Estimated Project Budget. Unit # Cost Fees Estimated Estimated Services Unit Units (A$) (A$) Pass-Thru (A$) Total Cost (A$) CLINICAL DATA MANAGEMENT • Clinical Data Management Oversight — Int’l (CDM Manager assumes ****% FTE) Days **** **** **** **** **** • Lead CDA — Int’l (assumes ****% FTE for **** months) Days **** **** **** **** **** • Development of Data Management Plan (includes **** major and **** minor revision; add’l revisions, will be billed at per diem rates) Days **** **** **** **** **** • Database Development, Testing and Maintenance (assumes **** page CRF, ****) unique CRF-pages Project **** **** **** **** **** • Estimated Data Entry (actual will be bi1led) Pages **** **** **** **** **** • Estimated Data Review and Query Resolution (assumes **** issue per **** CRF pages, **** manual checks and the application of **** study assumption for **** CRF pages); assumes **** CRF pages per enrolled patient, **** pages per screen failure patient, and **** pages per drop out patient. Queries will be billed on actuals. Page **** **** **** **** **** • Quality Control Check of Database versus CRF (assumes **** CRF pages per patient) Patient **** **** **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. # Unit Cost Fees Estimated Estimated Services Unit Units (A$) (A$) Pass-Thru (A$) Total Cost (A$) CLINICAL DATA MANAGEMENT (continued) • Quality Control Check of Database versus CRF critical variables Patient **** **** **** **** **** • Edit Development (actuals will be billed) Edits **** **** **** **** **** • CRF and Query Tracking (includes all ancillary pages; actuals will be billed) Page **** **** **** **** **** • Dictionary Coding of Adverse Event terms to MedDRA (estimated to be **** per patient; actuals will be billed) Term **** **** **** **** **** • Dictionary Coding of Medication Terms (estimated to be **** per patient; actuals will be billed) Term **** **** **** **** **** • External Vendor — Initial Load (actuals will be billed) **** >Initial Load Load **** **** **** **** **** >Subsequent Load (actuals will be billed) Monthly **** **** **** **** **** >Lab Visit Verification (**** visits x 60 patients; actuals will be billed) Visits **** **** **** **** **** • Reconciliation of the safety and Clinical Database (assumes ****% SAEs; actuals will be billed) SAE **** **** **** **** Subtotal – Clinical Data Management **** **** **** BIOMETRICS • Biometrics Team Manager Days **** **** **** **** **** • Project Data Setup Project **** **** **** **** **** • Statistical Plan Project **** **** **** **** **** • Design of Table Shells (Mocks) Project **** **** **** **** **** • Programming/QC of Data Displays (actuals will be billed) Unique Tables Table **** **** **** **** **** Repeat Tables Table **** **** **** **** **** Unique Listings Listing **** **** **** **** **** Repeat Listings Listing **** **** **** **** **** Unique Figures Figure **** **** **** **** **** Repeat Figures Figure **** **** **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. # UnitCost Fees Estimated Estimated Services Unit Units (A$) (A$) Pass-Thru (A$) Total Cost (A$) BIOMETRICS (continued) • Programmatic Evaluability/Outcome Project **** **** **** **** **** • Statistical Analysis Project **** **** **** **** **** • FDA Item 11 (if required) Project **** **** **** **** **** • Standard Data Transfer > Initial Transfer **** **** **** **** **** > Subsequent Transfer **** **** **** **** **** Add’l Stats consulting, meeting attendance, etc., will be charged at per diem rates as follows: Team Leader Days **** Statistician Days **** Programmer Days **** Subtotal — Biometrics **** **** **** CLINICAL WRITING • Clinical Study Report Phase 11 (Report includes **** major (up to **** days) and **** minor (up to **** day) revision; does not include compilation of Clinical Study Report Appendices; per Omnicare SOPs) Report **** **** **** **** **** • Narratives (actuals will be billed) Narrative **** **** **** **** **** • Clinical Writing Input to SAP Project **** **** **** **** **** • Sponsor Meeting Attendance (billed on actuals; Senior Writer International) Days **** **** **** **** **** Attendance