tubes, bags, etc.) CTA SU, RE, TR 2 orders 55,00 € 110,00 € 10.2 Kit preparation Preparation of clinical supplies (lab kits) including shipments CTA SU, RE, TR 15 kits 55,00 € 825,00 € 10.3 Kit tracking Ongoing tracking of clinical supplies (lab kits) at sites CTA RE, TR 60 site-month 27,50 € 1.650,00 € 11 FILES/DOCUMENT MANAGEMENT 35.200,00 € 11.1 TMF setup Initial configuration and setup of TMF CTA SU 1 study 2.200,00 € 2.200,00 € 11.2 TMF maintenance TMF maintenance during entire study conduct CTA RE, TR, FU 136 site-month 165,00 € 22.440,00 € 11.3 TMF reconciliation Final reconciliation of TMF to ensure completion CTA CO 4 sites 880,00 € 3.520,00 € 11.4 ISF preparation Investigator Site File (ISF) preparation and shipment to sites CTA SU 4 sites 110,00 € 440,00 € 11.5 Document management Management of other documents (as needed) CTA RE, TR, FU, CO 30 months 220,00 € 6.600,00 € 12 MEDICAL WRITING 28.080,00 € 12.1 Protocol writing Writing and review of full study protocol MWR SU 1 protocol 7.200,00 € 7.200,00 € 12.2 Protocol synopsis translation Translation and review of protocol synopsis MWR SU 1 synopsis 360,00 € 360,00 € 12.3 PIS/ICF writing Writing, translation, adaptation, and review of PIS/ICF MWR SU 1 PIS/ICF 720,00 € 720,00 € 12.4 Abstract writing Writing and review of abstract MWR CO 1 abstract 360,00 € 360,00 € 12.5 Poster writing Writing and review of poster MWR CO 1 poster 1.440,00 € 1.440,00 € 12.6 Manuscript writing Writing and review of manuscript MWR CO 1 manuscript 7.200,00 € 7.200,00 € 12.7 CSR writing Writing and review of clinical study report (CSR) MWR CO 1 report 10.800,00 € 10.800,00 €
13 PROJECT MANAGEMENT 229.270,00 € 13.1 CPM trainings (initial) Initial review of study documents and system trainings CPM SU 1 study 1.360,00 € 1.360,00 € 13.2 CPM trainings (subsequent) Subsequent training sessions during the study CPM SU 1 study 2.720,00 € 2.720,00 € 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 2.040,00 € 10.200,00 € 13.4 CPM internal meetings (SU, RE, TR) Internal meetings (4 TC per month) CPM SU, RE, TR 76 TCs 85,00 € 6.460,00 € 13.5 CPM internal meetings (FU, CO) Internal meetings (1 TC per month) CPM FU, CO 15 TCs 85,00 € 1.275,00 € 13.6 CPM Sponsor meetings (SU, RE, TR) Regular meetings with the Sponsor (4 TC per month) CPM SU, RE, TR 76 TCs 85,00 € 6.460,00 € 13.7 CPM Sponsor meetings (FU, CO) Regular meetings with the Sponsor (1 TC per month) CPM FU, CO 15 TCs 85,00 € 1.275,00 € 13.8 CRA internal meetings (SU, RE, TR) Internal meetings (4 TC per month) SCRA SU, RE, TR 76 TCs 80,00 € 6.080,00 € 13.9 CRA internal meetings (FU, CO) Internal meetings (1 TC per month) SCRA FU, CO 15 TCs 80,00 € 1.200,00 € 13.10 CRA Sponsor meetings (SU, RE, TR) Regular meetings with the Sponsor (4 TC per month) SCRA SU, RE, TR 76 TCs 80,00 € 6.080,00 € 13.11 CRA Sponsor meetings (FU, CO) Regular meetings with the Sponsor (1 TC per month) SCRA FU, CO 15 TCs 80,00 € 1.200,00 € 13.12 Study management (SU, RE, TR) Management of the study within project timelines and planned budget. Study financial management and supervision of study costs. Vendor management. Escalate and solve study issues and deviations. Respond to all Sponsor inquiries. Newsletters during recruitment. CPM SU, RE, TR 19 months 6.800,00 € 129.200,00 € 13.13 Study management (FU, CO) Management of the study within project timelines and planned budget. Study financial management and supervision of study costs. Vendor management. Escalate and solve study issues and deviations. Respond to all Sponsor inquiries. CPM FU, CO 15 months 3.400,00 € 51.000,00 €
