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Acquaint yourself with running early-phase clinical trials in Australia

Acquaint yourself with running early-phase clinical trials in Australia | Datapharm Australia | Scoop.it

If you would like to run Phase I and II studies, there is no better place to do it than in Australia. Nearly 30% of research studies conducted in Australia are early phase clinical trials. It is no surprise, as an unification of efficient regulatory framework, quick timelines, economical benefits, and a varied, dense population ensures Australia is globally competitive when operating early phase clinical trials. We also have a number of excellent, professional Phase I units which will be discussed in the second section of this article. Keep reading, and you will be able to make a more educated choice about where to run your next medical trial.

A Phase I (or first-in-humans) medical trial, is vital to developing all types of therapeutic interventions, including medications, procedures, and devices. It will be the first time that a treatment has been evaluated in humans, and therefore requires very close surveillance, care, and specialist equipment. The individual must be kept healthy, and any side effects must be minimized. Australia's medicine industry collectively commits over 1 billion dollars annually into R&D. Phase I alone is conservatively estimated to acquire 50 million in financial investments. When combined with the federal government's expenditure by means of the 43.5% R&D cashback to eligible companies, Australia spends a lot to guarantee that their research environment is first-rate.

If you wish to establish a medical trial in Australia, you should understand that the only ethics review you have to do is with a private committee. Notifying the administrative bodies in Australia is fast and simple via an online document, and you can sometimes receive notification back from them in just a week! There is also no need to provide an investigational new drug application (or equivalent) in Australia for Phase 1 experimental drugs. As these medications are produced in small amounts, a GMP license is not needed to manufacture them. Schedule 7 therapeutic goods are excluded from part 3-3 of the GCP Act. No wonder then, that businesses from around the world are flocking to Australia to run their early-phase research!

As Phase I is one of the most important moments in a medication's life cycle, it needs to be performed to the highest possible standards, and with the best equipment and staff. If you know what your specific requirements are, you will have the ability to better select the ideal investigator site to run your study. Australia has approximately 200 beds throughout its capital cities which are specialised for Phase I research. Q-Pharm in Brisbane, Queensland, has carried out over 400 trials and has 38 beds readily available for the thorough services they provide. CMAX in Adelaide, South Australia, is among the biggest and most knowledgeable early phase investigator sites, having 50 beds, a 15,000-strong volunteer data bank and expert staff. Nucleus Network is in Melbourne, Victoria, and is the largest Phase I clinical unit, having 80 beds, conducting 50 studies each year, and having an in-house pharmacy for drug compounding.

Linear, situated in Perth, Western Australia, is a 32 bed state-of-the-art center that excels in both patient and healthy volunteer research, completing over 150 trials in just 6 years, including 38 cancer studies. Scientia is an up-and-coming establishment, that plans to have 30 inpatient beds with cardiac telemetry, 18 consultation rooms, and 2 procedure rooms. While not strictly a Phase I unit by itself, Cancer Trials Australia is the largest network of Phase I cancer specialist units in Australia, and collectively have run over 1000 oncology clinical trials. So with all these elite facilities and outstanding government initiatives, Australia is extremely inviting for both local and international sponsors for running clinical trials. Get in touch now if you would like to know more, or need help expanding your trial to Australia.

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Australia's Generous 43.5% Medical Trial Tax Benefit

Australia's Generous 43.5% Medical Trial Tax Benefit | Datapharm Australia | Scoop.it
No matter if you are an overseas or Australian company, Australia is a great location to carry out research. Australia is supplying a 43.5% tax cashback when it comes to eligible research and development activities which meet particular criteria. Australia is providing among one of the largest cashbacks in the world, particularly compared with The U.S.A., which might take you even further when you take into consideration the currency exchange rate between the American and Australian dollar. Listed here are the primary company and activity criteria that you need to fulfil in order to be eligible.

Sponsors wishing to benefit from the cashback will more than likely satisfy the requirements if they are performing a Phase I, II, or III medical trial, however even Phase IV trials can fulfil this criteria! Only research carried out in Australia is eligible, whether that study is exclusively located in Australia or as part of a multicenter study. Your company must not produce more than twenty million Australia dollars in total to become eligible. Smaller cashback percentages are accessible for companies that exceed the twenty million. In any case, your refund will be based upon the amount of money you have invested in research in Australia.

Sponsors must also have legal entity in Australia, as this is who the money will be provided to. It is extremely easy to set up a subsidiary company within Australia, often it can be done within 48 hours. You may instead elect to have an Australian Contract Research Organisation (CRO) to act as your legal entity, but this may take longer to set up and, of course, you have limited control over the CRO than you do over your own subsidiary company. Working with a CRO when managing your trial in Australia is a smart idea despite the fact that they won't be functioning as your legal entity. This is due to the fact that they can help you navigate Australian law, and the prerequisites for doing research in Australia. Always make certain your chosen CRO is a registered Research Service Provider with AusIndustry, as this ensures they satisfy the government's requirements.

