Study Management. Project Leader The Project Leader will act as a single point of contact for Sponsor during the course of the Project. The Project Leader is responsible for the generation of detailed Project timelines and ensures that these milestones are met. The Project, Leader will provide on-going Project status reports as agreed with Sponsor and will proactively identify and resolve critical Project issues. The Project Leader is also responsible fox managing the study budget and addressing all out-of-scope items with Sponsor. In addition, the Project Leader is acting in a dual role this person will also be responsible for usual Clinical Trial Manager (CTM) activities including overseeing all site and clinical research associate (CRA) activity for the project in the US. The CTM is also responsible for developing case report forms (CRF’s) and monitoring guidelines; overseeing regulatory document management for the investigational site and for reviewing and tracking the Project CRA activities which include the scheduling of site visits, site visit reports, monitoring logs and follow-up correspondence. Project Administrative Support/Coordination The Project Coordinator provides the necessary administrative support for all functional areas with administrative related tasks.
Study Management. The overall management of the study will be the responsibility of the Senior Clinical Trial Manager (CTM). The Senior CTM will oversee and coordinate the management of the study as well as oversee the study specific CTM. This oversight will ensure consistency and allow VIVUS Study Management to have one primary contact for the Qnexa program. The Medpace CTM assigned to OB-303 will work closely with the VIVUS Clinical Leader and Medpace Medical Expert to address protocol questions and interpretations while maintaining close oversight of study-related processes and documents. The OB-303 CTM will supervise all Clinical Research Associates (CRAs) and Project Coordinators assigned to the project. The Project Coordinators will be responsible for day-to-day study management functions, including the generation of status reports, organization of supplies, generation and compilation of newsletters, and input of all study information into the ClinTrak® Study Management System, a web-based, proprietary research management system designed by Medpace. The Project Coordinators will organize teleconferences and team meetings, including the compilation of agendas and meeting minutes. The Study Start-Up Manager and Study Start-Up Coordinators will work closely with the CTM and Project Coordinators to ensure sites become active in the most time effective manner. The Medpace Contracts Attorney will be responsible for the execution of Investigator contracts (upon VIVUS defined process). The Contracts Attorney will work closely with the Start-Up Manager and Medpace CTM to ensure contracts are executed in a timely manner. The Medpace Medical Expert assigned to this project will work closely with the VIVUS Clinical Leader . The Medpace Medical Expert will assist with protocol design and medical interpretation of entry criteria and adverse events (AEs). The Medical Expert will also be involved in the training of CRAs and other staff members participating in the CONFIDENTIAL September 7, 2007 *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Study Management. O Project Administrative Support/Coordination - Int’l (includes support for all functional areas - **** day per month for **** months) Days **** **** **** **** **** Sub Total Study 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. Estimated Estimated Unit Cost Pass-Thru Total Cost Services Unit # Units (A$) Fees (A$) (A$) (A$)
Study Management. 21 SECTION IX. SPECIMEN TRANSPORT..........................................22
Study Management. 1. The Quest Project Leader for any Study will interact on a regular basis with the GSK Clinical Study Leader or other designated GSK contact who shall be specified in each Task Description. Quest shall use its reasonable best efforts to retain such administrator's services for the length of each Study to which they have been assigned, in order to maintain the quality and consistency of Services. In addition, Quest shall provide a qualified back-up to such Project Leader. If such administrator's responsibilities change during the course of a Task Description, Quest shall notify the designated GSK contact of such change. Quest shall ensure that the level, quality and continuity of Services are maintained at the levels required by this Agreement despite any changes in personnel at Quest. The regional Quest Medical and Regulatory Affairs representative (or his or her designee) will use reasonable best efforts to review all concept or draft protocols at least 12 weeks prior to start of the Study (where made available by GSK) and comment on clinical testing, methodologies, sample collection/handling and sample stability. Where requested by GSK, Quest Scientific Affairs will obtain the input of Quest Diagnostics Academic Associates, Nichols Institute Scientists/Medical Directors and Nichols Xxxxitute Diagnostics personnel and use reasonabxx xxxx efforts to provide any appropriate recommendations for improvements to the GSK Clinical Study Leader within 10 working days.
Study Management. 1. The Quest Protocol Administrator for any Study will interact on a regular basis with the SB Clinical Study Leader or other designated SB contact who shall be specified in each Addendum. Quest shall use its reasonable best efforts to retain such administrator's services for the length of each Study to which they have been assigned, in order to maintain the quality and consistency of Services. In addition, Quest shall provide a qualified back-up to such Protocol Administrator. If such administrator's responsibilities change during the course of an Addendum, Quest shall notify the designated SB contact of such change. Quest shall ensure that the level, quality and continuity of Services are maintained at the levels required by this Agreement despite any changes in personnel at Quest.
