Oncology-led Clinical Development · Vienna
Oncology-led
medical & clinical
expertise.
Alpsvia Solutions partners with biotech and pharmaceutical sponsors on development strategy, medical oversight and trial execution — anchored in oncology and extending across haematology, rare disease and other specialty therapeutic areas.
- Strategy
- Development planning
- Science
- Protocol & evidence
- Regulatory
- Pathway & interactions
- Delivery
- Operational oversight
Our approach
Scientific rigor.
Regulatory craft.
Operational realism.
We work as an embedded medical and strategic partner — small enough to be attentive, experienced enough to anticipate. Oncology sits at the centre of our practice, and that precision-medicine mindset extends to every haematology, rare disease and specialty program we support.
The deliverable is never a thicker deck. It is a development plan and a trial that your team can defend to investigators, ethics committees, regulators and partners — and execute with confidence.
What we do
Clinical development,
end to end.
Development Strategy
Target product profiles and integrated development plans for oncology and adjacent specialty indications.
Study Design & Protocols
Tumour-agnostic and biomarker-driven trial concepts, endpoint selection and protocol authoring across phases.
Clinical Operations
Trial start-up, site activation, monitoring and CRO and vendor governance with risk-based quality.
Medical Oversight
Senior medical monitoring, eligibility and safety review, investigator engagement and independent committee support.
Markets
Regulatory fluency
across three regions.
We guide sponsors through the agencies that shape modern drug development — translating clinical evidence into submissions that meet each authority's expectations and review culture.
United States · FDA
IND and NDA / BLA strategy, pre-IND and Type B / C interactions, and orphan and breakthrough designations.
European Union · EMA
Scientific advice, CTR submissions, national competent authority engagement and PRIME pathway support.
China · NMPA
CDE communication, IND and NDA filings and bridging-study strategy for Chinese registration.
Ready when you are
Let's talk through your next
development milestone.
Tell us where you are in your program. We'll respond within two business days.