Clinical Validation definition

Clinical Validation means activities conducted to demonstrate that the RMS Product may be used to detect EZH2 change of function mutations in the catalytic domain through testing of Samples, including Clinical Samples, as well as the comparison of data from testing of Samples, including Clinical Samples, with the RMS Product and a comparator product or other sequencing assay.
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Clinical Validation means the satisfactory operation (as reasonably determined by EyeSys) of the Handheld System in a clinical setting by an eye care professional. In the event that EyeSys modifies the appointment of Distributor hereunder from an exclusive to a non-exclusive basis with respect to the Handheld System pursuant to this Agreement or terminates such appointment, EyeSys shall be required to refund a pro rata portion of the Exclusive Distribution Fee actually received by EyeSys calculated based upon the portion of the three-year period described in Section 3.2 which has then elapsed. In the event that the Commercialization Date shall not have occurred on or prior to March 31, 1998, EyeSys shall repay to Distributor, on or before April 5, 1998, the entire Exclusive Distribution Fee actually received by EyeSys.
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Examples of Clinical Validation in a sentence

  • Except as otherwise expressly provided in the Project Plan, RMS or its Affiliates is solely responsible for the manufacture and supply of the RMS Product to the Contract Laboratories for Clinical Validation or other similar activities involving use of the RMS Product under the Project Plan.

  • Subject to applicable law and regulations and any applicable existing contractual obligations, Pharmaceutical Partners will provide RMS with access or otherwise make available Clinical Samples to be used by RMS solely for the Clinical Validation to be performed under the Project Plan.

  • For Assay Development, including Clinical Validation of the Assay or similar activities involving the RMS Product under the Project Plan, RMS and its Affiliates shall be responsible for initially identifying and for contracting with the Contract Laboratories.

  • RMS shall be responsible for and shall conduct the Assay Development as set forth in the Project Plan, including the Clinical Validation of the RMS Product.

  • RMS will be responsible for providing training, support and any software upgrades to the Contract Laboratories to perform Clinical Validation or other similar activities involving use of the RMS Product under the Project Plan.

  • BRNI will provide Services to use two BRNI Biomarkers (PKC epsilon and Morphometrics) to assay all skin samples obtained for a Clinical Validation Trial (See Attachment B 1 below) to diagnose Alzheimer’s Disease (AD) patients in discrimination from age-matched controls and non-AD dementias such as those due to Huntington’s Chorea, P▇▇▇▇▇▇▇▇’▇ disease, and/or JakobCreuzfelt disease.

  • Table 13: Event Rates at 6, 12, 24 and 36 Months for the Composite Endpoint of All-Cause Mortality and All-Cause Hospitalization, by Galectin-3 Category and NT-proBNP level, for HF Subjects in the Clinical Validation Study.

  • This stage will include all Design Verification and Clinical Validation Studies Stage 5 CDx Approval and Product Implementation Product Implementation into the US will follow approval of the PMA approval and agreement on the device labelling with CDRH For the EU development data used to support the US PMA application will be used to generate a technical file in compliance with the Essential Requirements Checklist.

  • The fees payable by Pear to Licensor for clinical validation and consulting services (the "Clinical Validation Fees") shall be set out in a mutually acceptable Statement of Work provided to Pear pertaining to clinical services, upgrades or other requested services.

  • This stage will include all Design Verification and Clinical Validation Studies Product Implementation into the US will follow approval of the PMA approval and agreement on the device labelling with CDRH For the EU development data used to support the US PMA application will be used to generate a technical file in compliance with the Essential Requirements Checklist.