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Clinical Development
Expert Clinical Insights
Clinical Development Support
Moving a program into the clinic, or through a critical clinical milestone, requires more than strong science in any one function. It requires CMC, quality, nonclinical, and regulatory work streams to land in sync, on a timeline that often has no room for rework. PharmiOnyx supports organizations through this coordination, drawing on experience across CROs and global pharma and biotech, including direct work on global clinical programs for both small and large molecules at Takeda.
We act as the connective layer between your scientific teams and your regulatory submission, making sure the CMC story, the nonclinical data package, and the clinical protocol are aligned and internally consistent before they reach a regulatory agency or an investigator site.
IND Enabling Package Coordination
We help coordinate the cross-functional package required to support an IND filing, ensuring CMC, nonclinical, and clinical content are consistent with each other and the overall development narrative, and flagging gaps before they become review delays.
Investigator Brochure CMC Content
We author and review the CMC sections of the Investigator Brochure, ensuring drug substance and drug product information is accurately and clearly represented for clinical site and investigator use.
Clinical Trial Readiness Assessment
We conduct readiness assessments ahead of first in human and other key clinical milestones, reviewing CMC, quality, and regulatory status against the proposed clinical timeline to identify risks before they cause a delay.
Cross-Functional Regulatory Alignment
We help align development, quality, and regulatory teams around a shared CMC and clinical narrative, reducing the back and forth that happens when functions work from different assumptions about what the data supports.
Protocol Input from a CMC and Quality Perspective
We provide input into clinical protocol development where CMC and product quality considerations intersect with clinical design, such as formulation stability during the study period, dosing form considerations, and supply chain feasibility.
Global Program Coordination
We support coordination across global clinical programs spanning small and large molecules, helping ensure regional regulatory and CMC requirements are reconciled rather than addressed in isolation.
Who we work with: biotech teams preparing their first IND filing who need cross-functional coordination they don't have in-house, and pharma organizations running global clinical programs who need an experienced outside perspective to catch misalignment between CMC, quality, and clinical work streams before it reaches a regulatory agency.
"Looking for bioanalytical, PK/PD, or GLP toxicology study support instead? See Bioanalytical Development."
