Avance Clinical, the Australian CRO for biotechs, has expanded into North America with the acquisition of CRO partner company C3 Research Associates, enabling biotech clients a seamless journey from early phase to later phase studies. Avance Clinical has backing from private equity group Riverside Company for their global expansion program.
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Avance Clinical is the largest and most established full-service Australian and New Zealand CRO with a proven track-record of data acceptance by the FDA and all other major regulatory bodies.
The combined Avance Clinical Australia, New Zealand, and North American operations deliver a unique GlobalReady drug development model for biotechs.
Avance Clinical’s CEO Yvonne Lungershausen said: “Avance Clinical has been working with C3 Research Associates in recent years and they share a similar culture and focus on customer service and clinical excellence. This strong relationship made C3 Research Associates a natural acquisition choice for Avance Clinical’s expansion plans into North America. The due diligence process has taken more than 6 months and we are excited to now welcome our US team and offer the GlobalReady model for our clients.
“This acquisition gives our biotech clients conducting their early phase studies in Australia and New Zealand a seamless journey into the US to continue their clinical development programs, retaining the same high-quality CRO, which reduces time and cost and delivers quality FDA-accepted data. This GlobalReady model is designed to extend biotechs’ investments so they can achieve greater clinical development milestones with reduced spend, all with the assurance of FDA accepted data.
“In addition, the attractive 43.5% rebate on clinical spend in Australia, offers our clients the opportunity to utilize our North American operations expertise and team, whilst maintaining services in Australia to maximise their rebate potential.
“We often point to the fact that there are currently more than 280 Phase III global trials that have conducted their Phase I study in Australia, which again demonstrates Australian data acceptability with the FDA and other major regulatory authorities.
“We will be making significant investments in our US operations including growing the team to more than 120 people and leveraging their deep industry experience across a broad range of therapeutic areas, in particular oncology.
Clients can be assured the world-class best practice technologies, systems and processes will be integrated across all regions.”
This seamless GlobalReady journey is designed for success whereby biotechs can:
– Take advantage of the Australian early phase clinical trial landscape (No IND and 43.5% tax rebate)
– Transition or expand into North America for later phases – without changing CROs (retain study knowledge and processes/team)
– Seamlessly operationalise global dose-escalation and dose-expansion trials across the two regions
– Harness significant speed and cost advantages
– Be assured of quality data – transferable and readily acceptable by the FDA and other regulatory authorities
The Avance Clinical team offers exceptional study approval and success rates which can be attributed to its deep scientific expertise, advanced data technologies, knowledge of the Australian, New Zealand and North American regulatory environment, and its extensive relationships with sites and KOLs.
The company is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) which allows it to manage pre-clinical and clinical trials for vaccines and GMO therapies.
Avance Clinical’s has achieved high growth and industry-leading repeat business rates with its focus on gold standard technology paired with solution-orientated clinical experts. This is the mix that biopharma clients clearly require in this fast-moving, competitive and high-stakes sector.
Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.