Clinical Strategy

Contemporary drug development 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, in collaboration with reputable Clinical Research Organizations (CROs), work closely 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.

 

NGT provides clinical support in close concert with, as needed, other NGT functional areas such as Nonclinical Sciences, CMC, Quality & Compliance, and Regulatory Strategy & Submissions

PRECLINICAL DRUG DEVELOPMENT

EARLY AND LATE-STAGE CLINICAL DEVELOPMENT

REGISTRATION, COMMERCIALIZATION, AND POST LAUNCH:

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 partners with reputable CRO’s for these services.
Screen Shot 2022-06-23 at 6.23.37 PM

For more information
please contact:

Michael K. O'Brien, PhD

860.333.9023 ext. 402

OR Contact:

Rachel Franckowiak

Senior Director, Administration