NGT BioPharma Consultants, in collaboration with reputable Clinical Research Organizations (CROs), work closely together with our clients to provide the strategy and oversight needed to confidently advance their early-stage clinical development candidates towards first in human and Phase 1 studies (e.g., SAD / MAD, PK, drug interaction, special population and safety studies), proof-of-concept studies, and registration trials.
Contemporary drug development for small molecules and biologics (Mabs, duobodies, proteins, cell therapy, gene therapy, and new modalities) emphasizes strategic, program-specific pathways designed to best match the disease and the medication under evaluation. With an emphasis on quality data, informed decision-making, and speed, early- and late-stage development needs to be seamlessly integrated and, at times, combined. NGT BioPharma Consultants provide clinical strategy support in close concert with, as needed, our other broad drug development functional areas such as Nonclinical Sciences, CMC, Quality & Compliance, and Regulatory Strategy & Submissions
NGT Clinical Development and Operations Strategy services do not include: (i) clinical site training and monitoring during the conduct of the clinical study; and (ii) medical / safety oversight, safety reporting, or data management. NGT BioPharma Consultants partners with reputable CRO’s for these services.