13.14 Review of SIV reports Supervision, review and follow-up of site initiation visit (SIV) reports CPM SU 4 reports 85,00 € 340,00 € 13.15 Review of IMV reports Supervision, review and follow-up of interim monitoring visit (IMV) reports CPM RE, TR, FU 32 reports 85,00 € 2.720,00 € 13.16 Review of COV reports Supervision, review and follow-up of close-out visit (COV) reports CPM CO 4 reports 85,00 € 340,00 € 13.17 Kick-off meeting Organization and attendance for 1 online kickoff meeting CPM SU 1 study 1.360,00 € 1.360,00 € 14 QUALITY CONTROL 12.600,00 € 14.1 Protocol deviations Protocol deviation review and management QMA RE, TR, FU 10 deviations 180,00 € 1.800,00 € 14.2 Audits and inspections Preparing/hosting/attending sponsor's audits and regulatory inspections at CRO/site QMA RE, TR, FU, CO 2 audit/inspect. 5.400,00 € 10.800,00 € 15 ADMINISTRATION 7.425,00 € 15.1 Logistics and invoice management Travel logistics management. Invoice control support. ADM RE, TR, FU 27 months 275,00 € 7.425,00 € 16 DATA MANAGEMENT 39.060,00 € 16.1 DMP Development of data management plan (DMP) CDM SU 1 study 2.800,00 € 2.800,00 € 16.2 DVP Development of data validation plan (DVP) (including automatic query and edit check definition) CDM SU 1 study 2.800,00 € 2.800,00 € 16.3 EDC specifications Development of EDC specifications (annotated CRF, variable definition according to CDASH, related documentation) CDM SU 1 study 4.200,00 € 4.200,00 € 16.4 EDC completion guideline Development of EDC completion guideline CDM SU 1 study 560,00 € 560,00 € 16.5 EDC build EDC build (forms, automatic query, and edit check implementation) (30 unique pages) CDM SU 1 study 10.500,00 € 10.500,00 € 16.6 UAT EDC testing and validation (internal and external UAT) CDM SU 1 study 2.800,00 € 2.800,00 € 16.7 EDC trainings EDC trainings to sites (teleconference) CDM SU 4 sites 210,00 € 840,00 € 16.8 EDC changes EDC modifications during the course of the study CDM RE, TR, FU 3 modifications 560,00 € 1.680,00 € 16.9 Data cleaning EDC data requests, review, and cleaning (manual queries to sites incluiding follow-up) CDM RE, TR, FU 15 subjects 420,00 € 6.300,00 € 16.10 SAE reconciliation SAE reconciliation with safety database CDM RE, TR, FU 10 SAEs 70,00 € 700,00 € 16.11 EDC helpdesk EDC system maintenance and technical support (helpdesk) CDM RE, TR, FU 108 site-month 35,00 € 3.780,00 € 16.12 Coding of AEs Coding of adverse events (10 per patient) CDM RE, TR, FU 150 AEs 7,00 € 1.050,00 €
16.13 Coding of CMs Coding of concomitant medications (5 per patient) CDM RE, TR, FU 75 CMs 7,00 € 525,00 € 16.14 Coding of MH Coding of medical history (5 per patient) CDM RE, TR, FU 75 MHs 7,00 € 525,00 € 17 STATISTICAL PROGRAMMING 75.320,00 € 17.1 Statistical analysis plan (SAP) Development of statistical analysis plan (SAP) SPR 1 plan 2.800,00 € 2.800,00 € 17.2 SAS programming Development of SAS programming (includes TFL) SPR 1 study 17.500,00 € 17.500,00 € 17.3 SDTM: Reading of documents SDTM: Reading of study documents SPR 1 study 280,00 € 280,00 € 17.4 SDTM: Annotated CRF SDTM: Development of Annotated CRF SPR 1 study 2.800,00 € 2.800,00 € 17.5 SDTM: Mapping specifications SDTM: Development of mapping specifications SPR 1 study 5.250,00 € 5.250,00 € 17.6 SDTM: SAS programming SDTM: SAS programming SPR 1 study 6.300,00 € 6.300,00 € 17.7 SDTM: Double programming SDTM: Double programming SPR 1 study 6.300,00 € 6.300,00 € 17.8 SDTM: Data transfer SDTM: Data transfer SPR 1 study 280,00 € 280,00 € 17.9 SDTM: Data validation SDTM: Data validation SPR 1 study 1.400,00 € 1.400,00 € 17.10 SDTM: Study data review guide SDTM: Development of the study data review guide SPR 1 study 700,00 € 700,00 € 17.11 SDTM: Define.xml SDTM: Development of Define.xml SPR 1 study 4.200,00 € 4.200,00 € 17.12 ADaM: Reading of documents ADaM: Reading of study documents SPR 1 study 280,00 € 280,00 € 17.13 ADaM: Annotated CRF ADaM: Development of Annotated CRF SPR 1 study 2.800,00 € 2.800,00 € 17.14 ADaM: Mapping specifications ADaM: Development of mapping specifications SPR 1 study 5.250,00 € 5.250,00 € 17.15 ADaM: SAS programming ADaM: SAS programming SPR 1 study 6.300,00 € 6.300,00 € 17.16 ADaM: Double programming ADaM: Double programming SPR 1 study 6.300,00 € 6.300,00 € 17.17 ADaM: Data transfer ADaM: Data transfer SPR 1 study 280,00 € 280,00 € 17.18 ADaM: Data validation ADaM: Data validation SPR 1 study 1.400,00 € 1.400,00 € 17.19 ADaM: Study data review guide ADaM: Development of the study data review guide SPR 1 study 700,00 € 700,00 € 17.20 ADaM: Define.xml ADaM: Development of Define.xml SPR 1 study 4.200,00 € 4.200,00 € 629.900,00 € CRO SERVICES TOTAL
PASS-THROUGH COSTS
Description
Shipping: Physical files to sites
Electronic signatures (contracts and other documents)
Shipping: Tumor samples for central diagnosis and translational study
Shipping: Blood samples for translational study (ambient temperature)
Shipping: Frozen blood samples to central laboratories
Blood tubes and 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)
Trial insurance policy
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 depot)
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)
PASS-THROUGH COSTS TOTAL
GRAND TOTAL
No. Units Unit Type Price/Unit Total 1 4 shipments 30,00 € 120,00 € 2 4 sites 15,00 € 60,00 € 3 30 shipments 25,00 € 750,00 € 4 60 shipments 25,00 € 1.500,00 € 5 4 sites 1.000,00 € 4.000,00 € 6 15 subjects 70,00 € 1.050,00 € 7 34 months 50,00 € 1.700,00 € 8 15 subjects 11.000,00 € 165.000,00 € 9 1 policy 6.000,00 € 6.000,00 € 10 4 sites 3.000,00 € 12.000,00 € 11 1 evaluation 2.500,00 € 2.500,00 € 12 3 amendments 500,00 € 1.500,00 € 13 1 evaluation 4.500,00 € 4.500,00 € 14 2 visits 250,00 € 500,00 € 15 2 visits 250,00 € 500,00 € 16 32 visits 250,00 € 8.000,00 € 17 4 visits 250,00 € 1.000,00 € 18 1 study 40.000,00 € 40.000,00 € 19 30 months 1.100,00 € 33.000,00 € 20 30 months 1.000,00 € 30.000,00 € 21 1 study 2.500,00 € 2.500,00 € 22 30 months 900,00 € 27.000,00 € 343.180,00 € 973.080,00 €
COST SUMMARY
ETHICS/REGULATORY
SITE CONTRACTING AND PAYMENTS
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
Notes:
Drug manufacturing costs not included.
Translational study costs not included.
All prices are shown in Euros (€).
This is a non-binding, unofficial sample quote just to be used as an example.
1 16.740,00 € 2 5.340,00 € 3 5.600,00 € 4 4.800,00 € 5 67.200,00 € 6 75.840,00 € 7 7.360,00 € 8 12.160,00 € 9 5.320,00 € 10 2.585,00 € 11 35.200,00 € 12 28.080,00 € 13 229.270,00 € 14 12.600,00 € 15 7.425,00 € 16 39.060,00 € 17 75.320,00 € 629.900,00 € 343.180,00 € 973.080,00 €
GRAND TOTAL
CRO SERVICES
PASS-THROUGH COSTS
