Our advanced scientific infrastructure and world-class experts attract trials from across the globe and meet their needs with the highest standards and efficient regulatory requirements.

Explore the extensive benefits of Australia’s clinical research ecosystem below.

1. GLOBALLY ACCEPTED DATA
   Alliance Pharma has a world-class reputation for quality data, following the highest level of GCP and ICH standards. Data from clinical trials conducted in Australia is widely accepted by all regulatory authorities including FDA and EMA.
   
   
2. EXTEND YOUR BUDGET BY 43.5%
    includes bioanalytics services
    almost halve your clinical trial costs
   
   You can claim R&D cash refund with the Australian Government clinical trial rebate program. As an example, if you spend $200k on eligible R&D, you can receive $87k (43.5%) back from the Australian Tax Office (ATO). This effectively means you could turn $1million dollars into $1.7 million dollars of research spend in just three years.
   
   
3. RAPID START-UP & APPROVAL
    The Australian Regulatory Framework is the fastest in the world for undertaking early phase clinical research trials
    Trials can start in 4-8 weeks compared to 10 months in the US.
    No IND required for clinical trials. Save up to a year in regulatory timelines and considerable costs.
   
   
4. INDUSTRY-LEADING TECHNOLOGY
   Clinical trials are resource-intensive processes requiring the availability of state-of-the-art equipment and facilities for testing and analysis. We have invested heavily in the industry-leading technology platforms to support speed, communications, and regulatory compliance.
   
   
5. GLOBAL CAPABILITIES
   Local relationships, global execution As a global contract research organization – with sites in USA and UK – we can provide internal assay transfer and validation protocols among our global sites.
   
   Harmonized SOPs, policies, and IT systems to facilitate transfer of methods, data, and information enable you to reduce time, risk, and cost.
   
   
6. SEASONAL DIFFERENCES
   Seasonal differences to Europe and US, and time differences (our Australia lab works while you sleep)Seasonal differences between Australia and Europe or the US allow for yearlong participant recruitment for trials involving seasonal illnesses such as flu or allergies and allows researchers to cover seasonal variations in patient recruitment.
   
   
7. HEALTHCARE ENVIRONMENT
   Australian clinical practices and some aspects of its health care system are similar to the United States, United Kingdom and most of Europe.
   
   
8. DIVERSE PARTICIPANT RECRUITMENT
   The willingness of potential participants and their knowledge of clinical trials is another attractive option for sponsors to conduct trials in Australia.
   
   A mixed population of Caucasians and Asian adds diversity to the participant pool and enables ethnicity differences in treatment response to be studied.
   
   

Need Support to Conduct Clinical Trials in Australia?  Contact Alliance!

As a CRO, meeting client expectations can be an ongoing challenge. What can organisations do to make sure their research is as effective and efficient as possible?

In the Autumn 2022 issue of European Pharmaceutical Contractor magazine, the leadership team from Alliance Pharma reviews what CRO organisations can do to make sure their research is as effective and efficient as possible while meeting the ongoing challenge of their customer's expectations.

Patrick Bennett, Jean Pierre Boutrand, and Vito Saccente at Alliance Pharma

Serving clients is the core of a contract research organisation’s (CRO) business. The more comprehensive a CRO’s service offerings, the more likely it is to attract and retain clients. Recent events – like the COVID-19 pandemic – have set in motion industry shifts. Such shifts demand CROs adapt so that they can continue meeting their clients’ evolving needs . . .

READ MORE

Chunying Gao, Ph.D.

Drug transporters play a key role in the absorption, distribution, metabolism, elimination and toxicity (ADME-Tox) of many drugs by controlling the entry or exit of drug molecules into and out of tissues or organs. Due to the importance of drug transporters in these processes and the potential drug-drug interactions among drug molecules on these transporters, in vitro transport studies on a standard panel of drug transporters are recommended by the FDA, EMA, and PDMA regulatory agencies to evaluate the potential interactions as substrates and/or inhibitors among the investigational drugs. The current panel includes P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, OCT2, MATE1 and MATE2-K; although regulatory agencies are routinely requesting data on additional transporters outside of the current group. 

According to the FDA guidance,^[1] several in vitro models are recommended for each transporter:

Alliance Pharma has established a set of cell- or membrane vesicle-based assays to support filing packages for the studies recommended by regulatory agencies. For ABC transporters, a membrane vesicle assay (for P-gp and BCRP) and MDR1/MDCK bidirectional permeability assay (for P-gp) has been established. For SLC transporters, an assay platform based on transiently transfected HEK293 cells has been optimized and validated, and can be used for both screening of substrate/inhibitor and K_m/IC₅₀ determination.

[1] https://www.fda.gov/downloads/Drugs/Guidances/UCM581965.pdf