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

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

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 study protocols, reviewing essential documents and prepping sites for activation.
* Reduced compliance risk and achieved zero errors by preparing necessary regulatory documents, compiling submission dossiers and managing responses with regulatory authorities
* Decreased cost to sponsors by up to 30% by enabling sponsors to leverage full-service CRO services and avoiding standalone contracts with independent regulatory affairs agencies.

Avance Clinical's Chief Scientific Officer Gabriel Kremmidiotis explains the biotech services offered by the Avance Clinical in-house Scientific and Regulatory Affairs team, including:
- Regulatory Strategy Development: Devising regulatory strategies to navigate diverse regulatory landscapes, ensuring timely submissions and approvals.
- Liaison with Regulatory Authorities:  Serving 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 clients a streamlined and flexible marketing application experience through our fully integrated functions within SRMA, harnessing our comprehensive global expertise.
- Adherence to GCP Standards: We utilize quality systems and uphold adherence to Good Clinical Practice (GCP) standards, safeguarding the integrity and ethical conduct of clinical trials.

Avance Clinical is focused on accelerating drug development for its biotech clients, from preclinical stages through to later phase trials. Avance Clinical recently:
- Opened clinical operations in South Korea
- Signed an MOU with CNS specialist European CRO Julius Clinical

Avance Clinical’s CEO, Yvonne Lungershausen, said, "There is a clear 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, make us an ideal CRO partner for later-phase biotechs seeking access to significant patient populations.

"Our global teams offer world-class data and seamless geographic expansion to accelerate drug development programs and position for success. Avance Clinical's high-quality study data is accepted by the main regulatory authorities including the EMA and FDA. 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.

"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. 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.

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 completing Phase I to Phase III of their drug development program, which 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, 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 high-quality results 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. Some of the technology partners are Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta and Medrio.