Clinical Trial Services definition

Clinical Trial Services means the Services described in Exhibit A to this Agreement, which shall serve as the Scope of Work and budget for this Agreement.
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Clinical Trial Services includes but not limited to (i) clinical supply optimization services, (ii) certain clinical manufacturing (e.g.: over encapsulation, placebo blending and dispensing), (iii) clinical primary packaging, (iv) clinical secondary packaging, (v) clinical label generation and labeling, (vi) storage of Client’s Product, (vii) clinical distribution (e.g:, project management, pick and pack), (viii) Qualified Person certification, (ix) returns management, and (x) destruction of Client’s Product, with one or all of which would be described within a Project Proposal.
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Clinical Trial Services means the Services described in Section 4 of this Agreement.
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Examples of Clinical Trial Services in a sentence

  • Radius and NB are parties to that certain Clinical Trial Services Agreement dated as of March 29, 2011 (the “CTS Agreement”) and a certain Work Statement NB-1 under the CTS Agreement.

  • Cross Country Healthcare’s Clinical Trial Services division includes US resourcing providers, ClinForce and Assent Consulting, whose services include contract staffing, permanent placement and functional service provision.

  • How to Contact Us:If you have any questions about this privacy notice, you may contact us at Eli Lilly European Clinical Trial Services S.A./N.V.; Rue Emile Francqui 3, B-1435 Mont-Saint-Guibert or via Tel+32 (0)1083 50 00 or privacy@Lilly.com.

  • Prior to or promptly following the Clinical Trial Service Period (with respect to Contracts pertaining to the Clinical Trial Services) and at any time during the Term (with respect to other Contracts), the Parties will agree on which Contracts, if any, need to be assigned by Seller to the Company (collectively, the “Assigned Contracts”).

  • The Zoning Administrator shall withdraw the Notice of Abandonment and Removal and notify the owner that the Notice has been withdrawn if the owner provides information that demonstrates to the satisfaction of the Zoning Administrator that the Small Wind Energy System has not been abandoned.

  • This Work Statement NB-1 is entered into pursuant to Section 2.1 of the Clinical Trial Services Agreement dated as of March 29, 2011, by and between Radius Health, Inc.

  • All terms and conditions set forth in the Master Agreement will remain in full force and effect with respect to Clinical Trial Services except as modified hereby.

  • For any Clinical Trial Services, these Supplemental Legal Terms and Conditions will control to the extent of any conflict with the terms of the Master Agreement.

  • As a result of the disposal, the underlying operations and cash flows of the Clinical Trial Services business have been eliminated from the Company’s continuing operations and the Company no longer has the ability to influence the operating and/or financial policies of the disposal group.

  • Section 8 of Schedule A is not applicable to Clinical Trial Services and does not apply.


More Definitions of Clinical Trial Services

Clinical Trial Services includes (i) Clinical Supply Optimization Services, (ii) certain clinical manufacturing, (iii) clinical primary packaging, (iv) clinical secondary packaging, (v) clinical label generation and labeling, (vi) storage of Materials or Product, (vii) clinical distribution (e.g., project management, pick and pack), (viii) qualified person certification, (ix) returns management, (x) destruction of Product, (xi) sourcing of CAM on behalf of Client, (xii) sourcing of comparators on behalf of Client for use in clinical trials and, (xiii) commercial packaging performed at a Clinical Trial Services Facility.
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Clinical Trial Services means those services provided to conduct NR's clinical trial entitled "A Phase II/III Multicenter, Randomized, Open-Label Trial Evaluating High Dose Melphalan plus Holmium-166-DOTMP versus High dose Melphalan alone in Patients with Multiple Myeloma when Given in Conjunction with Peripheral Blood Stem Cell Transplantation" (the "Trial"), including clinical project management, monitoring and site management, and administrative support; quality management, assurance and regulatory services to include document control, investigator files, and file and site audits; medical management and pharmacovigilence including [*] DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION. study set-up and maintenance, non-reportable SAEs and Clintrace set-up and maintenance; data management services including CRF design, database set-up and maintenance, data entry, data review and clean-up and clinical quality audits, project management, import of external data, and data transfers; biostatistics services including protocol review and/or writing, randomization plan and/or schedule, analysis plan, DSMB analyses, interim analysis, and final analysis; IVR system services including randomization; investigator meetings and services; patient participation; raw materials; product doses; IRB services; CRF printing and shipping; and other related costs or expenses to conduct the Trial approved in advance by PPD.
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Related to Clinical Trial Services

  • 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 any human clinical trial of a Product.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • 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;

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

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

  • 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.

  • 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.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • 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.

  • 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 the JDC 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.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • 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.

  • 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 I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • 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.

  • 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 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;

  • 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).

  • Clinical peer means a physician or other health care professional who holds a non-restricted license in a state of the United States and in the same or similar specialty as typically manages the medical condition, procedure or treatment under review.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Pre-Licensed Therapist means an individual who has obtained a Master’s Degree in Social Work or Marriage and Family Therapy and is registered with the BBS as an Associate CSW or MFT Intern acquiring hours for licensing. An individual’s registration is subject to regulations adopted by the BBS.