Study Management. Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.
Study Management. Promotor: L’Oréal Recherche The study will be managed by L’Oréal and EOS. Time schedule April/May 2007: Clinical protocol initiation June/Nov 2007: Collection of clinical cases sections staining and reading [*] April/July 2007: Training phase for horizontal sections July/Dec 2007: Histological staining [*] Dec./Feb. 2008: Model development, Validation March 19th, 2007 CONFIDENTIAL — L’OREAL This document is the property of L’Oréal. Reproduction prohibited without written agreement of L’Oréal Certain portions of this Exhibit have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment. Such omitted portions are marked with brackets [ ] and an asterisk*. [*] Exhibit C Exhibit C L’OREAL ‘s proprietary products, technologies and methods [*] February 12th, 2007 CONFIDENTIAL — L’OREAL This document is the property of L’Oréal. Reproduction prohibited without written agreement of L’Oréal Certain portions of this Exhibit have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment. Such omitted portions are marked with brackets [ ] and an asterisk*. CONFIDENTIAL EXHIBIT D CLINICAL RESEARCH AGREEMENT This Clinical Research Agreement (this “Agreement”) is made by and between: L’OREAL, a Company organized and existing under the laws of France, having its office situated at 10 xxx Xxxxxx, 00000 Xxxxx, Xxxxxx, represented for the purpose of this Agreement by Mx. X. XXXXXXXX acting as Director of Advanced Research, Life Sciences situated 90, xxx xx Xxxxxxx Xxxxxx - 00000 Clichy cedex, France, hereinafter referred to as “L’OREAL”, AND Electro-Optical Sciences, Inc., a Delaware Corporation, 3 Xxxx Xxxx Xxxxxx, Xxxxx 000, Xxxxxxxxx Xxx Xxxx 00000, represented for the purpose of this Agreement by Jxxxxx X. Xxxxx, M.D., as Chief Executive Officer, hereinafter referred to as “EOS” L’OREAL and EOS being hereinafter referred to collectively as the “Sponsors” AND [ ], represented for the purpose of this Agreement by Rxxxx Xxxxx, M.D., acting as Investigator, hereinafter the “Institution” Sponsors and Institution being hereinafter referred to collectively as the “Parties” RECITALS: - The Sponsors have concluded a Research and Feasibility Agreement under which they have decided to sponsor jointly a clinical trial. - Consequently, the Sponsors have proposed to the Institution which has agreed to, and is equipped to, carry out a clinical study ...
Study Management. The client comprises the following organisations: • Cheshire & Warrington Local Enterprise Partnership • Cheshire East Council • Cheshire West & Xxxxxxx Council • Department for Transport Day-to-day management of the study will be carried out by a client group comprising officers of the these organisations. The Client Senior Responsible Officer is Xxxxxx Xxx, Chief Executive of the C&W LEP, and the Client Project Manager is Xxx Xxxxxx, Transport and Investment Director of the C&W LEP A working group will be established comprising officer representatives from the client organisations plus DfT, Network Rail, TfGM and Merseytravel, relevant Train Operating Companies. It is envisaged that this would meet regularly during the study. Although a considerable amount of the work is technical, we want to make sure that it is rooted in, and properly reflects, the views and aspirations of users of the railway, as well as other stakeholders, hence a wider stakeholder reference group has also been established. It is envisaged that this group will be convened three times over the course of the study: at the beginning (around mid-May) for consultants to introduce themselves to the group and identify any key issues/priorities, once during the study for any local knowledge/comment/input process, and towards the end of the study to consider the emerging conclusions. It is anticipated that the consultant would provide regular updates to the Client Group, undertake engagement with the Stakeholder Group and prepare a draft SOBC and final SOBC for comment and approval by the Cheshire and Warrington Local Transport Body prior to submission to DfT. The appointed consultant will be required to provide appropriate representation at the meetings set out above; assist with engaging key stakeholders, and producing summary meeting notes, and providing weekly progress notes. It is envisaged that most of the meetings will be via Microsoft Teams however meeting rooms will be provided by the client where face to face meetings are required.
Study Management a. Arapahoe County Representative. Arapahoe County hereby designates Xxxxx X. Xxxxxx as Arapahoe County’s representative to coordinate all communication with Columbine Valley related to the Study, including issues arising under this Agreement.
