4 June 2024

New Research Launched at BIO24 Finds CROs with In-house Regulatory Affairs Deliver 30% Savings, Halve Timelines and Cut Risk for Biotechs

New Research Launched at BIO24 Finds CROs with In-house Regulatory Affairs Deliver 30% Savings, Halve Timelines and Cut Risk for Biotechs

Adelaide, Australia | North Carolina, USA

Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, is sharing new data at BIO 2024 from Frost & Sullivan research showing biotechs save more than 30% in costs and halve start-up times with CROs that have in-house scientific and regulatory affairs.

Meet the team at BIO 2024 Booth #5601

Get first access to the new Regulatory Affairs Benefits data report

According to the report key benefits for biotechs with CROs that have in-house scientific and regulatory affairs included:

  • Decrease trial startup timelines by up to 50% by supporting sponsors in preparing the study protocols, reviewing essential documents and prepping site for activation.
  • Reduced compliance risk and achieve zero errors by preparing necessary regulatory documents, compile submission dossiers and manage responses with regulatory authorities
  • Decreased cost to sponsors by up to 30% by enabling sponsors to leverage benefits of full-service CRO services and avoiding standalone contracts with independent regulatory affairs agency.

Download the new Regulatory Affairs Benefits data report

Avance Clinical’s Chief Scientific Officer Gabriel Kremmidiotis said some of the biotech services offered by the Avance Clinical in-house Scientific and Regulatory Affairs team included:

  • Regulatory Strategy Development: We devise regulatory strategies to navigate diverse regulatory landscapes, ensuring timely submissions and approvals.
  • Liaison with Regulatory Authorities: We serve as the primary liaison between our clients and regulatory authorities, maintaining open lines of communication and addressing inquiries promptly.
  • Surrogate Development: Acting as a surrogate development department, we assist start-up companies in demonstrating safety and preliminary clinical proof of concept of their assets.
  • Streamlined Marketing Application: Our medium-term aim is to offer a streamlined and flexible marketing application experience to our clients through our fully integrated functions within SRMA, harnessing our comprehensive global expertise.
  • Adherence to GCP Standards: We utilize quality systems that uphold adherence to Good Clinical Practice (GCP) standards, safeguarding the integrity and ethical conduct of clinical trials.

Avance Clinical recently:

Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to later phase trials.

Avance Clinical CEO, Yvonne Lungershausen said “It’s clear there is a demand for a mid-sized, agile, and responsive CRO with an in-house regulatory affairs team, and a proven track record of swiftly advancing high-quality clinical programs”.

“Our Australian and New Zealand operations have been delivering successful early phase clinical trials for decades, while our European and North American operations as well as our new Asia operations makes us an ideal CRO partner for later phase biotechs that are seeking access to significant patient populations,” she said.

“Our global teams offer our biotech clients world-class quality data and seamless geographic expansions to accelerate their drug development programs and position for success.”

“Avance Clinical’s study data is accepted by all the main regulatory authorities including the EMA and FDA.”

“Biotechs are looking for a partner that can start fast with high-quality data that is readily accepted by the US FDA and other regulatory agencies. “Backed by our in-house global regulatory affairs team, we can navigate biotechs through regulatory complexities with confidence including FDA, EMA, MFDS and TGA submissions,” she said.

“In addition, our GlobalReady Site Partnership Network of over 2,500 highly qualified sites across the globe ensures maximum efficiency and effectiveness for our biotech clients’ trials.”

Lungershausen said this is our GlobalReady program and we currently have more than 90 biotech clients leveraging this unique, streamlined multi-phase and multi-region process. “With a globalized strategy, we ensure efficiency every step of the way,” she said.

Find out more:

  • Learn about the GlobalReady model
  • For more information about the benefits of running your next study with Avance Clinical contact us
  • Request a Proposal here

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.

Download the whitepaper Unlocking Biotech Success

Unlocking Biotech success - whitepaper
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