Therapeutic Expertise
Complex Routes of Administration
We run trials for products delivered by challenging routes — inhaled, intranasal, intrathecal, ophthalmic, transdermal, implantable and drug-device combinations — where administration itself is part of the science.
Complex delivery routes introduce unique PK, safety and usability considerations, and often bring device and human-factors requirements. Our physicians and operations teams design protocols that account for local and systemic exposure, administration training, and combination-product regulatory expectations.
Addressing common pain points in complex routes of administration clinical trials
Characterising local vs systemic exposure
Non-standard routes complicate PK interpretation and safety assessment.
We design sampling and modelling strategies tailored to the delivery route and target tissue.
Device and human-factors requirements
Drug-device combinations must demonstrate safe, reproducible administration.
We build human-factors and training considerations into the protocol and site workflows.
Combination-product regulatory complexity
Combination products face overlapping drug and device regulatory expectations.
Our regulatory team aligns the plan with combination-product guidance across jurisdictions.
The iNGENū CRO difference
Australian expertise, direct FDA submission
We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Trial data from Australia can be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.
iNGENū takes a highly strategic and disciplined approach to clinical research, ensuring every dollar is directed toward generating meaningful outcomes — eliminating unnecessary costs while maintaining the highest scientific and regulatory standards across the Asia-Pacific region.
“We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug — medical writing, project management, clinical data management and full end-to-end execution and monitoring. We have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads during this clinical trial.”
Giles MossChief Executive Officer
Ready to discuss your Complex Routes of Administration clinical trial?
Talk to our team about how iNGENū CRO can accelerate your research.
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