at Sponsor Requested Meetings: Attendances Sponsor requested meetings (teleconferences/video conferences or client review/planning meeting at Sponsor/Omnicare CR, Inc.) will be billed to Sponsor according to the following per diem rates: Director Days **** Senior Writer Days **** Clinical Writer Days **** Sponsor will be billed for actual time expended. Subtotal — Clinical Writing **** **** **** MISCELLANEOUS • Return of CRF (hard copy); bxxx on actuals Pages **** **** **** **** **** Subtotal - Miscellaneous **** **** **** Estimated Services Budget **** Estimated Pass Through **** Total Estimated Budget **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Appears in 1 contract
Samples: Change (Peplin Inc)
Estimated Project Budget. Unit Service Estimated Estimated # Cost Fees Estimated Estimated Pass-Thru Total cost Services Unit Units (A$) (A$) Pass-Thru (A$) Total Cost (A$) CLINICAL DATA AUD AUD AUD AUD STUDY MANAGEMENT • Project Leader / Clinical Data Management Oversight Trial Manager — Int’l Australia (CDM Manager assumes **** days per month for *% FTE*** months) Days **** **** **** **** **** • Project Administrative Support/Coordination —Australia (includes support for all functional areas) Days **** **** **** **** **** Subtotal — Study Management **** **** **** CLINICAL TRIAL INITIATION • Study Master File (America; **** site for **** months) Site Months **** **** **** **** **** • Regulatory Document Collection (US) Site **** **** **** **** **** Local IRB (pass-throughs are estimates only; actual fees will be billed based on specific IRB fees) Site **** **** **** **** **** • Protocol Amendments excluding ICF change (US) Amendments/ site **** **** **** **** **** • Protocol Amendments including ICF change (US) Amendments/ site **** **** **** **** **** • IND Safety Report (US) Reports/Site **** **** **** **** **** • Investigator Brochure Updates (US) IB Updates/ Site **** **** **** **** **** • CRA Training Hours **** **** **** **** **** Subtotal — Clinical Trial Initiation **** **** **** CLINICAL TRIAL MANAGEMENT • Clinical Monitoring >Site Qualification Visit (US): **** hrs on-site, **** hrs for prep, follow-up, and reports, and **** hrs for travel — IF REQUIRED (actual units provided will be billed) Visit **** **** **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Unit Service Estimated Estimated # Cost Fees Pass-Thru Total cost Services Unit Units AUD AUD AUD AUD >Site Initiation Visit (US): **** hrs on-site, **** hrs for prep follow-up, and reports, and **** hrs for travel Visit **** **** **** **** **** > Clinical Trial Manager Training at Site Initiation Visit Days **** **** **** **** **** >Site Interim Visits (US): assume **** visits/site, **** hrs on-site, **** hrs for prep, follow-up, and reports, and **** hrs for travel: ****-weekly visits Visits **** **** **** **** **** >Additional Day Interim Visits (IF REQUIRED; based on **** hours per day) Visit **** **** **** **** **** >Site Close-Out Visit (US): **** hrs on-site, **** hrs for prep, follow-up, and reports, and **** hrs for travel Visits **** **** **** **** **** • Site Maintenance for **** hrs/month/site (**** site in the US x **** months) Site Months **** **** **** **** **** • Project Team Training (to be held in Omnicare CR’s Sydney offices) >CTM — Australia Days **** **** **** **** **** > Medical Monitor—Australia Days **** **** **** **** **** >Safety Officers — US (Via teleconference) Days **** **** **** **** **** Statistician: Australia **** **** **** **** **** • Sponsor Meeting Attendance (billed on actuals) by Project Leader/clinical Trial Manager (professional fees included in Study Management; pass-through expenses are included as it assumes some travel to Queensland for face-to-face meetings) Days **** **** **** **** **** Subtotal — Clinical Trial Management **** **** **** MEDICAL AND SAFETY • Medical Monitoring, including does escalation, availability during business hours in Australia (actual hours expended will be billed) Hours **** **** **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Unit Service Estimated Estimated # Cost Fees Pass-Thru Total cost Services Unit Units AUD AUD AUD AUD • Medical Monitoring availability out of business hours, between 6pm and 8am in Australia (actual hours expended will be billed) Hours **** **** **** **** **** • Protocol Review by Medical Monitor plus project specific forms/ plan completed etc.