WebApr 13, 2024 · Robert Barrie. Novaliq has announced results from a pivotal Phase III trial for CyclASol showing improvement in patients with dry eye disease (DED). The positive results, published in the Journal of the American Medical Association Opthalmology, is a milestone for the drug which has a Prescription Drug User Fee Act (PDUFA) action date of June 8 ... WebGCP Auditing. When conducting clinical trials on investigational medicinal products or devices, you are required to show the planning, study conduct, performance, monitoring, auditing, analysis, and reporting all meet the ethical and scientific standards for Good Clinical Practice (GCP). As new technologies transform the way clinical research ...
Strategic Consulting - Clinical Trial Planning and Design
WebApr 13, 2024 · Allegro Ophthalmics has its sights set on a Phase II/III trial in dry age-related macular degeneration (AMD) after receiving a regulatory stamp of approval. Allegro announced that the US Food and Drug Administration (FDA) agreed that the company’s proposed Phase II/III protocol in dry AMD was acceptable for a study supporting eventual … WebLMK Clinical Research Consulting is a leader in Trial Master File (TMF) document management services and solutions for the life sciences industry. Inspection Readiness Our experts can support your TMF strategies in numerous … gerard butler and shanna moakler photos
CRC – Clinical Research Consulting
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