The Australian CRO

With A Personalized Approach To Your Project

About Us

Alithia Life Sciences is an Australian owned boutique, full-service capability Contract Research Organization (CRO) launched to support and assist pharmaceutical, biotechnology, device companies and institutional research groups undertaking their project in the Australian region and beyond. 

We have an average of 25+ years of operational expertise and industry experience in various therapeutic areas including, first in human studies (FIH), devices, endocrinology, oncology, neurology, gastroenterology, rare and pediatric diseases and vaccines. 

Our breadth of expertise in the academic, commercial and biotechnology settings can support your project from Phase I through to Phase III. 

Our local and global experience includes developing products successfully through to FDA approval, executive management and previous establishment of a successful Contract Research Organization (CRO).

What We Do

  • Expertise in local and global studies of Phases I to III
  • Overall management of projects and clinical strategy on behalf of local and international Sponsors from concept to start up and through to close out.
  • Biotech executive management and director support provision (local directorship).
  • Clinical research suite: project and site management, site feasibility and selection, selection and management of vendors, monitoring support, trusted data management and biostatistical solutions, local and global medical monitor capabilities.
  • Identification and access to Key Opinion Leaders (KOLs).
  • Clinical and regulatory project planning and study design in accordance with international guidance documents.
  • Access to an extensive network of project enabling vendors including laboratories and R&D tax experts Investigational Product depots.

Our Vision And Mission

  • To work with our clients to deliver efficient accomplishment of their projects
  • Add value to their programs and,
  • To ultimately enable improvement of human health and wellbeing.

Testimonials

I met Tina almost 1 year ago at a networking event and immediately felt her knowledge and understanding of the clinical trial ecosystem. Since then, we have had the opportunity to work with Alithia on a major project for our company and meet and work closely with Mary.

Tina and Mary are focused on meeting client expectations, taking the time to understand the nature of the project and its complexities. With each new challenge, they help implement creative solutions while balancing our expectations and timelines. It has truly been a pleasure collaborating with this talented duo, and their contribution and commitment to our program has been crucial to the planning of our trial. We consider Alithia part of the Avecho clinical team and trust them at every stage of our clinical development.

Thank you again Tina and Mary!

Dr Roksan Libinaki

Chief Operating Officer
Avecho Biotechnology Limited

In the crowded area of professional service companies, where Regulatory Contract Research Organisations compete for business, Alithia Life Sciences, stands out amongst its peers both in terms of cost and performance. I have no hesitation in recommending Alithia as they have been a very reliable service provider for all stages of our clinical trial development programme.

Alithia is big enough to know the regulatory requirements but small enough to give you the A-team. In particular, we have used Alithia’s professional services in the following areas:

  • Ensuring compliance requirements are met with regulatory bodies as we navigate the demands and complexity of clinical trials
  • Planning and coordinating our clinical trial and troubleshooting where necessary
  • Advising of risk factors in our strategy and navigating around obstacles or challenges from our downstream providers
  • Liaising with providers for the timely manufacture and delivery of API and the downstream tabletting of our product
  • Introducing regulatory specialists where necessary to advise on navigating the complex regulatory pathways to optimise costs and progress.

Roger Aston

Chief Executive Officer
PharmAust

Contact Us

Talk to us about how we can support achievement of your project goals.

 Alithia Life Sciences: Overview | LinkedIn

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