Clinical Study definition

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

Clinical Study means a Xxxxx 0 Xxxxx, Xxxxx 2 Study, Phase 3 Study, Post-Marketing Study, Supplemental Study or other study (including a non-interventional study) in humans to obtain information regarding the product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of the product.

Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

Examples of Clinical Study in a sentence

• Moreover, if publication of the Clinical Trial to the peer reviewed literature has not occurred within twelve (12) months of Clinical Trial completion, Xxxxxxx or its designee may post the results of the Clinical Trial to a clinical trial results web site in the form of a Clinical Study Report Synopsis in ICH-E-3 format, if applicable.

• In the event of a conflict between the terms this Agreement and the terms of Pharmacovigilance Agreement, the Pharmacovigilance Agreement shall supersede to the extent related to pharmacovigilance matters associated with any Clinical Study and the terms of this Agreement control with respect to any other matters.

• Initiation of first Clinical Study of the Licensed Asset or a Product in the Licensed Territory XENCOR may exercise its option in accordance with Section 9.2.1(a).

• The Parties entered into Medical Device Clinical Investigation Agreement on 26 November 2021 (hereafter referred to as “Agreement”) entitled PULSE-EU, Prospective, Non-Randomized Clinical Study To Assess Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Persistent or Paroxysmal Atrial Fibrillation.

• The Parties agree to assist each other in conducting the Clinical Study and to resolve any disputes or differences of opinion about work procedures and methods through their usual negotiations.

More Definitions of Clinical Study

Clinical Study means any human clinical trial of a Product Candidate.

Clinical Study means any study in which human subjects are dosed or treated with a drug or biological product, whether approved or investigational.

Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

Clinical Study means any investigation in relation to humans intended:

Clinical Study means a Phase I Clinical Study, Phase II Clinical Study, Phase III Clinical Study or any other study in which human subjects or patients are dosed with a drug, whether approved or investigational.

Clinical Study means a Phase I Clinical Study, Phase II Clinical Study, Phase III Clinical Study, Phase IV Clinical Study or any other study in which human subjects or patients are dosed with a drug, whether approved or investigational.

Clinical Study means the investigation as defined in the cadre above, (also) to be conducted at the Study Site in accordance with the Protocol;