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- 862-258-5500
- tdsteele@outlook.com
Preclinical study design is one of the most critical determinants of a successful drug development program. Nonclinical Safety Solutions (NCSS) provides strategic planning, in-depth study design, and expert oversight for GLP and non-GLP programs, ensuring each study is scientifically justified, aligned with regulatory expectations, and structured to answer the questions that truly matter for clinical progression.
With more than 25 years of combined industry and FDA experience, Dr. Thomas D. Steele brings the regulatory insight, scientific rigor, and practical study execution expertise needed to optimize your nonclinical program and avoid costly development delays. NCSS evaluates your molecule, modality, and mechanism of action to determine the appropriate species, study duration, dose levels, endpoints, and PK/ADME integration, building a strong foundation for first-in-human decisions.
NCSS partners closely with developers, CROs, and internal scientific teams to maintain study quality, interpret emerging data, and resolve challenges as they arise. From early planning and protocol development to study monitoring and final reporting, NCSS helps companies reduce risk, strengthen scientific credibility, and ensure a smooth transition into clinical development.
Misaligned, underpowered, or poorly constructed preclinical studies are among the most frequent causes of IND delays, FDA questions, and costly development setbacks. NCSS ensures your studies are scientifically sound, strategically sequenced, and fully defensible under regulatory review.
Dr. Steele’s background—including FDA review experience, industry leadership, and hands-on study execution—allows NCSS to anticipate issues before they become barriers. Clients benefit from stronger safety justifications, more efficient timelines, and a higher degree of regulatory confidence.
If you’d like expert guidance during any stage of your nonclinical program, we invite you to request a consultation.
Typical requirements include repeat-dose toxicology, safety pharmacology, PK/ADME studies, and genetic toxicology, though specifics vary by molecule and therapeutic area.
Ideally during lead optimization or early candidate selection, ensuring timelines, species choices, and study rationale are aligned before key decisions are made.
Yes. NCSS recommends CROs based on study type, modality, budget, and timeline, and supports communication and oversight throughout study setup and execution.
NCSS evaluates emerging findings, identifies potential safety concerns, and provides recommendations for adjusting study design, dose levels, or endpoints.
NCSS specializes in troubleshooting ambiguous or concerning toxicology signals and can recommend follow-up analyses or mechanistic studies to address regulatory concerns.
Yes. NCSS supports discovery-level exploratory work, non-GLP mechanistic studies, and full GLP toxicology programs to ensure continuity across the entire nonclinical package.