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Excellence, efficiency and quality in early phase, bioavailability and vaccine clinical studies

Q-Pharm Pty Limited is a specialised contract research organisation which undertakes a broad range of early phase (Phase 1 and Phase 2) clinical trials for clients in the global pharmaceutical and biotechnology industries.

The Benefits of Conducting Clinical Trials in Australia

In a recent benchmarking study* Australia was recognised as an ideal and safe location for Pharma Outsourcing. Conducting clinical trials in Australia has the following benefits:

  • Established and mature regulatory regime (an original contributing country to ICH-GCP guidelines)

  • Clinical Trials recognized as some of the best in the Asia Pacific region

  • High level of IP protection

  • Low risk destination (Infrastructure, Legal, Economic, Human Capital, Geopolitical)

  • Mature pharmaceutical market

  • Counter-seasonality with the Northern Hemisphere means trial sites can be initiated up to six months earlier for appropriate studies.

 * Source: The Changing Dynamics of pharma outsourcing in Asia: are you readjusting your sights? PWC 2008
 

Why Q-Pharm is the smart choice for Conducting Clinical Trials

Save TIME

  • Fast clinical trial start-up (~4-6 weeks from ethics submission to commencement of the clinical trial)

  • Frequent dates for ethics submission (40 meetings per year total - local & commercial committee options,)

  • Local HREC/IRB: Fixed timelines; In round/live review; Expedited approvals possible; ~10 meetings/yr

  • Commercial HREC/IRB: 3 submission dates / month (~30 meetings per year); Very rapid turn-around.

Save COSTS

  • Time is money – our clinical trials are completed on time and within budget

  • Low average cost (very cost competitive compared to U.S. and Western Europe)

COMFORT in working with an established provider

  • Excellent working relationship with local HREC (submitted, managed and conducted > 300 studies) and commercial HREC (multiple submissions approved in single round of review)

  • USA (FDA), Europe (AFSSAPS and AEMPS), and South America (ANVISA) inspected

  • Data accepted worldwide by regulators

  • Safe location (high level of IP protection, low-risk stable destination)

 

  

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