(Australia) Project **** **** **** **** **** • Medical Consulting requested in Australia Hours **** **** **** **** **** • Safety Plan and Master File Set Up Site **** **** **** **** **** • Safety Phone Cover (actuals months will be billed) Months **** **** **** **** **** • Global Safety Coordinator in the US (assumes **** day per month for **** months) Days **** **** **** **** **** • SAE Reporting (with narratives) Billed on actuals Reports **** **** **** **** **** • Dear Dr Letters reporting Pls who report to IEC, tracking of IRB acknowledgement letter Letter **** **** **** **** **** • SAE Reporting (Follow-up/Revision Reports >****) Billed on actuals Report **** **** **** **** **** Subtotal— Medical and Safety **** **** **** CLINICAL DATA MANAGEMENT • Lead CDA — Int’l Americas (assumes ****% FTE for x **** months Startup, ****% FTE x **** months, and ****% FTE x **** months Close-out) Days **** **** **** **** **** • Development of Data Management Plan (includes **** major and **** minor revision; add’l revisions, add **** revisions will be billed at per diem rates) Days **** **** **** **** **** • CRF Design (assumes **** page CRF, **** unique CRF pages); includes **** major and **** minor revision Project **** **** **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Unit Service Estimated Estimated # Cost Fees Pass-Thru Total cost Services Unit Units AUD AUD AUD AUD • Database Development, Testing and Maintenance (assumes **** page CRF, ***** unique CRF pages) unique CRF-pages Project **** **** **** **** **** • Estimated Data Entry (actual actuals will be bi1ledbilled) — Pages in US Pages **** **** **** **** **** • Estimated Data Review and Query Resolution (assumes **** issue per **** CRF pages, **** manual checks and the application of **** study assumption for **** CRF pages); assumes **** CRF pages per enrolled patient, **** pages per screen failure patient, and **** pages per drop out patient. Queries will be billed on actuals. Page actuals (Based on issues) Issue **** **** **** **** **** • Quality Control Check of Database versus CRF (assumes **** CRF pages per patient) Patient Page **** **** **** **** **** • Edit Development (actuals Will be billed) Edits **** **** **** **** **** • Dictionary Coding of Adverse Event terms to MedDRA (estimated to be per patient; actuals will be billed) Term **** **** **** **** **** • Dictionary Coding of Medication, Terms (estimated to be **** per patient; actuals will be billed) Term **** **** **** **** **** • Dictionary Coding of Medical History (estimated to be **** per patient; actuals will be billed) Term **** **** **** **** **** • PK Laboratory Data >Initial Load Project **** **** **** **** >Subsequent Loading (actuals will be billed) Load **** **** **** **** >Lab Header Visit Verification (**** visits x **** patients; actuals will be billed) Visits **** **** **** **** • Reconciliation of the Safety and Clinical Database (actuals will be billed) SAE **** **** **** **** Subtotal — Clinical Data Management **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Unit Service Estimated Estimated # Unit Cost Fees Estimated Estimated Pass-Thru Total cost Services Unit Units (A$) (A$) Pass-Thru (A$) Total Cost (A$) CLINICAL DATA MANAGEMENT (continued) • Quality Control Check of Database versus CRF critical variables Patient **** **** **** **** **** • Edit Development (actuals will be billed) Edits **** **** **** **** **** • CRF and Query Tracking (includes all ancillary pages; actuals will be billed) Page **** **** **** **** **** • Dictionary Coding of Adverse Event terms to MedDRA (estimated to be **** per patient; actuals will be billed) Term **** **** **** **** **** • Dictionary Coding of Medication Terms (estimated to be **** per patient; actuals will be billed) Term **** **** **** **** **** • External Vendor — Initial Load (actuals