Clinical Operations Sample Clauses

Clinical Operations. Regulatory Document Collection • Pre-study regulatory documents for each site will include accurate, signed Form FDA 1572, financial disclosure agreement, curricula vitae from the principal investigator and other relevant site personnel, site-specific informed consent form, IRB approval, etc.
Sample 1
AutoNDA by SimpleDocs
Clinical Operations. Site Initiation Visits (SIVs) Performance of an onsite visit for each clinical trial site Interim Monitoring Visits (IMVs) Performance of 14 IMVs per site with a frequency of 6-8 weeks Close Out Visits (COVs) Performance of a one-day COV for each site In-house Site Management Maintenance of contact with each site beginning with essential document collection and continuing until the database is locked
Sample 1
Clinical Operations. The Company shall, and shall cause the Group Companies to, implement policies and standard operating procedures for the management, collection, use, transfer and disposal of research data, clinical data and other data protection requirements. The Company shall, and shall cause the Group Companies to implement internal policies to ensure that for any Protected Health Information (“PHI”), as defined by HIPAA (or similar law outside the United States, as applicable), the Group Companies shall obtain or cause to be obtained (prior to accessing PHI or providing such PHI access) from each such subject an authorization in compliance with HIPAA (or similar law outside the United States, as applicable) sufficient for access, license and use of such information, or, to the extent applicable, waiver of authorization from an institutional review board or privacy board.
Sample 1
Clinical Operations. Oramed Medpace N/A Item Description X Clinical trial management Provide overall study management for 10 sites X Project website Medpace to develop secure, project-specific website containing relevant information and tools X Newsletters 6 monthly electronic newsletters X Ongoing essential document collection Ongoing collection and maintenance of site-specific documents X Tracking of study medication shipments Assumes 2 shipments per site for 10 sites X Supply, packaging, and labeling of study medication Assumes Medpace will contract and manage packaging, labeling and drug depot vendor X Storage and distribution of Study medication Assumes Medpace will contract and manage vendor to perform packaging, labeling and drug depot services
Sample 1
Clinical Operations. CO049 SB939-2006-001 Trial Master Files - Site Level (Chuah and Toh) SB939-15 CO050 SB939-2006-001 Trial Master Files - Site Level (Koh) SB939-16 CO051 SB939 Investigator Sponsored Studies Trials SB939-17 CO053 SB939-2006-001 Trial Master File - Site Level (Xxxxxxx) SB939-18 CO054 SB939-2006-001 Trial Master File - Site Level (Xxxxxx Xxxxxx 1 of 2) SB939-19 CO055 SB939-2006-001 Trial Master File - Site Level (Xxxxxx Xxxxxx 2 of 2) SB939-20 CO056 SB939-2006-001 Pharmanet Trial Master Files - Safety (Box 1 of 6) SB939-21 CO057 SB939-2006-001 Pharmanet Trial Master Files - Safety (Box 2 of 6) SB939-22 CO058 SB939-2006-001 Pharmanet Trial Master Files - Safety (Box 3 of 6) SB939-23 CO059 SB939-2006-001 Pharmanet Trial Master Files - Safety (Box 4 of 6) SB939-24 CO060 SB939-2006-001 Pharmanet Trial Master Files - Safety (Box 5 of 6) SB939-25 CO061 SB939-2006-001 Pharmanet Trial Master Files - Safety (Box 6 of 6) SB939-26 CO062 SB939-2006-001 Trial Master File - Protocol Level SB939-27 CO063 SB939-2006-001 Trial Master File - Protocol Level SB939-28 CO064 SB939-2006-001 Pharmanet Trial Master Files - Data Management (1 of 2) SB939-29 CO070 SB939-2006-001 Pharmanet Trial Master Files - Data Management (2 of 2) SB939-30 A request for confidential treatment has been made with respect to portions of the following document that are marked with [*CONFIDENTIAL*]. The redacted portions have been filed separately with the SEC. CO071 SB939-2006-001 PK Analysis SB939-31 US00l SB939-2006-001 Miscellaneous TMF documents received after archival (to be incorporated into TMF)
Sample 1
Clinical Operations. The Group Companies shall, as soon as practical after the Closing, issue and implement policies and standard operating procedures for the management, collection, use, transfer and disposal of research data, clinical data and other data protection requirements. The Group Companies further agree that, as soon as practical after the Closing, they shall develop internal policies to ensure that for any Protected Health Information (“PHI”), as defined by HIPAA (or similar law outside the United States, as applicable), the Group Companies shall obtain or cause to be obtained (prior to accessing PHI or providing such PHI access) from each such subject an authorization in compliance with HIPAA (or similar law outside the United States, as applicable) sufficient for access, license and use of such information, or, to the extent applicable, waiver of authorization from an institutional review board or privacy board.
Sample 1

Related to Clinical Operations

  • Synchronization, Commissioning and Commercial Operation 4.1.1 The Power Producer shall give at least thirty (30) days written notice to the SLDC and GUVNL, of the date on which it intends to synchronize the Power Project to the Grid System.

  • Commercial Operation On or before December 31, 2023, Interconnection Customer must demonstrate commercial operation of all generating units. Demonstrating commercial operation includes achieving Initial Operation in accordance with Section 1.4 of Appendix 2 to this ISA and making commercial sales or use of energy, as well as, if applicable, obtaining capacity qualification in accordance with the requirements of the Reliability Assurance Agreement Among Load Serving Entities in the PJM Region.

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • INTERNET PLANNING, ENGINEERING AND OPERATIONS ‌ Job Title: Internet/Web Engineer Job#: 2620 General Characteristics Integrally involved in the development and support of all Internet/Intranet/Extranet sites and supporting systems. Works closely with other IT groups and customers to define the system design and user interface based on customer needs and objectives. Participates in all phases of the development and implementation process, and may act as a project manager on special projects. Ensures the integration of the Web servers and all other supporting systems. Responsible for system tuning, optimization of information/data processing, maintenance and support of the production environment.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Trials The Ship shall run the following test and trials:

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • Verizon Operations Support Systems Verizon systems for pre- ordering, ordering, provisioning, maintenance and repair, and billing.

Time is Money Join Law Insider Premium to draft better contracts faster.