POC Clinical Trial definition

POC Clinical Trial means a clinical trial generally consistent with 21 CFR § 312.21(b) (or the corresponding foreign regulations that is required for receipt of Regulatory Approval of a product and the FDA or other applicable Regulatory Authority permits to be conducted under an open IND), for which (a) the principal purpose of which is to make a preliminary determination about such product’s efficacy and that is intended to explore one or more doses, and is prospectively designed to generate sufficient data (if successful) of clinical activity and safety in such patient population; and (b) such clinical trial shall be a randomized and placebo controlled clinical trial unless the FDA or other applicable Regulatory Authority indicates (based upon meeting notes, special protocol assessment or other written acknowledgement) that the FDA or other applicable Regulatory Authority will accept a single arm clinical trial for Regulatory Approval.
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POC Clinical Trial means one or more Clinical Trials in which patients are treated with the [***] Product that has in aggregate either: (a) [***], or (b) [***].
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POC Clinical Trial means a Clinical Trial intended as a registration trial that will form the basis for obtaining Approval, whether or not such Clinical Trial is designated as a Phase III Trial.
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Examples of POC Clinical Trial in a sentence

  • AskBio shall provide Selecta with an initial report of the results of such POC Clinical Trial, including top-line data (“Initial POC Trial Report”), within fifteen (15) days after completion of each POC Clinical Trial, and a final report of the results of such POC Clinical Trial within thirty (30) days of completion of each POC Clinical Trial (“Final POC Trial Report” and, together with the Initial POC Trial Report, the “POC Trial Reports”).


More Definitions of POC Clinical Trial

POC Clinical Trial means a Proof-of-Concept (“POC”) Clinical Trial for a Licensed Product in human patients in any jurisdiction of the Territory with a defined dose or a set of defined doses of such Licensed Product designed or intended to ascertain efficacy and safety of such Licensed Product for the purpose of submitting applications for Regulatory Approval to the applicable Regulatory Authorities. For the avoidance of doubt, a POC Clinical Trial is a pivotal study intended to lead to Regulatory Approval by a Regulatory Authority in a specific region and bridging data from a global Clinical Trial. “Clinical Trial” is defined as “any clinical trial in humans that is conducted in accordance with GCP and is designed to generate data in support or maintenance of an IND or MAA, or other similar marketing application, including any “phase 1 clinical trial”, “phase 2 clinical trial”, “phase 3 clinical trial”, or any post-approval clinical trial in humans.
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Related to POC 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.

  • 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 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.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such 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.