will be billed) **** >Initial Load Load **** **** **** **** **** >Subsequent Load (actuals will be billed) Monthly **** **** **** **** **** >Lab Visit Verification (**** visits x 60 patients; actuals will be billed) Visits **** **** **** **** **** • Reconciliation of the safety and Clinical Database (assumes ****% SAEs; actuals will be billed) SAE **** **** **** **** Subtotal – Clinical Data Management **** **** **** AUD AUD AUD AUD BIOMETRICS ANALYSIS • Biometrics Team Manager Leader Days **** **** **** **** **** • Project Data Setup Project Statistical Consultation as requested Hours **** **** **** **** **** • Statistical Plan Project **** **** **** **** **** • Design of Table Shells (Mocks) + Mocks Project **** **** **** **** **** • Programming/QC of Data Displays (actuals will be billed) ). > Unique Tables Table **** **** **** **** **** >Repeat Tables Table **** **** **** **** **** > Unique Listings Listing **** **** **** **** **** >Repeat Listings Listing **** **** **** **** **** Unique Figures Figure **** **** **** **** **** Repeat Figures Figure **** **** **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. # UnitCost Fees Estimated Estimated Services Unit Units (A$) (A$) Pass-Thru (A$) Total Cost (A$) BIOMETRICS (continued) • Programmatic Evaluability/Outcome Project **** **** **** **** **** • Statistical Analysis Project **** **** **** **** **** • FDA Item 11 (if requiredReg.) Project **** **** **** **** **** • Statistical Report (Regular) Project **** **** **** **** **** Standard Data Transfer > >Initial Transfer **** **** **** **** **** > >Subsequent (if required) Transfer **** **** **** **** **** Add’l Stats consulting, meeting attendance, etc., will be charged at per diem rates as follows: Team Leader Days **** Statistician Days **** Programmer Days **** Subtotal — Biometrics Analysis **** **** **** CLINICAL WRITING • Clinical Study Report Phase 11 (Report > includes **** major revision (up to **** days) and **** minor (up to **** day) revision; revision >Per Omnicare CR’s SOPS >Fee does not include compilation of Clinical Study Report Appendices; per Omnicare SOPs) CSR appendices Report **** **** **** **** **** • Narratives Narrative (actuals will be billed) Narrative **** **** **** **** **** • Clinical Writing Input to SAP Project **** **** **** **** **** • Sponsor Meeting Attendance (billed on actualsSenior Writer; Senior Writer Internationalactuals will be billed) Days **** **** **** **** **** Attendance at Sponsor Requested Meetings: Attendances Attendance at Sponsor requested meetings (teleconferences/video conferences or client Sponsor review/planning meeting meetings at Sponsor/Omnicare CR, Inc.) will be billed to Sponsor according to the following per diem rates: Director Days Director: **** Senior Writer Days Writer: **** Clinical Writer Days Writer: **** Sponsor will be billed for actual time expended. expended Subtotal — Clinical Writing **** **** **** MISCELLANEOUS • Return of CRF (hard copy); bxxx on actuals Pages **** **** **** **** **** Subtotal - Miscellaneous **** **** **** Estimated Services Budget **** Estimated Pass Through **** Total Estimated Budget **** REGULATORY SERVICES **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.. Unit Service Estimated Estimated # Cost Fees Pass-Thru Total cost Services Unit Units AUD AUD AUD AUD • CRF Filing and Reconciliation (bxxx on actuals) Pages **** **** **** **** **** • Return of CRF (hard copy); bxxx on actuals Pages **** **** **** **** **** • Return of Investigator and Study-Wide Documents (paper) Sites **** **** **** **** **** Subtotal — Regulatory Services **** **** **** CLINICAL QUALITY ASSURANCE • Quality Plan Days **** **** **** **** **** • CQA Site Audits — includes preparation and travel time, audit time, audit follow-up, and Audit Report and Audit Certificate generation at **** site in the US Sites **** **** **** **** **** Subtotal — Clinical Quality Assurance **** **** **** MISCELLANEOUS PASS-THROUGH EXPENSES • CRF Printing (bxxx on actuals) Pages **** **** **** Subtotal — Miscellaneous PT Expenses **** **** Estimated Services Budget **** Estimated Pass Through **** Total Estimated Budget ****
