Clinical Strategy
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
PRECLINICAL DRUG DEVELOPMENT
- Clinical assessment of IND-enabling studies.
- Develop, write, and review clinical sections of IND, IMPD, and CTAs
- Develop, write, and review clinical sections for meeting packages and briefing books.
EARLY AND LATE-STAGE CLINICAL DEVELOPMENT
- Single point of contact to clinical study CRO’s.
- Therapeutic areas of expertise include, but are not limited to, oncology, rare diseases, CNS disorders, infectious diseases, cardiovascular disorders, renal disorders, metabolic diseases, and pediatrics.
- Develop Target Product Profile.
- Develop clinical plan and development strategy (Phase 1-4 studies) including study synopses / protocols, statistical analysis plan, safety monitoring plan, and site monitoring plan. Develop, write, and review Informed Consent material.
- Develop, write, and review clinical and safety sections of Investigator Brochure.
- Clinical data analysis and medical writing of Clinical Study Reports(Phases 1-4).
- Clinical and safety responses to Health Authority queries.
- Develop, write, and review clinical and safety sections of Breakthrough Therapy Designation Requests, Fast Track Designation Requests, Orphan Drug Development Requests, and Rare Pediatric Disease Designation Requests.
- Operations Strategy: project resource needs, clinical supplies, third party vendor selection, costs, and timelines for Phase 1-4 studies.
REGISTRATION, COMMERCIALIZATION, AND POST LAUNCH:
- In collaboration with NGT BioPharma Consultant's Regulatory Team and CRO’s we develop, write, and review the clinical and safety sections to Pre-NDA, BLA and MAA meeting requests, NDA, BLA and MAA submissions, labeling and promotional labeling reviews, and safety reports.
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.
