Contract Research Organization definition

Contract Research Organization means an entity in the business of providing specialized research, development and manufacturing services (including CMOs) on a fee for service basis pursuant to agreements that include terms that provide that all data, materials and intellectual property generated in performing such services be owned by the contracting party in accordance with Section 3.1(i), excluding Improvements to such entity’s Technology that is used to perform such services.
Contract Research Organization means a person or an organization contracted by the Sponsor to perform one or more of a Sponsor trial-related duties and functions;
Contract Research Organization means an organization that provides research, support, or manufacturing services to the pharmaceutical and/or biotechnology industries, provided that such organization has entered into a written agreement with Licensee in which the organization: (a) is granted no right to Sell or distribute Products; (b) does not make a payment, or otherwise provide consideration, to Licensee for the rights granted in such agreement; and (c) has agreed to be bound by all of Licensee’s duties and obligations (or substantially similar duties and obligations) under this Agreement (excluding payment obligations under Article IV hereof) relating to the use and protection of Licensed Subject Matter and MD Anderson’s Confidential Information.

Examples of Contract Research Organization in a sentence

  • If the Grantee has participating persons, facilities or elements at any Contract Research Organization (CRO) or has participating persons, facilities or elements at any research institution such as a university (‘Participating Institution’) outside the Sponsoring Institution, it is the responsibility of the Sponsoring Institution to subcontract with (those) CRO(s) or Participating Institution(s) on the same terms agreed to in this Agreement with LLS.

  • Venn Life Sciences AG has been contracted by Bioline Innovations Jerusalem to provide services as the Contract Research Organization (CRO) for the trial.

  • All task orders under Master Contract Research Organization Agreement, effective November 1, 2011, as amended to date, by and between Westat Inc.

  • Master Contract Research Organization Agreement, effective November 1, 2011, as amended to date, by and between Westat Inc.

  • In case a Contract Research Organization (CRO) is signing this agreement on behalf of the Sponsor or in its own name, please note that depending on the Power of Attorney / Delegation of Authority given by sponsor to the CRO, a separate indemnity letter signed by Sponsor may be needed.

  • The Company acknowledges that the Consultant is not a "Contract Research Organization" or "Sponsor" as defined in Title 2.1 of the U.S. Code of Federal regulations, and the Company shall retain full responsibility for the content of certain documents and regulatory submission, for interpretation of the data contained therein and for the timing, preparation and processing of regulatory submissions.

  • In addition, each Party may subcontract its activities to be performed under the Workplan to a Contract Research Organization.

  • Fax: +▇▇ ▇▇ ▇▇▇ ▇▇▇▇ Email: [*] Contract Research Organization (CRO): Nordic Bioscience A/S ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇ Tel: +▇▇ ▇▇▇▇ ▇▇▇▇.

  • CRO - Contract Research Organization FPI - First Patient In JDC - Joint Development Committee LPO - Last Patient Out MRD - Multiple Rising Dose OLE - Open label extension SRD - Single Rising Dose THE - Cortisol: tetrahydrocortisone THF - tetrahydrocortisol ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

  • Management of the clinical development program and requisite regulatory support will be performed by TRI (Technical Resources International), a highly experienced Contract Research Organization with experience supporting ~800 vaccine studies, extensive knowledge of clinical trial management and regulatory relative to vaccine development and registration.


More Definitions of Contract Research Organization

Contract Research Organization means a reputable Third Party research or development organization one of whose principal businesses is the provision of contract research or development services to unrelated Persons.
Contract Research Organization or “CRO” means any Third Party contract research organization.
Contract Research Organization or “CRO” means an entity or organization that provides research and development services commonly outsourced on a contracted fee-for-service basis.
Contract Research Organization means a Third Party with which a Party has contracted to conduct, organize, monitor, and/or oversee Clinical Trials of one or more Products on behalf of such Party, other than a bona fide collaborator of such Party (e.g., a Third Party with whom such Party can jointly develop any other product).
Contract Research Organization or “CRO” means person or organization contracted by the sponsor, for purpose to perform one or more of its trial related activities and functions;
Contract Research Organization. (CRO) means an entity that assumes, as an independent contractor with Company one or more of the obligations of a the Company hereunder, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration. For purposes of this Agreement and the Clinical Trial, Company has engaged […***…], d/b/a […***…] as CRO. References herein to “Company” shall be deemed to include CRO as the context requires. “Data and Safety Monitoring Board (or Committee)” (DSMB or DSMC) is an independent group of experts that advises the Company and the Investigators. The primary responsibilities of the DSMB are to: (i) to periodically review and evaluate the accumulated data of the Clinical Trial for participant safety, Clinical Trial conduct and progress, and when appropriate, efficacy; and (ii) to make recommendations to the Company concerning the continuation, modification, or termination of the Clinical Trial.

Related to Contract Research Organization

  • Procurement organization means an eye bank, organ procurement organization, or tissue bank.

  • Nonprofit organization means an organization that is exempt from federal income taxation pursuant to Section 501(a) of the Code and described in Section 501(c) of the Code and that has as one of its designated activities, as indicated on United States Internal Revenue Service form 1023 "recognition of exemption", an activity that is directly related to the purposes for which grants may be issued under Revised Code Sections 164.20 through 164.27 as described in divisions (A) and (B) of Revised Code Section 164.22

  • research organisation means a legal entity established as a non-profit organisation which carries out research or technological development as one of its main objectives;

  • Quality improvement organization or “QIO” shall mean the organization that performs medical peer review of Medicaid claims, including review of validity of hospital diagnosis and procedure coding information; completeness, adequacy and quality of care; appropriateness of admission, discharge and transfer; and appropriateness of prospective payment outlier cases. These activities undertaken by the QIO may be included in a contractual relationship with the Iowa Medicaid enterprise.

  • Student organization means a group, club or organization having students as its primary members or participants. It includes grade levels, classes, teams, activities or particular school events. A student organization does not have to be an official school organization to come within the terms of this definition.