Appears in 1 contract
Samples: Change (Peplin Inc)
Estimated Project Budget. Unit Estimated Estimated # Cost Fees Estimated Estimated Pass-Thru Total Cost Services Unit Units (A$) Fees (A$) Pass-Thru (A$) Total Cost (A$) CLINICAL DATA MANAGEMENT • Clinical Data Management Oversight — Int’l (CDM Manager assumes ****% FTEFTE x **** month for Start-up, ****% FTE for **** months for Duration, and ****% FTE for **** months for Close-out) Days **** **** **** **** **** • Lead CDA — Int’l (assumes ****% FTE x **** month for Start-up, ****% FTE for **** monthsmonths for Duration and ****% FTE for **** months for Close-out) —Actual days will be billed Days **** **** **** **** **** • Development of Data Management Plan (includes **** major and **** minor revision; add’l revisions, revisions will be billed at per diem rates) Days **** **** **** **** **** • Database Development, Testing and Maintenance (assumes **** page CRF, ***** unique CRF pages) unique CRF-pages Project **** **** **** **** **** • Estimated Data Entry (actual actuals will be bi1ledbilled) Pages **** **** **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Unit Estimated Estimated # Cost Pass-Thru Total Cost Services Unit Units (A$) Fees (A$) (A$) (A$) CLINICAL DATA MANAGEMENT (continued) • Estimated Data Review and Query Resolution (assumes **** issue per **** CRF pages, **** manual checks and the application of **** study assumption for **** CRF pages); assumes **** CRF pages per enrolled patient, **** pages per screen failure patient, and **** pages per drop out patient. Queries Based on number of CRF Pages, actuals will be billed on actuals. Page **** **** **** **** **** • Quality Control Check of Database versus CRF (assumes **** CRF pages per patient) Patient **** **** **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. # Unit Cost Fees Estimated Estimated Services Unit Units (A$) (A$) Pass-Thru (A$) Total Cost (A$) CLINICAL DATA MANAGEMENT (continued) • Quality Control Check of Database versus CRF critical variables (**** minutes/patient) Patient **** **** **** **** **** • Edit Development (actuals will be billed) Edits **** **** **** **** **** • CRF and Query Tracking (includes all ancillary pages; actuals will be billed) Page **** **** **** **** **** • Dictionary Coding of Adverse Event terms to MedDRA (estimated to be **** per patient; actuals will be billed) Term **** **** **** **** **** • Dictionary Coding of Medication Terms (estimated to be **** per patient; actuals will be billed) Term **** **** **** **** **** • External Vendor Vendor) — Initial Load (actuals will be billed) **** >Initial Load Load **** **** **** **** **** >Subsequent Load (actuals will be billed) Monthly **** **** **** **** **** >Lab Visit Verification (**** visits x 60 patients; patient’s: actuals will be billed) Visits **** **** **** **** **** • Reconciliation of the safety Safety and Clinical Database (assumes ****% SAEs; actuals will be billed) SAE **** **** **** **** **** Subtotal – — Clinical Data Management **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Unit Estimated Estimated # Cost Pass-Thru Total Cost Services Unit Units (A$) Fees (A$) (A$) (A$) BIOMETRICS • Biometrics Team Manager (includes Project Management) Days **** **** **** **** **** • Project Data Setup Project **** **** **** **** **** • Statistical Plan Project **** **** **** **** **** • Design of Table Shells (Mocks) Project **** **** **** **** **** • Programming/QC of Data Displays (actuals will be billed) ). Unique Tables Table **** **** **** **** **** Repeat Tables Table **** **** **** **** **** Unique Listings Listing **** **** **** **** **** Repeat Listings Listing **** **** **** **** **** Unique Figures Figure **** **** **** **** **** Repeat Figures Figure **** **** **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. # UnitCost Fees Estimated Estimated Services Unit Units (A$) (A$) Pass-Thru (A$) Total Cost (A$) BIOMETRICS (continued) • Programmatic Evaluability/Outcome Project **** **** **** **** **** • Statistical Analysis Project **** **** **** **** **** • Statistical Report (Top