Biotechs get scalable early to late phase clinical offering from Cromos Pharma and Avance Clinical collaboration in Australia and Europe
October 8, 2020
Two dominant regional contract research organizations (CRO), Avance Clinical and Cromos Pharma, with operations in Australia and Central/Eastern Europe, respectively, are successfully collaborating on a scalable clinical solution for biotechs.
Dublin/Ireland – Adelaide/Australia – Two dominant regional contract research organizations (CRO), Avance Clinical and Cromos Pharma, with operations in Australia and Central/Eastern Europe, respectively, are successfully collaborating on a scalable clinical solution for biotechs.
The collaboration allows biotechs to quickly
start their pre-IND early phase studies in Australia, then expand to
Central/Eastern Europe to access the large patient populations for their Phase
2 and 3 studies.
Importantly, the AU/EU model allows
biotechs to keep their data and trial management in Australia, and take
advantage of the Australian cash rebate of up to 43.5% on clinical trial costs,
throughout all study phases, across both regions.
“We are very excited about this model that
seamlessly incorporates two of the most compelling and complementary
international clinical research hubs for our biotech clients from early to late
phase studies,” said Yvonne Lungershausen, CEO of Avance Clinical. “Our eClinical
and early phase expertise is well augmented by Cromos Pharma’s track record in
late stage trials and rapid enrollment capabilities,” she continued.
“We have been collaborating with Avance
Clinical and referring clients to each other for years,” remarked Vlad Bogin,
CEO of Cromos Pharma. “But it was a true Eureka moment when we realized that combining
Australia’s 43.5% tax rebate with Central/Eastern Europe’s unbeatable
recruitment rates is a paradigm shift in how clinical trials should be
conducted,” he concluded.
Cromos Pharma can access hundreds of millions
of patients via more than 2,500 sites in Central/Eastern Europe.
Pharma provides tailored and effective clinical trial solutions to support the
development of drugs that transform healthcare.An international
CRO with over 15 years’ experience, we offer fully integrated services performing
all aspects of clinical trials in all clinical phases and in a wide range of
therapeutic areas. Cromos Pharma delivers rapid recruitment and excellent
patient retention as well as expert study design and management. Cromos Pharma
has strong regional experience in Central and Eastern Europe with global
coverage provided by its US bases in Portland, Oregon and Miami, Florida.
Cromos Pharma’s European HQ is in Dublin, Ireland. At Cromos Pharma, we know
how important your product is. When the stakes are this high, you need a
International expertise combined with
in-depth regional knowledge in Central and Eastern Europe (300+ clinical trials
conducted in 70+ indications).
PI/site and patient network (40,000+ patients
enrolled from nearly 2,500 trial sites).
patient recruitment – our team met or
shortened project timelines in 95% of conducted trials.
Responsible recruitment is supported
by Cromos Pharma’s “No Patients-No Payments” initiative – a unique risk-sharing
Extremely short startup timelines (e.g. Georgia where we assure a study
launch in less than 2 months).
Expertise in innovative, generics and biosimilar
global studies (NDAs, ANDAs, BLAs, 505b2).
Regulatory inspections and audits that
attest to the highest quality of data: EMA in 2019 (1-week oncology site
inspection); FDA in 2017 (2-week oncology site inspection).
Clinical Development Strategy – we provide
expert guidance on study design, favorable venues, local and global landscape
to improve study outcomes.
About Avance Clinical www.avancecro.com
Australia’s Avance Clinical has more than 20-years of experience and is now one
of Australia’s leading Contract Research Organizations for biotechs. Avance
Clinical is committed to providing high-quality clinical research services with
its highly-experienced team.
The collective pool of knowledge and experience at Avance Clinical continually
grows through the careful selection of experts who also demonstrate passion in
their chosen field.
Avance Clinical offers high-quality services in an established clinical trial
ecosystem, that includes world-class Investigators and Sites able to access
specialized patient groups.
Other benefits include:
1. The Government R&D grant means up to 43.5% rebate on clinical trial
2. eClinical solutions capabilities – speed and continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class Investigators and
7. Established healthy subject databases and specialized patient populations
8. Five independent Phase 1 facilities across Australia including
hospital-based units for critical care
9. Major hospitals with world-class infrastructures and dedicated Clinical
Trial Units with a long track-record in FDA compliant research
10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies
year-round by taking advantage of Australia’s counter-flu and allergy seasons