Clinical Trials definition
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.
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).
Examples of Clinical Trials in a sentence
The descriptions of the results of the Clinical Trials described or referred to in the Offering Documents are accurate and complete in all material respects and fairly represent the published data derived from the Clinical Trials and neither the Company nor any Cybin Entity has knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Offering Documents.
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 human studies designed to measure the safety and/or efficacy of the Product. Clinical Studies include Phase I Clinical Trials, Phase II Clinical Trials, and Phase III Clinical Trials.
Clinical Trials means a Phase II Clinical Trial or a Phase III Clinical Trial.
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 a Phase 1 Trial, Phase ▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇/▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇ Trial or Phase 4 Trial, as applicable.
Clinical Trials means Phase I/II Clinical Trial, any Additional Pre-Pivotal Clinical Trial, and a Pivotal Clinical Trial.
Clinical Trials means human clinical trials conducted up through receipt of Regulatory Approval, including Phase 1 Clinical Trials, Phase 3 Clinical Trials, bioequivalence trials, and/or variations of such trials (for example, phase 2/3 studies). For clarity, the term ‘Clinical Trials’ shall not include Phase 4 Clinical Trials.