Line Stats Summary Report) Project **** **** **** **** **** • FDA Item 11 (if required) Project **** **** **** **** **** • Standard Data Transfer > >Initial Transfer **** **** **** **** **** > >Subsequent Transfer **** **** **** **** **** Add’l Stats consulting, meeting attendance, etc., will be charged at per diem rates as follows: Team Leader Days **** Statistician Days **** Programmer Days **** Subtotal — Biometrics **** **** **** CLINICAL WRITING • Clinical Study Report - Phase 11 (Report II; includes **** major (up to **** days) ), and **** minor (up to **** day) revision; : does not include compilation of Clinical Study Report Appendices; per Omnicare CR SOPs) Report **** **** **** **** **** • Narratives (actuals will be billed) Narrative **** **** **** **** **** • Clinical Writing Input to SAP Project **** **** **** **** **** • Sponsor Meeting Attendance (billed on actuals; Senior Writer International) Days **** **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Unit Estimated Estimated # Cost Pass-Thru Total Cost Services Unit Units (A$) Fees (A$) (A$) (A$) CLINICAL WRITING (continued) Attendance at Sponsor Requested Meetings: Attendances Sponsor will be billed for actual time expended. Attendance at Sponsor requested meetings (teleconferences/video conferences or client review/planning meeting meetings at Sponsor/Omnicare CR, Inc.) will be billed to Sponsor according to the following per diem rates: Director Days **** Senior Writer Days **** Clinical Writer Days **** Sponsor will be billed for actual time expended. Subtotal — Clinical Writing **** **** **** MISCELLANEOUS • Return of CRF (hard copy); bxxx on actuals Pages **** **** **** **** **** Subtotal - — Miscellaneous **** **** **** Estimated Services Budget **** Estimated Pass Through **** Total Estimated Budget **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Appears in 1 contract
Samples: Change (Peplin Inc)
Estimated Project Budget. The following budget is presented to Sponsor in Australian Dollars (A$): Services Unit # Units Unit Cost Fees Estimated Estimated Services Unit Units (A$) Fees (A$) Estimated Pass-Thru (A$) Estimated Total Cost (A$) CLINICAL DATA MANAGEMENT • Clinical Data Project Management Oversight - Project Director — Int’l (CDM Manager assumes US Days **** *% FTE*** **** **** **** Sub Total Project Management **** **** **** PEP005-001 (Actinic Keratoses) - Clinical Writing—Clinical Study Report > Senior Clinical Writer ° First Draft (Writing and QC) Days **** **** **** **** **** • Lead CDA — Int’l ° Second Draft (assumes ****% FTE for **** monthsWriting and QC) Days **** **** **** **** **** • Development of Data Management Plan ° Final CSR (includes **** major Writing and **** minor revision; add’l revisions, will be billed at per diem ratesQC) Days **** **** **** **** **** • Database Development, Testing and Maintenance (assumes **** page CRF, ****) unique CRF-pages Project **** **** **** **** **** • Estimated Data Entry (actual will be bi1led) Pages **** **** **** **** **** • Estimated Data Review and Query Resolution (assumes **** issue per **** CRF pages, **** manual checks and the application of **** study assumption for **** CRF pages); assumes **** CRF pages per enrolled patient, **** pages per screen failure patient, and **** pages per drop out patient. Queries will be billed on actuals. Page **** **** **** **** **** • Quality Control Check of Database versus CRF (assumes **** CRF pages per patient) Patient > Director – Clinical Writing Days **** **** **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 24b-2 of the Securities Exchange Act of 19331934, as amended. Services Unit # Units Unit Cost Fees Estimated Estimated Services Unit Units (A$) Fees (A$) Estimated Pass-Thru (A$) Estimated Total Cost (A$) CLINICAL DATA MANAGEMENT Compilation of Clinical Study Report Appendices (continued) • Quality Control Check of Database versus CRF critical variables Patient **** **** **** **** **** • Edit Development (actuals will be billed) Edits **** **** **** **** **** • CRF and Query Tracking (includes all ancillary pageselectronic copy only; actuals will be