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我们是谁

Accelagen是一家领先的全球合同研究组织(CRO)。我们的使命是共同创造有意义的成果,对人类健康的未来产生切实影响。

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.

我们提供什么

Accelagen 的区别

Accelagen的工作以我们独特的反向旅程测绘方法为基础。我们全面描述了最终目标,旨在定义您的抱负和关键里程碑,重点是产品在货架上的样子。从那里,我们向后工作来映射
获得市场批准的步骤,消除重新提交和延迟
以获得批准。

通过专家咨询和分析,我们制定了明确的战略,将有意义的成果放在首位。然后,我们会仔细指导您的产品在每个阶段取得成功
旅程——从开始人体研究,到最终的市场授权
及以后。

我们持久的合作伙伴关系

提供加速和
全球认可的市场途径

持久的伙伴关系

建立在知识共享和透明度基础上的真正协作。我们优先考虑了解合作伙伴的最终目标、机遇和挑战,并通过我们独特的逆向旅程规划方法取得成功。

有意义的结果

我们的工作重点是为人类健康取得有意义的成果。Accelagen通过在多个国家进行了100多项临床试验,并成功获得监管部门的批准,为患者提供新的令人兴奋的治疗方案,Accelagen的声誉建立在我们的成功率和质量数据之上。

适应性强的流程

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.

我们的能力

临床开发

提供有意义结果的临床服务

Accelagen在开发的各个阶段都取得了成功,从临床前评估过渡到首次人体评估,再到IV期研究,再到大到小规模的试验。我们世界领先的临床开发团队可定制试验设计,以实现战略目标并快速取得进展。

我们提供广泛的临床服务,为人类健康的未来提供有意义的结果

我们的能力

监管事务

获得有效的监管部门批准,为患者提供治疗

我们创建了有效的产品批准途径和面向未来的生命周期管理计划。Accelagen提供跨地区的整体监管事务战略,包括亚太地区、北美
和欧洲。

我们的专家团队发现了最大限度地提高监管部门批准可能性的途径,重点是患者安全和风险缓解。

经过验证的专业知识

引领潮流

339

设备认证

57

第 1 类应用程序

21

ODD 提交

19

TGA 会议

57

IND/IDE 提交的内容

59

CTN 提交的内容

132

临床试验地点

感言

受到全球合作伙伴的信赖

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

全程支持和指导。当我们作为合同研究组织与Accelagen合作时,我们不确定如何最大限度地提高开发计划的成果。幸运的是,他们的团队能够支持和指导我们设定实现公司目标的道路。

Glenn Gilbert


Rhythm Biosciences

与Accelagen合作在帮助我们开辟一条通往市场批准的明确途径方面发挥了重要作用。我对团队指导我们完成整个过程并一直帮助我们取得成功的结果都不为过!

Robert Klupacs


Bionics Institute

我们之所以联系Accelagen,是因为我们需要额外的资源来完成我们的项目。在他们的帮助和建议下,我们得以完成成功获得上市批准所需的必要任务。

Jeremy Paull


Starpharma

体验 Accelagen 的不同之处,开启人类健康的未来