Omnicare CR Services. Services provided by Omnicare CR and the assumptions upon which associated costs were determined are based on the Project specifications provided by Sponsor, and are outlined below. It should be noted, however, that the timeline and costs presented in this budget for these services are estimated pending review of the final specifications, protocol and case report form (CRF).
Omnicare CR Services. Services provided by Omnicare CR and the assumptions upon which associated costs were determined are based on the project specifications provided by Sponsor, and are outlined below. It should be noted, however, that the costs presented in this budget for these services are estimated pending review of the final specifications, protocol and CRF. **** 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.
Omnicare CR Services. Services provided by Omnicare CR and the assumptions upon which associated costs were determined are based on the project specifications provided by Sponsor, and are outlined below. It should be noted, however, that the costs presented in this budget for these services are estimated pending review of the final specifications, protocol and CRF.
1. Submit regulatory documents to relevant authorities ü
2. Prepare and submit Ethics Committee Applications ü
1. Protocol development (literature review, background) ü 2. Design and write protocol ü
3. Approve protocol ü
4. Print and bind protocol ü
5. Distribute protocol to sites ü
Omnicare CR Services. Services provided by Omnicare CR and the assumptions upon which associated costs were determined are based on the project specifications provided by Sponsor, and are outlined below. It should be noted, however, that the costs presented in this budget for these services are estimated pending review of the final specifications, protocol and CRF.
1. Plan Investigator’s Meeting ü
2. Prepare binders for the meeting ü
3. Present Investigator’s meeting ü
4. Attendance at meeting — Qld. — Biostatistician Only ü ü
1. Safety Plan and Master File Set Up ü
2. Document and manage all SAEs ü
3. Cover medical emergencies after hours (pager) ü
4. Develop and maintain safety database ü
5. Submit SAE reports to regulatory authorities ü
6. Prepare safety updates ü
7. Medical Monitor- Review of SAEs ü
1. Design/develop data collection system ü
2. Validate data collection system ü
3. Document control of CRFs ü
4. Enter and verify data ü
1. Design/develop data cleaning system ü 2 Validate cleaning system ü
Omnicare CR Services. Services provided by Omnicare CR and the assumptions upon which associated costs were determined are based on the project specifications provided by Sponsor, and are outlined below. It should be noted, however, that the costs presented in this budget for these services are estimated pending review of the final specifications, protocol and CRF.
1. Plan Investigator’s Meeting ü
2. Prepare binders for the meeting ü
3. Present Investigator’s meeting ü
4. Attendance at meeting — Qld. — Biostatistician Only ü ü
1. Safety Plan and Master File Set Up ü
2. Document and manage all SAEs ü
3. Cover medical emergencies after hours (pager) ü
4. Develop and maintain safety database ü 5. Submit SAE reports to regulatory authorities ü
Omnicare CR Services. Services provided by Omnicare CR and the assumptions upon which associated costs were determined are based on the project specifications provided by Sponsor, and are outlined below. It should be noted, however, that the costs presented in this budget for these services are estimated pending review of the final specifications, protocol and CRF.
A. Project Specifications B. Project Management Project Management Team SOPs Study Documents and CRF Return
C. Clinical Data Management Data Management Project Team Clinical Data Manager Lead Clinical Data Analyst (CDA) Data Management Plan Database Development Edit Specifications MedDRA Dictionary Data Management Plan Data Tracking and Data Entry Data review and Query Processing Reconciliation of Safety and Clinical Database
Omnicare CR Services. Services provided by Omnicare CR and the assumptions upon which associated costs were determined are based on the project specifications provided by Sponsor, and are outlined below. It should be noted, however, that the costs presented in this budget for these services are estimated pending review of the final documents. The assumptions used in this estimate are based on the following:
1. Sponsor holds all Project Study Master Files and must provide required documents to Omnicare CR.
2. The services to be provided have been costed to assume that the Project will be conducted according to the Project Timeline detailed in Section IV. Any changes in timeline requested by Sponsor may result in additional charges.
3. The current format of the Clinical Study Reports is in ICHE3.
4. Sponsor requires final documents to be provided to them in electronic PDF (distilled when possible) format.
5. The Senior Clinical Writer will be responsible for the revisions requested by the Sponsor in both Clinical Study Reports. A first draft report will be generated within **** (****) weeks of the provision of all documentation detailed in Section III (Point #5). All clinical documents will receive **** (****) levels of quality control reviews before they are released. There will be a QC review by an independent (second) clinical writer for accuracy and consistency, and a review by the writing manager for accuracy, client format consistency, and appropriate regulatory and clinical perspective. The first draft will then be provided to the Sponsor for review. At this time, the Sponsor and an outside consultant will review the Clinical Study Reports. The second draft Clinical Study Report will be produced after receipt of one (1) set of collated comments from the Sponsor. The second draft will be reviewed within the Clinical Writing Department to ensure that all Sponsor comments are addressed and that all changes are consistent with supporting data. Following the Sponsor’s second review, minor revisions will be made and the final finalized. An approximate timeline per Clinical Study Report is as follows: **** 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 24b-2 of the Securities Exchange Act of 1934, as amended. First Draft + **** (from provision of documentation) Review by Sponsor and Consultant + **** Second Draft + **** Review by Sponsor and...
