Clinical Outcomes Data definition

Clinical Outcomes Data means data (or the results of analysis thereof) from Clinical Trials conducted by or on behalf of Blueprint or any of its Affiliates that is useful to select patients that will benefit from the use of, to de-select patients that will not benefit from the use of, or for whom the risks of use of the Blueprint Product would outweigh the benefits from, to determine or predict disease prognosis from the use of, or to otherwise affect health outcomes associated with, in each case, the Blueprint Product or with respect to any other therapeutic product used in combination with the Blueprint Product. For clarity, all such Clinical Outcomes Data shall be Highly Sensitive Data of Blueprint.
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Clinical Outcomes Data means Data from Clinical Studies conducted by or on behalf of AZ or any of its Affiliates or under a Project Schedule with respect to a Therapeutic Product that is useful to (a) select patients that will benefit from the use of such Therapeutic Product; (b) de-select patients that will not benefit from the use of such Therapeutic Product or for whom the risks of use of such Therapeutic Product would outweigh the benefits; (c) determine or predict disease prognosis from the use of such Therapeutic Product; or (d) otherwise assess health outcomes associated with such Therapeutic Product.
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Clinical Outcomes Data means data (or the results of analysis thereof) from Clinical Trials of the Partner Product to the extent related to the safety and efficacy of such Partner Product.
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Examples of Clinical Outcomes Data in a sentence

  • Alternatives: Cost Savings and Clinical Outcomes Data in 137 patients with 2 yr.

  • What can be purchased under this RFP?All states, territories, and jurisdictions participating in the Linking PRAMS and Clinical Outcomes Data Learning Community are eligible to receive funding for a full-time equivalent (FTE) staff member or contractor in accordance with the local position market, based on state needs.

  • Clinical Outcomes Data Submissions through an approved outcomes management system.

  • All states participating in the Linking PRAMS and Clinical Outcomes Data Learning Community are eligible to receive funding for a full-time equivalent (FTE) staff member or contractor in accordance with the local position market, based on state needs.

  • The IA Performance Category Should Give Greater Weight for Registry-Related Measures and Apply IAs to Clinical Outcomes Data Registries The Coalition requests that CMS consider making several additional changes originally requested within our Proposed Rule comments.

  • The financial benefit of running Pheno is proven Clinical Outcomes Data Reporting by Customers Length of Stay–3.0 days1–2.6 days2–2.0 days3–1.8 days4 Cost Savings $6 3,100/patientTime to Optimal Therapy–26.4 hours4–22.1 hours2–17.7 hours5–17.3 hours1Days on Therapy (DOT) –4.7 days2–1.5 days7–1.0 days4Clinical data>75 publications & proof sources Commercial Experience>100 customers Notable KOLs (1) Truong et al.

  • Blockchain-Authenticated Sharing of Genomic and Clinical Outcomes Data of Patients With Cancer: A Prospective Cohort Study.

  • This is a RA with a planned award in 4th quarter FY22.Artillery Range Southeast MRS is 107 acers in size.

  • Mroz8:28 – 8:30 am254 BMP Versus Alternatives: Cost Savings and Clinical Outcomes Data in 137 ALIF Patients with Two-year Follow-upPaul J.

Related to Clinical Outcomes Data

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • 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 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.

  • 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.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • 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.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • 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.

  • 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.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Study Data shall have the meaning set forth in Section 8.1.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • 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 Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • 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;

  • Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.

  • Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.