NEWS: Our Blog

Australia Advantage – Consider Conducting Clinical Trials in Australia

Mar 16, 2023 11:33:42 AM / by Alliance Pharma posted in Pharmaceuticals, Immunoassay, bioanalytical, laboratory, Quality, Large Molecule, Bioanalysis, DMPK, Australia

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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!

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> Alliance Pharma Bioanalytical Team Adds New Instrumentation to Expand Large Molecule Bioanalysis Capability

Sep 21, 2018 4:41:17 PM / by Colin Barry, Ph.D. & Scott Ugrin, Ph.D. posted in Pharmaceuticals, bioanalytical, Large Molecule, Bioanalysis

Colin Barry, Ph.D. & Scott Ugrin, Ph.D.

Alliance Pharma’s bioanalytical team provides comprehensive services for both small and large molecules using a variety of platforms from mass spectrometry to ligand binding assays using an assortment of specialized instrumentation. Our analytical laboratories boast thirteen LC-MS/MS systems from three different manufacturers and include various platforms. Nine systems from AB Sciex are each coupled to Shimadzu UHPLC systems, including two API4000 QTRAP systems, two API4000 triple quad systems, three 5500 triple quad systems, and two 6500 triple quad systems. Each system is designed for high sensitivity quantitative analysis of small molecules generated from either in vitro or in vivo studies and in various matrices.

Alliance Pharma’s small molecule mass-spec based bioanalytical team specializes in:

  • Development, optimization, and transfer of bioanalytical assays
  • Method Validation
  • Sample analysis to support clinical (GLP) and non-clinical studies
  • Plasma, serum, whole blood, and all tissue types
  • Biomarker assay development, validation and sample analysis
  • High throughput screening from in vitro ADME assays
  • Metabolite identification

 

The newest additions to the bioanalytical lab include two Agilent 6545 XT Q-ToF high resolution mass spectrometers coupled to Agilent 1290 Infinity II UHPLC systems with PDA and FL detectors. These new systems add additional capacity to our existing high-resolution accurate-mass (HRAM) systems: 1) a Dionex RSLCnano, 2-D nano/micro/cap UHPLC system coupled to a Q Exactive Plus, and 2) an Orbitrap XL from Thermo Scientific. The newest HRAM systems are ideally suited for analysis of proteins and peptides and will allow generation of highly detailed information for intact proteins and antibodies, confirmation of sequence at the peptide level, and sophisticated analysis of both simple and comprehensive post-translational modifications.

The combination of mass accuracy (> 1 ppm) and high resolution (up to 280,000 at m/z 200) allow for increased specificity and sensitivity in extremely complex matrices. The additional capabilities position Alliance Pharma to continue to expand our large molecule qualitative and quantitative analysis capabilities.

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