Clinical Study Report. The integrated clinical and statistical summary will be prepared in accordance with ICH guidelines on the “Structure and Content of Clinical Study Reports”, appropriate agency regulations, and Omnicare CR’s SOI’s 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 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 ****. The second draft will be reviewed within the Clinical Writing Department at Omnicare CR 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 finalised. Omnicare CR Biometrics will provide up to **** tables, **** listings and **** figures that will be summarised in the clinical study report. **** 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. This fee includes **** major and **** minor revision. One major revision of the draft report is considered to be up to **** (****) days of requested changes and a minor revision is up to **** (****) day of requested changes. Patient narratives will be drafted from final patient data listings. Omnicare CR Clinical Writing will prepare patient narratives for SAEs and discontinuations due to adverse events based upon a $**** per narrative fee. This fee does not include the collation or compilation of clinical study report appendices. Omnicare CR Clinical Writing will review the draft statistical analysis plan and mock summary tables and data listings for consistency with the protocol and ICH guidelines. Clinical Wri...
Clinical Study Report. Protagonist shall use Diligent Efforts to complete the clinical study report for the Phase 1 Clinical Trial of the Initial Product set forth in the Clinical Development Plan as promptly as is practicable following the delivery of the Phase 1 Data Package, and shall deliver such clinical study report to Xxxxxxx promptly following its completion (and, in any event, no later than [ * ] after the Phase 1 Completion Date). [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended.
Clinical Study Report. Xxxxxxx shall use Diligent Efforts to complete the clinical study report for the CD Phase 2 Clinical Trial as promptly as is practicable following the delivery of the Phase 2 Data Package, and shall deliver such clinical study report to Protagonist promptly following its completion.
Clinical Study Report. 7.1. If the Study is considered as successful by AIM ImmunoTech and AstraZeneca, a full manuscript could be drafted by Erasmus MC.
Clinical Study Report. A Phase II, 24-Week, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study to Examine Safety, Tolerability and Efficacy of Topiramate and Phentermine Combination Therapy for Weight Loss in Healthy Obese Subjects. Data on file. VIVUS, Inc., Mountain View, CA.
Clinical Study Report. As of the First Amendment Effective Date, Protagonist has delivered to Xxxxxxx the clinical study report and Phase 1 Data Package for the Phase 1 Clinical Trial of the Initial Product set forth in the Clinical Development Plan. Protagonist shall use Diligent Efforts to complete the clinical study report for the Phase 1 Clinical Trial of the first 2nd Generation Product set forth in the 2nd Generation Development Plan as promptly as is practicable following the delivery of the Phase 1 Data Package therefor, and shall deliver such clinical study report to Xxxxxxx promptly following its completion (and, in any event, no later than [*] after the Phase 1 Completion Date for such 2nd Generation Product).
Section 3.4.1 is amended by replacing it in its entirety with the following:
Clinical Study Report. The Aptiv Solutions Medical Writer will be responsible for writing the study report based on an Aptiv Solutions report template and the statistical output. In addition, the Medical Writer can provide guidance with the protocol, ICF/IB, and statistical analysis plan as requested. The Clinical Study Report will be written following ICH guidelines. Aptiv Solutions will prepare a Clinical/Statistical Report that consists of a summary of the clinical study with emphasis on clinical and statistical interpretations of the study. The report will describe the rationale of the study, the study plan and design and the statistical methodology. The report will be structured according to document specifications and the word processing format requested by Actinium. A QC review will be performed to check the accuracy of the number transfer from the analysis tables and figures to the report. Preparation of the report also includes a Key Messages Meeting, which can be done via teleconference as needed. The purpose of this meeting is to discuss the results of the study in context of the objectives and endpoints stated in the protocol. This meeting also gives Actinium the opportunity to provide the "key messages" that should be developed in the report. Participants in the Key Messages Meeting include the Medical Writer and Actinium; the Medical Monitor/Advisor, and the PM. Other persons may participate as needed. The report review process includes
Clinical Study Report. The Parties acknowledge that COMPANY will and GCAR may prepare a Clinical Study Report for the COMPANY Arm. A Party preparing a Clinical Study Report for the COMPANY Arm shall provide the other Party with a draft of such Clinical Study Report and such other Party shall have the right to review and comment on such draft; the drafting Party shall give due consideration to the other Party’s comments. The Parties will cooperate in good faith to address any reasonable comments prior to finalization of the Clinical Study Report. Once finalized, the drafting Party shall send the other Party the finalized Clinical Study Report.
Clinical Study Report. The costs for the Clinical Study Report (CSR) for the AN01.01.0011 study are based on the following assumptions, with any deviations from these assumptions requiring a further recost: · Amarin want the existing CSR for the double-blind phase (dated 01 June 2007) to be updated to include the OLE study methods and results, a brief summary of the EFA laboratory data (maximum one days work), and a revision of the double-blind data. It has been assumed that any changes to the double-blind data will not change the message of the existing CSR dated 01 June 2007. · The cost includes the provision of a mock report including shell results tables for client review. · Two sets of consolidated client comments after the provision of Draft 1. Any additional revisions will be charged on a timesheet basis. · ICON has provided a separate unit cost for narrative writing and updates as required. · ICON Medical Writing will not be compiling the appendices. The costs for this are £25,844 The costs for the open-label extension CSR addendum for the AN.01.01.0012 study will be charged on a timesheet basis using the hourly rates in section 3 below. It is estimated that the cost will be £23,802, which includes revisions based on two sets of consolidated client comments, but excludes an estimate for narratives (for which unit costs are presented below). Protocol AN01.01.0012 & AN01.01.0011 28th May 2008 Various different complexities of work will need to be done to the patient narratives for both studies. These will be charges on a unit basis as detailed below: · A new narrative written from scratch -* £204.05 per narrative · An existing narrative QC'd against listings and SAE reports/CIOMS, and updated à £153.04 · An existing narrative QC'd against listings only, and updated à £102.02 (Exchange rate used = €1 =£0.6988, as per contract) Protocol AN01.01.0012 & AN01.01.0011 28th May 2008
Clinical Study Report. Xx. Xxxxx Xxxxxxxxx, Università degli Studi di Milano, Italy, will write the data analysis, clinical study report, and publication draft.
