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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> Three Essential Features of an ELISA That Every BioPharmaceutical Scientist Needs to Understand

Apr 26, 2019 11:00:00 AM / by Nathan Fritzinger posted in Pharmaceuticals, Immunoassay, laboratory

          An enzyme-linked immunosorbent assay (ELISA) is a chemical test to detect the presence of proteins or other molecules. The enzyme-labeled antibody binds to antigens leading to a color change that is used to quantify antigen-antibody interactions. Quantification of these concentrations requires measuring the intensity of the color change, which indicates the concentration of antigen bound to the antibody. ELISA’s include four variants: direct, indirect, sandwich, and competitive, which all have their respective advantages and disadvantages.

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Benefits of an ELISA

High Sensitivity: The concentration of both antibody and antigen can be quantified on the nanogram scale. This means that scientists can use a smaller amount of enzyme, which still produces a large scale catalytic reaction.

High Specificity: Antibodies are very specific to their targets due to their spatial configuration and chemical structure. They can easily recognize and bind to antigens similar to how a key unlocks a specific door.

Versatility: Indirect ELISA’s allow for multiple primary antibodies created in one species with the same labeled secondary antibody used for detection. Also, it’s easy to wash off any unbound antibodies by applying a detergent solution to the plate.

Clinically approved ELISA tests for diseases like HIV, Lyme disease, and tuberculosis are proving their efficacy and value to the Pharmaceutical industry.

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Meso Scale Discovery® (MSD) V-PLEX Aβ Peptide Panel

Nov 25, 2013 5:38:00 AM / by adminweb_1 posted in Immunoassay

Alliance Pharma has successfully completed testing and validation of the Meso Scale Discovery® (MSD) Human V-PLEX Aβ Peptide Panel 1 Assay (6E10).  With the completion of this validation, Alliance Pharma becomes the first global CRO to validate the Aβ V-PLEX Panel 1, and greatly expands its analytical capabilities in Alzheimer’s and Neurodegenerative Diseases.

The MSD Aβ V-PLEX Panel 1 (6E10) is a multiplexed sandwich immunoassay which measures three amyloid peptides of significance to Alzheimer’s disease: Aβ42, Aβ40, and Aβ38.  MSD neurodegenerative disease assays provide a sensitive method for measuring the levels of peptide and protein targets within a single, small-volume sample.  V-PLEX immunoassays are developed under rigorous design control and are fully validated according to “Fit for Purpose” principles.

Sensitive biomarker assays are proving crucial to the design and execution of clinical trials that target the earliest stages of Alzheimer’s disease.  The Aβ Peptide Panel 1 (6E10) kit is validated for human CSF and thus is ideally suited for this purpose.

“The addition of the Meso Scale Discovery® MSD Aβ V-PLEX immunoassay to our service portfolio will further help our sponsors in the development of drugs to treat neurodegenerative diseases” said Dr. Feng Li, President of Alliance Pharma.

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