Clinical Research Organization definition

Clinical Research Organization or “CRO” means independent organization that provides outsourced pharmaceutical research services or Clinical Trial for drugs.
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Clinical Research Organization means a company or organization contracted by a sponsor to assume various aspects of the human research project.
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Clinical Research Organization means any entity to whom a sponsor may transfer or delegate one or more of its functions and duties regarding conduct of clinical investigation or clinical performance evaluation;
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Examples of Clinical Research Organization in a sentence

  • It includes Production unit, Quality Control department, Quality Assurance department, Analytical laboratory, Chemical manufacturing unit, Pharmaceutical R&D, Hospital (Clinical Pharmacy), Clinical Research Organization, Community Pharmacy, etc.

  • The Company has Clinical Research Organization supplier agreements in place for clinical research services related to the management of the Company’s clinical stage programs.

  • The Transfers of Value made indirectly via a Clinical Research Organization (CRO) are also included in the R&D section of the disclosure report.

  • HCRN will serve as the Clinical Research Organization for this trial.

  • If the sponsor of the project does not have a Clinical Research Organization (CRO) to perform monitoring, Harvard will issue a RFP for these services.

  • Laboratory tests conducted on our behalf by an independent Clinical Research Organization, or CRO, using the “one-pot” method demonstrated that our Impede Technology disrupted the direct conversion of PSE from the tablets into methamphetamine.

  • The review has apparently not led to boundary changes for Crowthorne ward although has led to an increase from 2 to 3 for borough ward Councillors from 2023.

  • Since they satisfying all the conditions as specified in Notification No. 12/2017-CT (Rate) dated 28.06.2017, hence services provided to the Clinical Research Organization (Inforetell) should be exempt.

  • For CarnaLife Holo, it plans to file the application in H2/22E, whereby it is supported by the well-known and experienced US-based Clinical Research Organization (CRO) Parexel International.

  • DEINOVE chose Medpace (NASDAQ: MEPD) as the Clinical Research Organization (CRO) to oversee the clinical trial expected to begin mid-2019.


More Definitions of Clinical Research Organization

Clinical Research Organization has the meaning set forth in Section 3.9(h).
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Clinical Research Organization means a scientific organization to which a sponsor may transfer in writing some of its duties and functions;
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Clinical Research Organization or “CRO” means a person or an organization contracted by AstraZeneca to perform one or more of AstraZeneca’s study-related duties and functions. The CRO for a Study, if applicable, will be provided in each respective Clinical Study Addendum.
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Clinical Research Organization means Third Party organizations contracted by Wyeth-Ayerst to manage the Clinical Studies hereunder.
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Related to Clinical Research Organization

  • Public research university means Rutgers, The State University

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • 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;

  • clinical evidence means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

  • industrial research means the planned research or critical investigation aimed at the acquisition of new knowledge and skills for developing new products, processes or services or for bringing about a significant improvement in existing products, processes or services. It comprises the creation of components parts of complex systems, and may include the construction of prototypes in a laboratory environment or in an environment with simulated interfaces to existing systems as well as of pilot lines, when necessary for the industrial research and notably for generic technology validation;

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • scientific research means any activity in the field of natural or applied science for the extension of knowledge;

  • Analytical x-ray system means a group of components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

  • Public university means a public university described in section 4, 5, or 6 of article VIII of the state constitution of 1963.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Pivotal Clinical Trial means a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • Medical evaluation means the process of assessing an individual's health status that includes a medical history and a physical examination of an individual conducted by a licensed medical practitioner operating within the scope of his license.

  • Research and development facility means an establishment engaged in laboratory, scientific, or experimental testing and development related to new products, new uses for existing products, or improving existing products. The term does not include an establishment engaged in efficiency surveys, management studies, consumer surveys, economic surveys, advertising, promotion, banking, or research in connection with literary, historical, or similar projects.

  • Clinical record means a legible electronic or hard-copy history that documents the criteria established for medical records as set forth in rule 441—79.3(249A). A claim form or billing statement does not constitute a clinical record.

  • Research Use shall have the meaning given in Section 2.2.2 of this Agreement.

  • Civil Aeronautical Product means any civil aircraft, aircraft engine, or propeller or subassembly, appliance, material, part, or component to be installed thereon.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Research record means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.