Common use of Clinical Study Report — Phase Clause in Contracts

Clinical Study Report — Phase. III It will be the responsibility of the assigned Director Clinical Writing to ensure delivery of integrated statistical and clinical study report for this Project. The integrated clinical and statistical summary will be prepared in accordance with ICH-GCP Guidelines on the “Structure and Content of Clinical Study Reports” appropriate agency regulations, and Omnicare’s SOPs and clinical study report format. A draft clinical report will be generated within **** (****) weeks after receipt of source material and final summary tables and patient data listings. The designated Omnicare CR clinical writers will liaise closely with the statistician and other Project Team members. All clinical documents will receive two levels of quality control reviews before they are released. There will be a QC review by an independent 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. The second draft clinical study report will be produced after receipt of one set of collated comments from the Sponsor. It is our experience at Omnicare CR that this can be facilitated, more speedily, by **** **** 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. ****. The second draft will be reviewed within the Clinical Writing Department at Omnicare to ensure that all Sponsor comments are addressed and that all changes are consistent with the supporting data. Following the Sponsor’s second review, minor revisions will be made and the report finalized. The fee for this report includes the drafting of the methodology sections in advance of the results section of the study report, as requested by the Sponsor. The methods section will contain the full methodology and planned analyses details (ICH-GCP Guidelines Sections 1-9). The methods sections will be drafted after receipt of the final statistical analysis plan. An internal clinical writing review for consistency with the ICH-GCP Guidelines and for accuracy with the source documentation will be completed. The draft methodology section will be provided to the Sponsor. The writing fee estimates are based on receipt of final data. If database Changes occur which require a substantial amount of time (>l/2 day overall) for rework or repeat quality control, additional fees will be agreed upon with Sponsor before proceeding.

Clinical Study Report — Phase. III It will be the responsibility of the assigned Director Clinical Writing to ensure delivery of integrated statistical and clinical study report for this Project. The integrated clinical and statistical summary will be prepared in accordance with ICH-GCP Guidelines on the “Structure and Content of Clinical Study Reports” appropriate agency regulations, and Omnicare’s SOPs and clinical study report format. A draft clinical report will be generated within **** (****) weeks after receipt of source material and final summary tables and patient data listings. The designated Omnicare CR clinical writers will liaise closely with the statistician and other Project Team members. All clinical documents will receive two levels of quality control reviews before they are released. There will be a QC review by an independent 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. The second draft clinical study report will be produced after receipt of one set of collated comments from the Sponsor. It is our experience at Omnicare CR that this can be facilitated, more speedily, by **** **** 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. ****. The second draft will be reviewed within the Clinical Writing Department at Omnicare to ensure that all Sponsor comments are addressed and that all changes are consistent with the supporting data. Following the Sponsor’s second review, minor revisions will be made and the report finalized. The fee for this report includes the drafting of the methodology sections in advance of the results section of the study report, as requested by the Sponsor. The methods section will contain the full methodology and planned analyses details (ICH-GCP Guidelines Sections 1-9). The methods sections will be drafted after receipt of the final statistical analysis plan. An internal clinical writing review for consistency with the ICH-GCP Guidelines and for accuracy with the source documentation will be completed. The draft methodology section will be provided to the Sponsor. The writing fee estimates are based on receipt of final data. If database Changes occur which require a substantial amount of time (>l/2 > 1/2 day overall) for rework or repeat quality control, additional fees will be agreed upon with Sponsor before proceeding.

Clinical Study Report — Phase. III It will be the responsibility of the assigned Director Clinical Writing to ensure delivery of integrated statistical and clinical study report for this Project. The integrated clinical and statistical summary will be prepared in accordance with ICH-GCP Guidelines on the “Structure and Content of Clinical Study Reports” appropriate agency regulations, and Omnicare’s SOPs and clinical study report format. A draft clinical report will be generated within **** (****) weeks after receipt of source material and final summary tables and patient data listings. The designated Omnicare CR clinical writers will liaise closely with the statistician and other Project Team members. All clinical documents will receive two levels of quality control reviews before they are released. There will be a QC review by an independent 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. The second draft clinical study report will be produced after receipt of one set of collated comments from the Sponsor. It is our experience at Omnicare CR that this can be facilitated, more speedily, by **** **** 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. ****. The second draft will be reviewed within the Clinical Writing Department at Omnicare to ensure that all Sponsor comments are addressed and that all changes are consistent with the supporting data. Following the Sponsor’s second review, minor revisions will be made and the report finalized. The fee for this report includes the drafting of the methodology sections in advance of the results section of the study report, as requested by the Sponsor. The methods section will contain the full methodology and planned analyses details (ICH-GCP Guidelines Sections 1-9). The methods sections will be drafted after receipt of the final statistical analysis plan. An internal clinical writing review for consistency with the ICH-GCP Guidelines and for accuracy with the source documentation will be completed. The draft methodology section will be provided to the Sponsor. The writing fee estimates are based on receipt of final data. If database Changes occur which require a substantial amount of time (>l/2 day overall) for rework or repeat quality control, additional fees will be agreed upon with Sponsor before proceeding.

Clinical Study Report — Phase. III It will be the responsibility of the assigned Director Clinical Writing to ensure delivery of integrated statistical and clinical study report for this Project. The integrated clinical and statistical summary will be prepared in accordance with ICH-GCP Guidelines on the “Structure and Content of Clinical Study Reports” appropriate agency regulations, and Omnicare’s SOPs and clinical study report format. A draft clinical report will be generated within **** (****) weeks after receipt of source material and final summary tables and patient data listings. The designated Omnicare CR clinical writers will liaise closely with the statistician and other Project Team members. All clinical documents will receive two levels of quality control reviews before they are released. There will be a QC review by an independent 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. The second draft clinical study report will be produced after receipt of one set of collated comments from the Sponsor. It is our experience at Omnicare CR that this can be facilitated, more speedily, by **** **** 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. ****. The second draft will be reviewed within the Clinical Writing Department at Omnicare to ensure that all Sponsor comments are addressed and that all changes are consistent with the supporting data. Following the Sponsor’s second review, minor revisions will be made and the report finalized. The fee for this report includes the drafting of the methodology sections in advance of the results section of the study report, as requested by the Sponsor. The methods section will contain the full methodology and planned analyses details (ICH-GCP Guidelines Sections 1-9). The methods sections will be drafted after receipt of the final statistical analysis plan. An internal clinical writing review for consistency with the ICH-GCP Guidelines and for accuracy with the source documentation will be completed. The draft methodology section will be provided to the Sponsor. The writing fee estimates are based on receipt of final data. If database Changes occur which require a substantial amount of time (>l/2 > 1/2 day overall) for rework or repeat quality control, additional fees will be agreed upon with Sponsor before proceeding.