Estimated Project Budget. Unit Estimated Estimated # Cost Pass-Thru Total Cost Services Unit Units (A$) Fees (A$) (A$) (A$) CLINICAL DATA MANAGEMENT • Clinical Data Management Oversight — Int’l (CDM Manager assumes ****% FTE 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 **** months 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 will be billed at per diem rates) Days **** **** **** **** **** • Database Development, Testing and Maintenance (assumes **** page CRF, **** unique CRF pages) Project **** **** **** **** **** • Estimated Data Entry (actuals will be billed) 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. Based on number of CRF Pages, actuals will be billed Page **** **** **** **** **** • Quality Control Check of Database versus CRF (assumes **** CRF pages per patient) Patient **** **** **** **** **** • 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) — Initial Load (actuals will be billed) **** Initial Load Load **** **** **** **** **** >Subsequent Load (actuals will be billed) Monthly **** **** **** **** **** Lab Visit Verification (**** visits x 60 patient’s: 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 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 **** **** **** **** **** • 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 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 **** **** **** **** **** **** 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: Sponsor will be billed for actual time expended. Attendance at Sponsor requested meetings (teleconferences/video conferences or client review/planning meetings at Sponsor/Omnicare CR) will be billed to Sponsor according to the following per diem rates: Director **** Senior Writer Days **** Clinical Writer Days **** Subtotal — Clinical Writing **** **** **** MISCELLANEOUS • Return of CRF (hard copy); bxxx on actuals Pages **** **** **** **** **** Subtotal — Miscellaneous **** **** **** Estimated Services Budget **** Estimated Pass Through **** Total Estimated Budget ****
Appears in 1 contract
Samples: Change (Peplin Inc)
Estimated Project Budget. Unit # Cost Fees Estimated Estimated # Cost 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 ****% FTE x **** month for Start-up, ****% FTE for **** months for Duration, and ****% FTE for **** months for Close-outFTE) Days **** **** **** **** **** • Lead CDA — Int’l (assumes ****% FTE x **** month for Start-up, ****% FTE for **** months for Duration and ****% FTE for **** months for Close-outmonths) —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) CRF-pages Project **** **** **** **** **** • Estimated Data Entry (actuals actual will be billedbi1led) 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. Based on number of CRF Pages, actuals 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 (**** 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 patient’s: patients; 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 II; 11 (Report 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: Sponsor will be billed for actual time expended. Attendance at Attendances Sponsor requested meetings (teleconferences/video conferences or client review/planning meetings 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 Pass-Thru Total Cost cost Services Unit Units (A$) Fees (A$) (A$) (A$) CLINICAL DATA AUD AUD AUD AUD STUDY MANAGEMENT • Project Leader / Clinical Data Management Oversight Trial Manager — Int’l Australia (CDM Manager assumes ****% FTE x **** days per month for Start-up, ****% FTE for **** months for Duration, and ****% FTE for **** months for Close-outmonths) Days **** **** **** **** **** • Lead CDA Int’l (assumes ****% FTE x **** month for Start-up, ****% FTE for **** months for Duration and ****% FTE for **** months for Close-out) Project Administrative Support/Coordination —Actual days will be billed Days **** **** **** **** **** • Development of Data Management Plan Australia (includes **** major and **** minor revision; add’l revisions will be billed at per diem ratessupport for all functional areas) Days **** **** **** **** **** • Database Development, Testing and Maintenance (assumes Subtotal — Study Management **** page CRF, **** unique CRF pages**** CLINICAL TRIAL INITIATION • Study Master File (America; **** site for **** months) Project Site Months **** **** **** **** **** • Estimated Data Entry Regulatory Document Collection (actuals 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) Pages 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 cost Services Unit Units AUD AUD AUD AUD >Site Initiation Visit (A$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 (A$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 (A$actuals months will be billed) Months **** **** **** **** **** • Global Safety Coordinator in the US (A$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 — Americas (continuedassumes ****% FTE x **** months Startup, ****% FTE x **** months, and ****% FTE x **** months Close-out) Days **** **** **** **** **** • Development of Data Management Plan (includes **** major and **** minor revision; 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) Project **** **** **** **** **** • Estimated Data Entry (actuals will be billed) — 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. Based on number of CRF Pages, actuals Queries will be billed Page on actuals (Based on issues) Issue **** **** **** **** **** • Quality Control Check of Database versus CRF (assumes **** CRF pages per patient) Patient **** **** **** **** **** • Quality Control Check of Database versus CRF critical variables (**** minutes/patient) Patient Page **** **** **** **** **** • Edit Development (actuals will 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 **** **** **** **** **** • Dictionary Coding of Medication Terms Medical History (estimated to be **** per patient; actuals will be billed) Term **** **** **** **** **** • External Vendor) — PK Laboratory Data >Initial Load (actuals will be billed) **** Initial Load Load **** Project **** **** **** **** >Subsequent Load Loading (actuals will be billed) Monthly Load **** **** **** **** **** >Lab Header Visit Verification (**** visits x 60 patient’s: **** 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 # Cost Fees Pass-Thru Total Cost cost Services Unit Units (A$) Fees (A$) (A$) (A$) AUD AUD AUD AUD BIOMETRICS ANALYSIS • Biometrics Team Manager (includes Project Management) 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 **** **** **** **** **** • Programmatic Evaluability/Outcome Project **** **** **** **** **** • Statistical Analysis Project **** **** **** **** **** • Statistical Report (Top Line Stats Summary ReportReg.) Project **** **** **** **** **** • FDA Item 11 Statistical Report (if requiredRegular) 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 II; > 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 CR SOPs) CSR appendices Report **** **** **** **** **** • Narratives Narrative (actuals will be billed) Narrative **** **** **** **** **** • Clinical Writing Input to SAP Project **** **** **** **** **** • Sponsor Meeting Attendance (Senior Writer; actuals will be billed) Days **** **** **** **** **** Attendance at Sponsor Requested Meetings: Attendance at Sponsor requested meetings (teleconferences/video conferences or Sponsor review/planning meetings at Sponsor/Omnicare CR, Inc.) will be billed to Sponsor according to the following per diem rates: Director: **** Senior Writer: **** Clinical Writer: **** Sponsor will be billed for actual time expended Subtotal — Clinical Writing **** **** **** 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 cost Services Unit Units AUD AUD AUD AUD • CRF Filing and Reconciliation (A$bxxx on actuals) Fees (A$) (A$) (A$) CLINICAL WRITING (continued) Attendance at Sponsor Requested Meetings: Sponsor will be billed for actual time expended. Attendance at Sponsor requested meetings (teleconferences/video conferences or client review/planning meetings at Sponsor/Omnicare CR) will be billed to Sponsor according to the following per diem rates: Director **** Senior Writer Days **** Clinical Writer Days **** Subtotal — Clinical Writing Pages **** **** **** MISCELLANEOUS **** **** • Return of CRF (hard copy); bxxx on actuals Pages **** **** **** **** **** Subtotal — Miscellaneous • 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 Pass-Thru Total Cost The following budget is presented to Sponsor in Australian Dollars (A$): Services Unit # Units Unit Cost (A$) Fees (A$) Estimated Pass-Thru (A$) Estimated Total Cost (A$) CLINICAL DATA MANAGEMENT • Clinical Data Project Management Oversight - Project Director — Int’l (CDM Manager assumes ****% FTE x US Days **** month for Start-up, ****% FTE for **** months for Duration, and ****% FTE for **** months for Close**** **** Sub Total Project Management **** **** **** PEP005-out001 (Actinic Keratoses) - Clinical Writing—Clinical Study Report > Senior Clinical Writer ° First Draft (Writing and QC) Days **** **** **** **** **** • Lead CDA Int’l ° Second Draft (assumes ****% FTE x **** month for Start-up, ****% FTE for **** months for Duration Writing and ****% FTE for **** months for Close-out) —Actual days will be billed Days **** **** **** **** **** • Development of Data Management Plan (includes **** major and **** minor revision; add’l revisions will be billed at per diem ratesQC) Days **** **** **** **** **** • Database Development, Testing ° Final CSR (Writing and Maintenance (assumes **** page CRF, **** unique CRF pagesQC) Project Days **** **** **** **** **** • Estimated Data Entry (actuals will be billed) Pages > Director – Clinical Writing Days **** **** **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 24b-2 of the Securities Exchange Act of 19331934, as amended. Unit Estimated Estimated # Cost Pass-Thru Total Cost Services Unit # Units Unit Cost (A$) Fees (A$) Estimated Pass-Thru (A$) Estimated Total Cost (A$) CLINICAL DATA MANAGEMENT Compilation of Clinical Study Report Appendices (continued) • Estimated Data Review and Query Resolution (assumes **** issue per **** CRF pages, **** manual checks and the application of **** study assumption for **** CRF pages)electronic copy only; assumes **** CRF pages per enrolled patient, **** pages per screen failure patient, and **** pages per drop out patient. Based on number of CRF Pages, actuals will be billed Page billed) > Set up and management Project **** **** **** **** **** • Quality Control Check > Set up of Database versus CRF (assumes **** CRF pages per patient) Patient headers & footers Project **** **** **** **** **** • Quality Control Check of Database versus CRF critical variables (**** minutes/patient) Patient > Scanned and Cleaned Pages Pages **** **** **** **** **** • Edit Development (actuals will be billed) Edits > Hyperlinks Links **** **** **** **** **** • CRF and Query Tracking (includes all ancillary pages; actuals will be billed) Page > Volumes Volumes **** **** **** **** **** • Dictionary Coding of Adverse Event terms to MedDRA (estimated to be **** per patient; actuals will be billed) Term > Headers & Footers Volumes **** **** **** **** **** • Dictionary Coding of Medication Terms (estimated to be **** per patient; actuals will be billed) Term Sub Total PEP005-001 **** **** **** **** **** • External VendorPEP005-004 (Actinic Keratoses) — Initial Load Clinical Writing – Clinical Study Report > Senior Clinical Writer ° First Draft (actuals will be billed) **** Initial Load Load **** **** **** **** **** >Subsequent Load (actuals will be billed) Monthly **** **** **** **** **** Lab Visit Verification (**** visits x 60 patient’s: actuals will be billed) Visits **** **** **** **** **** • Reconciliation of the Safety Writing 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 Estimated Estimated # Cost Pass-Thru Total Cost Services Unit Units (A$) Fees (A$) (A$) (A$) BIOMETRICS • Biometrics Team Manager (includes Project ManagementQC) Days **** **** **** **** **** • Project Data Setup ° Second Draft (Writing and QC) Days **** **** **** **** **** ° Final CSR (Writing and QC) Days **** **** **** **** **** > Director – Clinical Writing Days **** **** **** **** **** - Compilation of Clinical Study Report Appendices (electronic copy only; actuals will be billed) > Set up and 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 **** **** **** **** **** • 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 II; includes **** major (up to **** days), > Scanned 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 **** **** **** **** **** **** 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: Sponsor will be billed for actual time expended. Attendance at Sponsor requested meetings (teleconferences/video conferences or client review/planning meetings at Sponsor/Omnicare CR) will be billed to Sponsor according to the following per diem rates: Director **** Senior Writer Days **** Clinical Writer Days **** Subtotal — Clinical Writing **** **** **** MISCELLANEOUS • Return of CRF (hard copy); bxxx on actuals 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 ****
Appears in 1 contract
Samples: Change (Peplin Inc)
