Clinical Development & Operations Strategy

Contemporary drug development emphasizes strategic, program-specific pathways designed to best match the disease to 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 (NGT), in collaboration with Clinical Research Organizations (CROs), work closely with our clients to provide the strategy and oversight needed to advance their early-stage clinical development candidates confidently towards first in human and Phase 1 studies (e.g., SAD / MAD, PK, drug interaction, special population and safety studies), proof-of-concept studies, registration trials, market access, and partner investment. We provide clinical support in close alignment with NGT consultants experienced in e.g.,
Preclinical, CMC, Regulatory, and Quality/Compliance to offer services that include, but are not limited to, the following:

Preclinical Drug Development
Registration, Commercialization, and Post Launch
Early-Stage and Late-Stage Clinical Development

NGT Clinical Development and Operations Strategy services do not include: (i) clinical site selection, 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 Niche Service Providers for these services.