billed) Page **** **** **** **** **** • Dictionary Coding of Adverse Event terms to MedDRA (estimated to be **** per patient; actuals will be billed) Term **** **** **** **** **** • Dictionary Coding of Medication Terms (estimated to be **** per patient; actuals will be billed) Term **** **** **** **** **** • External Vendor — Initial Load (actuals will be billed) **** >Initial Load Load **** **** **** **** **** >Subsequent Load (actuals will be billed) Monthly **** **** **** **** **** >Lab Visit Verification (**** visits x 60 patients; actuals will be billed) Visits **** **** **** **** **** • Reconciliation of the safety > Set up and Clinical Database (assumes ****% SAEs; actuals will be billed) SAE **** **** **** **** Subtotal – Clinical Data Management **** **** **** BIOMETRICS • Biometrics Team Manager Days **** **** **** **** **** • Project Data Setup management Project **** **** **** **** **** • Statistical Plan > Set up of headers & footers Project **** **** **** **** **** • Design of Table Shells (Mocks) Project **** **** **** **** **** • Programming/QC of Data Displays (actuals will be billed) Unique Tables Table **** **** **** **** **** Repeat Tables Table **** **** **** **** **** Unique Listings Listing **** **** **** **** **** Repeat Listings Listing **** **** **** **** **** Unique Figures Figure **** **** **** **** **** Repeat Figures Figure **** **** **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted > Scanned and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. # UnitCost Fees Estimated Estimated Services Unit Units (A$) (A$) Pass-Thru (A$) Total Cost (A$) BIOMETRICS (continued) • Programmatic Evaluability/Outcome Project **** **** **** **** **** • Statistical Analysis Project **** **** **** **** **** • FDA Item 11 (if required) Project **** **** **** **** **** • Standard Data Transfer > Initial Transfer Cleaned Pages Pages **** **** **** **** **** > Subsequent Transfer Hyperlinks Links **** **** **** **** **** Add’l Stats consulting, meeting attendance, etc., will be charged at per diem rates as follows: Team Leader Days **** Statistician Days **** Programmer Days **** Subtotal — Biometrics **** **** **** CLINICAL WRITING • Clinical Study Report Phase 11 (Report includes **** major (up to **** days) and **** minor (up to **** day) revision; does not include compilation of Clinical Study Report Appendices; per Omnicare SOPs) Report > Volumes Volumes **** **** **** **** **** • Narratives (actuals will be billed) Narrative > Headers & Footers Volumes **** **** **** **** **** • Clinical Writing Input to SAP Project Sub Total PEP005-001 **** **** **** **** **** • Sponsor Meeting Attendance PEP005-004 (billed on actuals; Actinic Keratoses) Clinical Writing – Clinical Study Report > Senior Clinical Writer International° First Draft (Writing and QC) Days **** **** **** **** **** Attendance at Sponsor Requested Meetings: Attendances Sponsor requested meetings ° Second Draft (teleconferences/video conferences or client review/planning meeting at Sponsor/Omnicare CR, Inc.Writing and QC) will be billed to Sponsor according to the following per diem rates: Director Days **** Senior Writer Days **** Clinical Writer Days **** Sponsor will be billed for actual time expended. Subtotal — Clinical Writing **** **** **** MISCELLANEOUS • Return **** **** ° Final CSR (Writing and QC) Days **** **** **** **** **** > Director – Clinical Writing Days **** **** **** **** **** - Compilation of CRF Clinical Study Report Appendices (hard copy)electronic copy only; bxxx on actuals will be billed) > Set up and management Project **** **** **** **** **** > Set up of headers & footers Project **** **** **** **** **** > Scanned and Cleaned Pages Pages **** **** **** **** **** Subtotal - Miscellaneous > Hyperlinks Links **** **** **** **** **** > Volumes Volumes **** **** **** **** **** > Headers & Footers Volumes **** **** **** **** **** Sub Total PEP005-004 **** **** **** Estimated Services Budget **** Estimated Pass Through **** Total Estimated Budget **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Appears in 1 contract
Samples: Change (Peplin Inc)
