A specialist nucleic acid CRO, with trial AI that reduces risk before the first patient
Deep nucleic acid science, full CRO services, and in-silico trial modelling from a single Australian partner.
Built only for RNA and DNA medicine
Syngenis Clinical provides bespoke, end to end clinical research services exclusively for the development of RNA and DNA oligonucleotide therapeutics and diagnostics. These include antisense oligonucleotides, siRNA, microRNA and antimiR constructs, guide RNA, aptamers, PMOs and other functional nucleic acid modalities. Nucleic acid medicine is one of the fastest growing frontiers in healthcare, yet it remains one of the least well served by the clinical research industry. Most CROs are generalists that treat oligonucleotides as one modality amongst many. Syngenis Clinical is built specifically to close that gap.
Deep nucleic acid science, not
generalist coverage
The value a CRO brings to a nucleic acid program depends on how well it understands the modality. Oligonucleotides do not behave like small molecules, and they do not behave like biologics. Their pharmacokinetics are often driven by tissue distribution rather than plasma exposure, their bioanalysis demands specialist hybridisation and mass spectrometry assays, and their chemistry, manufacturing and controls, immunogenicity, and safety considerations are distinct. A CRO that treats an antisense oligonucleotide like any other drug introduces delay and risk. Syngenis Clinical does not, because we understand these molecules from the sequence up.
The advantage of a single scientific partner
Because Syngenis manufactures and characterises the material it studies, customers avoid the fragmentation, revalidation, and intellectual property exposure that arises when discovery, manufacture, and clinical development sit with different providers. The same team that understands your chemistry helps design the trial and guides it, from investigational material through to a regulator-ready clinical study report. Fewer hand-offs, fewer information gaps, one accountable partner, one chain of custody.
Syngenis Clinical is being established as a specialist nucleic acid CRO. Foundational clinical support services are currently being built and are expected to be operational in early 2027. We are currently accepting early-phase program scoping enquiries and invite you to contact us to discuss your requirements.
Full CRO services
Trial design and strategy, protocol, statistical analysis plan and core documents, with modality specific pharmacokinetic, pharmacodynamic, biomarker and endpoint strategy from the outset.- Study start up, site activation, investigator meetings, and electronic trial master file build.
- Data management and biometrics, including SDTM, ADaM and pharmacokinetic analysis, through to database lock.
- Safety monitoring, serious adverse event systems, and Safety Review Committee, DSMB or DMC set up.
- Central pharmacy, laboratory and imaging coordination, including the specialist bioanalytical assays oligonucleotide programs demand.
- Site and study management through dedicated clinical research associates.
- A regulator-ready clinical study report, and ongoing client support throughout.
The clinical development lifecycle fully supported
From feasibility and study start up through early phase and first in human, Phase II proof of concept, Phase III confirmatory studies and post marketing work, Syngenis Clinical can advance a nucleic acid program at every stage. It can come as a complete package or as individual functions that complement a sponsor's in-house team.
Trial AI and in-silico capability
We are progressively incorporating AI into trial design and delivery, and building selective in-silico capability, including virtual patient modelling and synthetic control arm approaches. These methods are particularly valuable for the small, rare disease populations that nucleic acid therapies so often target, where every participant is precious, and a conventional control arm may be hard to justify ethically, or practically. AI supports the science. It does not replace the rigour, oversight, and regulatory discipline behind it.
Assured regulatory and data integrity
We are conversant with the requirements of the TGA, FDA, and EMA. We work to ICH Good Clinical Practice, and to ISO 13485 for diagnostic programs. Our data management, statistical programming, and quality processes are built to preserve data integrity across the study record, supported by validated systems, audit trails, and controlled documentation.
One of the world's best places to run early phase trials
Australia is one of the most attractive destinations in the world for early phase clinical research. Under the Clinical Trial Notification scheme, many early phase trials can begin once a Human Research Ethics Committee has approved them, shaving months from start up. Data generated here is accepted by the FDA, EMA, and other major regulators. Add an ethnically diverse population, a world class health system, onshore sovereign material supply from Syngenis, and one of the world's most generous research and development tax incentives, and the case is compelling.
An advantage too good to overlook
For companies with aggregated turnover under $20 million, the Federal Government's Research and Development Tax Incentive is a refundable offset of up to 43.5 cents in every eligible dollar. On one million dollars of eligible trial expenditure, that is up to $435,000 returned, and because it is refundable, a pre-revenue company receives it as cash. Syngenis Clinical helps establish the eligible structure, register the activity, manage the program across the trial, and maintain the contemporaneous documentation a robust claim requires.
R&DTI figures are current for the 2025-26 and 2026-27 income years and are general information, not tax advice.
Reap the benefits of an integrated life sciences company
Talk to our team about your program, from candidate design to trial-ready material.