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Who we are

Accelagen is a leading global contract research organisation (CRO). Our mission is to co-create meaningful outcomes that have a tangible impact on the future of human health.

We build a comprehensive picture of the end goal that aims to define your ambitions and key milestones, with a focus on what the product would look like on the shelf. From there, we work backwards to map the
steps to achieve market approval, eliminating re- submissions and delays
to approvals.

Through expert consultation and analysis, we develop a clear strategy that holds meaningful outcomes at the fore. We then carefully guide your product’s success at every stage of
the journey - from initiation of human studies, through to final market authorisation
and beyond.

What we offer

The Accelagen difference

Accelagen’s work is underpinned by our unique reverse journey mapping approach. We build a comprehensive picture of the end goal that aims to define your ambitions and key milestones, with a focus on what the product would look like on the shelf. From there, we work backwards to map the
steps to achieve market approval, eliminating re- submissions and delays
to approvals.

Through expert consultation and analysis, we develop a clear strategy that holds meaningful outcomes at the fore. We then carefully guide your product’s success at every stage of
the journey - from initiation of human studies, through to final market authorisation
and beyond.

Our lasting partnerships

Providing accelerated and
globally-recognised pathways to market

Lasting partnerships

True collaboration that is built on knowledge sharing and transparency. We prioritise understanding our partners’ end goal, opportunities and challenges, and deliver success through our unique reverse journey mapping approach.

Meaningful results

Our work centres on achieving meaningful outcomes for human health. Through the delivery of 100+ clinical trials across multiple countries and successfully gaining regulatory approval for new and exciting therapeutic options for patients, Accelagen’s reputation is built on our success rate and quality data.

Adaptable processes

Drawing on proven processes, we work with partners to personalise their success strategy. We focus on getting the right answers quickly to keep projects moving forward.

Our values

Our core values guide everything we do and shape how we work with our partners to create meaningful outcomes.

Success the right way

We lead with positivity,
authenticity and a partnership
focused approach to create
sustainable growth for our
business and customers.

Thrive together

We are together on the journey.
We are at our best when working
together and seek relationships
that strengthen our collective
abilities.

Make a difference everyday

We make an impact in whatever way we can. We strive to make a genuine difference every day, no matter the scale.

Find better ways

We are experts who improve and innovate. We deliver exceptional outcomes through living our values and being the best we can be.

Our capabilities

Clinical development

Clinical services that deliver meaningful outcomes

Accelagen delivers success across all stages of development, from the transition from preclinical to First in Human evaluation, through to Phase IV studies, and for large to small scale trial sizes. Our world-leading clinical development team customises trial designs to fulfil strategic objectives and achieve rapid progress.

We offer a large range of clinical services to deliver meaningful outcomes for the future of human health

Our capabilities

Regulatory affairs

Gain efficient regulatory approval to bring your treatment of patients

We create effective pathways to product approval and future-proof plans for lifecycle management. Accelagen delivers holistic regulatory affairs strategies that span across regions, including the Asia-Pacific, North America
and Europe.

Our expert team uncover the pathways that maximise the likelihood of regulatory approval, with a focus on patient safety and risk mitigation.

Proven expertise

Leading the way

339

Device Approvals

57

Category 1 Applications

21

ODD Submissions

19

TGA Meetings

57

IND/IDE Submissions

59

CTN Submissions

132

Clinical Trial Sites

Testimonials

Trusted by partners worldwide

Accelagen Pty Ltd has been instrumental in guiding our project from development through to clinical trial commencement. Their support, particularly in navigating the complex documentation requirements including a meticulous review and input on our clinical protocol has been invaluable. The project’s success is managed masterfully under the leadership of Project Manager. We have also benefited immensely from working closely with their specialised data management and statistical teams from the outset. This collaboration has allowed us to define our data capture strategy and ensure we best understand how to interpret our results at the end of the trial. Beyond their technical expertise, the entire Accelagen team is remarkably friendly, helpful, and consistently approachable. Their proactive communication style, including some valuable regulatory advice along the way, and advance notice of any foreseeable changes in scope, has transformed what is, in reality, a highly complex trial into a reachable reality. With the aim of ‘First Patient In’ in early 2026, this trial will be a game-changer, and Accelagen has truly made this crucial milestone possible.

Dr Andrew Rayfield, PhD
Research Fellow, Research Commercialisation Manager

,

Clem Jones Centre for Neurobiology and Stem Cell Research, Griffith University

,

As a small biotechnology company, we rely heavily on our CROs partners to provide expertise and support across the full scope of services required to conduct a successful clinical study from start up to close out. I have worked with the Accelagen team for nearly 3 years now on two separate, complex clinical studies conducted at multiple Australian sites. With each new challenge, I have found the team to be supportive, responsive, flexible and professional. I have no hesitation in recommending them as a CRO.

Claudia Gregorio-King B.Sc., PhD
VP – Clinical Development

,

Kiora Pharmaceuticals

,

We have been working with Accelagen since March 2024 on a FIH study in Australia. We have been so impressed with their professionalism and service delivery that we decided to change CROs mid-way though our Phase IIa proof of concept study in the US. They are now they are that for us as well! Having worked for, and worked with various CROs, I rate Accelagen highly and wouldn’t hesitate to recommend them as a great option to running your study.

Katrina Pirlo
Human Clinical Project Manager

,

QBiotics Group

,

Working with the Accelagen team has been a very positive experience for us. The team is hands-on and sensitive to our needs. As a virtual biopharmaceutical company, having a partner like Accelagen that treats us with the same priority as a larger client makes an important difference in the success of our clinical trial programs in Australia.

Gary Pekoe
Chief Scientific Officer

,

Alphyn Biologics Inc

,

Support and guidance every step of the way. At the time we engaged with Accelagen as our Contract Research Organisation, we were unsure how to maximise the outcomes from our development program. Fortunately their team was able to support and guide us in setting a path to achieve our company goals.

Glenn Gilbert

,

Rhythm Biosciences

,

Working with Accelagen was instrumental in helping us create a clear pathway to marketing approval. I can't thank the team enough for steering us through the process and helping us all the way to a successful outcome!

Robert Klupacs

,

Bionics Institute

,

We approached Accelagen as we needed additional resources to complete our project. As a result of their assistance and advice, we were able to complete the necessary tasks required to achieve a successful marketing approval.

Jeremy Paull

,

Starpharma

,

Experience the Accelagen difference and unlock the future of human health