Clinical Trial

Clinical Trial. A clinical investigation of a SYROS Product undertaken or supported by SYROS, alone or with a third party, as part of the development of such pharmaceutical product to obtain information relating to patient outcome and/or selection for therapy with such pharmaceutical product, which clinical investigation includes the use of the QIAGEN IVD or any prototype of it developed in the respective Project. For clarification, a Clinical Trial under this definition may include a bridging study or other... clinical performance study View More

Clinical Trial. Means Cartilage Analysis and Non-Cartilage Analysis that is performed for the purpose of understanding the efficacy of a disease modifying osteoarthritic drug in humans, intended and/or required to be submitted to a regulatory body as part of a drug approval submission. The paying entity for a Clinical Trial can be a pharmaceutical, biotechnology, or medical device company, or a governmental or non-governmental... research agency. View More

Clinical Trial. Corcept's Phase III clinical trial of the Drug Product.

Clinical Trial. Shall mean any trial for clinical development of pharmaceutical products defined as "Phase I," "Phase II," "Phase III," or "Treatment IND" in FDA regulations, as amended from time to time.

Clinical Trial. Means human clinical testing as determined by Immunicon for Immunicon Products and by Kreatech for Kreatech Products, meeting regulatory requirements and ethical guidelines as may be specified in individual countries where clinical trials with respect to such Immunicon Products or Kreatech Products will be conducted or where such trials will be used to seek approval under Regulatory Authority requirements to market, use and sell such Immunicon Products or Kreatech Products in such country.

Clinical Trial. A human clinical trial conducted in any country or countries in patients with a particular disease or condition with the purpose of establishing the safety and tolerability of an investigational drug and confirming or establishing its efficacy for such disease or condition.

Clinical Trial. Any human clinical trial in any country the results of which are to evaluate or establish safety, efficacy or dosing, including without limitation pursuant to 21 CFR 312.21, et seq. A "Phase III Clinical Trial" shall mean a pivotal human clinical trial in any country the results of which could be used to establish safety and efficacy of a Product as a basis for a BLA/MAA or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent

Clinical Trial. That certain clinical trial of the Study Drug, as described in the Protocol.

Clinical Trial. The clinical trial entitled "Dose Escalation Study of NK-92 Cell Infusions in Patients With Hematological Malignancies in Relapse After Autologous Stem Cell Transplantation" conducted at Princess Margaret Hospital, Toronto, Canada pursuant to that certain Clinical Trial Agreement (the "Clinical Trial Agreement") of even date herewith (herein, the "Clinical Trial Agreement")

Clinical Trial. A research study in humans that is (i) conducted in accordance with international ethical and scientific quality standards for designing, conducting, recording and reporting research studies that involve the participation of human subjects, which standards are established through the guidance of the U.S. Food and Drug Administration in the United States and other regulatory bodies as applicable, and (ii) designed to generate data regarding a chemical compound or biological molecule in support... of an NDA. View More