- Affecting Drug Development Schedules and Financial Plans
Avance Clinical, the leading Australian and North American CRO for biotechs announced today that new industry analysis shows 60-65% of US biotechs face challenges identifying the right sized CRO partner that can deliver at every phase of their drug development program. The report found this directly affected clinical programs and budgets.
The report also found that 50% of biotechs engaged with more than one CRO over the course of their clinical program potentially impacting knowledge transfer, timelines and budget.
The new analyst report from Frost & Sullivan examined the challenges biotechs face during the CRO selection process saying “biotechs are increasingly wanting to partner with mid-sized, agile, and responsive CROs with a proven ability to rapidly advance quality clinical programs”.
“There is a perception among biotechs that large multinational CROs are less responsive and unable to adapt to the fast-paced nature of biotech demands,” according to the report.
Additionally, it noted that biotechs currently faced multiple challenges including a decline in biotech funding, a rise in drug development complexity, evolving FDA regulatory review processes, and costly delays caused by slow patient recruitment.
The report concluded that biotechs, especially those aiming to meet investor milestones, need to select the right CRO from the start.
The report outlined the key criteria US-biotechs use to identify the right CRO including:
1. Established site relationships
2. Scientific excellence
3. Quality compliance and data excellence
4. Cost competitive
5. Patient recruitment solutions
6. Agile and responsive
7. Accelerated timelines
8. Regulatory approval track-record
9. Ability to expand to multi-regional global phases
10. Access to latest technologies (including Artificial Intelligence & Machine Learning)
The report emphasized that biotechs were seeking CROs with established site relationships and highlighted that Avance Clinical now has more than 1,250 US-based sites in their GlobalReady Site Partnership Program to support US biotechs accelerate their clinical trials.
Each site has been accredited by Avance Clinical for data quality, patient centricity, and streamlined processes designed meet rigorous clinical timelines.
In addition, the report found a regulatory affairs track-record was a key selection criteria saying in-house regulatory expertise was the most attractive option for biotechs. It found that Avance Clinical is one of the only Australian/US mid-sized CRO with an inhouse regulatory affairs team experienced in FDA, EMA and China FDA approval processes.
Avance Clinical presented the report at JPM and Biotech Showcase 2024 where the team is taking meetings.
Avance Clinical has been recognised by Frost & Sullivan for the past 4 years with the prestigious Frost & Sullivan Asia-Pacific CRO Best Practices Leadership Award.
CEO Yvonne Lungershausen said “We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biotech clients need for clinical success”.
“Avance Clinical’s 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,” she said.
GlobalReady 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.
GlobalReady also enables US biotechs to conduct their mid to late phase studies in the US and expand to multi-regional locations.
In addition, the attractive 43.5% rebate on clinical spend in Australia, offers clients the opportunity to utilize our North American operations expertise and team, whilst maintaining services in Australia to maximise their rebate potential.
Find out more:
- Learn about the GlobalReady model here https://www.avancecro.com/avance-clinical-north-america-operations/
- For more information about the benefits of running your next study with Avance Clinical contact us: enquiries@avancecro.com
About Avance Clinical
Avance Clinical is the largest premium full-service Australian and North American CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company’s clients are biotechs completing Phase I to Phase III of their drug development program that requires fast, agile, and adaptive solution-oriented clinical research services.
Frost & Sullivan Awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past four years, has been providing CRO services in the region for more than 26 years.
Pre-clinical through to mid to late phase
Avance Clinical offers pre-clinical services with their experienced ClinicReady team right from pre-clinical through to Phase III clinical services leveraging significant Australian Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.
With experience across more than 120 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.
Technology
Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners.
Media Contact:
Avance Clinical
Kate Thompson
media@avancecro.com