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 Trials means trials that: 1) have been subjected to independent peer-review of the rationale and methodology; 2) are sponsored by an entity with a recognized program in clinical research that conducts its activities according to all appropriate federal and state regulations and generally accepted standard operating procedures governing the conduct of participating investigators; and 3) the results of which will be reported upon completion of the trial regardless of their positive or negative nature.

Examples of Clinical Trials in a sentence

Clinical Trials This plan covers clinical trials as required under R.I. General Law § 27-20-60.
In the event that any such studies have been approved by Pfizer, Licensee will pay for any necessary supplies, and Licensee agrees to fully comply with all Applicable Law in connection with such Clinical Trials.
Unless specified otherwise in a writing signed by Pfizer, Pfizer will not be the sponsor or hold regulatory responsibility for such Clinical Trials and Licensee, pursuant to Section 9.3(a), shall indemnify Pfizer for any liability arising, directly or indirectly, from or based on the conduct of any Clinical Trial or study.
Without limiting the foregoing, in the event Pfizer approves any such studies or trials in accordance with this Section 3.3, then, at the option of Pfizer, Pfizer may, but shall have no obligation to, have its representative review any approved studies, but in no event will such activities relieve the sponsor of such Clinical Trials from their oversight and monitoring obligations.
Subject to Pfizer’s prior written approval (which may be provided or withheld in Pfizer’s sole discretion), Licensee may conduct basic research or pre-clinical, clinical or other studies (including Clinical Trials) with the Compound, Product or Licensed Product.

More Definitions of Clinical Trials

Clinical Trials means all Phase I/II Clinical Trials, Phase II Clinical Trials and Phase III Clinical Trials, or such analogous studies and trials of a medical device as are intended to establish scientifically valid evidence to be submitted in an application to a Regulatory Authority for the Product.

Clinical Trials means Phase 1 Trials, Phase 2 Trials, Phase 3 Trials, Phase 4 Trials, and/or variations of such trials (for example, Phase 3/4).

Clinical Trials means any and all human clinical trial of a compound, including without limitation Phase 1 Clinical Trials, Phase 2 Clinical Trials, Phase 3 Clinical Trials, Phase 4 Clinical Trials, bioequivalence trials, and/or variations of such trials (for example, phase 2/3 studies).

Clinical Trials means any administration of Licensed Products to humans for the purpose of demonstrating the safety or efficacy of the Licensed Product.

Clinical Trials means any clinical trial or any other test or study in human subjects, whether sponsor or principal investigator initiated, intended to determine the safety, tolerability, pharmacokinetics, efficacy, pharmacodynamics or benefit/risk analysis of a Licensed Product in human subjects as may be required by Applicable Law or recommended by a Regulatory Authority to obtain or maintain Regulatory Approval for a Licensed Product.