In terms of what R&D activities are allowed for the tax credit, they must be either a core or supportive activity. A core activity is an investigation that aims to produce new understanding about the therapy you are researching, and the reason the trial is being done is that the insight could not be secured otherwise. The trial needs to be derived from a scientific process, and begin with a theory based upon previous data, and after that proceed all the way to information analysis and conclusions. A supportive R&D activity is one that assists the core activity (which again must fulfil the requirements), but is not considered a core activity per se (like drug production).

Make sure you plan in advance if you wish to take advantage of the tax credit! In addition to these criteria, you must submit your claim around June 30, the end of the Australian fiscal year. It may likewise take 3 months after this point for you to receive the money from the government. If you are wishing to know more about the tax benefit and the circumstances surrounding it, get in touch with an Australian tax specialist or CRO today!

Disclaimer: The guidance given here is general in nature only, and is not aimed to be legal advice. Before acting upon this information, get expert advice specific to your current situation.
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The Clinitiative: A New, Community-Centered Approach to Clinical Trial Promotion

The Clinitiative: A New, Community-Centered Approach to Clinical Trial Promotion | Datapharm Australia | Scoop.it
The development of AustralianClinicalTrials.com is the culmination of Datapharm Australia's holistic approach to clinical trials. A fusion of community building, social media, and online interaction drives both the design and purpose of the website. Simply put, this is the next logical step in Datapharm Australia's mission to provide quality assistance and the best value at every step of the clinical trial process. With the launch of Australian Clinical Trials, both your needs and the needs of the clinical trial community can be better addressed.
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The real benefits of clinical research throughout Australia

The real benefits of clinical research throughout Australia | Datapharm Australia | Scoop.it

Australia has turned into one of the best places for running clinical trial research. A fantastic research environment, tax benefits, and an effective approval process are only a few of the reasons why you should think about extending your trials to Australia. Continue reading to uncover more about why Australia is rapidly becoming the preferred country for research

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FX-rates reduce Australian #clinicaltrial costs

FX-rates reduce Australian #clinicaltrial costs | Datapharm Australia | Scoop.it
The cost of having clinical trial work done in Australia has moved down dramatically recently and likely to stay down while the China demand for mined raw materials remains low and the Australian economy adjusts to the changes……. USD ~$0.80 buys AUD $1.00.
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What #Surfing Can Teach You About #Entrepreneurship @Datapharm

What #Surfing Can Teach You About #Entrepreneurship @Datapharm | Datapharm Australia | Scoop.it
In fact, surfing can teach you a lot about entrepreneurship.
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Prototype your social media marketing material quickly and automatically

Prototype your social media marketing material quickly and automatically | Datapharm Australia | Scoop.it
If you are organizing a clinical trial, it is necessary to prepare your promotional strategy. There are many methods of advertising, and you ought to consider which method would perform best for your research. As an example, there are many advantages to promoting online with Facebook, Twitter, Instagram, or Google. You can get to an exceptionally large number of individuals in a small amount of time, which is essential when trying to reach recruitment targets. Exposure is elevated, as the majority of websites will only have 1 or 2 advertisements on a page. In addition, you can take advantage of filters to ensure your ads display exclusively to those people who fit your study's requirements (such as age, gender, and geographic location), which in turn means your advertisement will be economical and focused. Moreover, online advertising is versatile, and can adapt to fit your requirements: in the event that your site is at capacity or if targets have been reached, you can pause your ad campaign. If circumstances change again later, you can reactivate your campaign with different criteria. Nevertheless, there are important details to think about when advertising online. Ethics submissions can be a slow and difficult experience, particularly when you consider that social media platforms show the same ads in several ways. This means that you must provide every variation of your ad to ethics, and it can be difficult to determine just what these variants are. Even when you learn the layouts, rapidly revising a picture or sentence across all your ads may be be time consuming. Social media also comes with some restrictions, including text and image limits. This is the reason why it is good to get a landing page for your trial the advert will redirect individuals to. To solve these concerns, AustralianClinicalTrials.com has put together a template generation tool, which you are able to use for free. Using this tool, you can now quickly and accurately produce social media advertising prototypes without having to mess about with an image editor. The tool will likewise preview what your clinical trial's landing page will look like. To get started, simply sign up to AustralianClinicalTrials.com here, log in after confirming, and press "Create an Advert" below the My Advert Templates heading. All you have to do now is fill in each field with the appropriate text or drop-down selection, and upload your primary and secondary images. Press submit, and immediately after you return to your account section, you can preview your social media ads and landing webpage. These can also be edited any time. When you are happy with your designs and are ready to show them to your colleagues or to ethics, download the page as an image, employing any full webpage capture add-on from the Firefox or Chrome web stores. Include that image when you send everything to ethics and you can be sure you are presenting your advertisements to them accurately and transparently. If you need any help using the template generator or even getting your ads on social media to speed recruitment, get in touch with us here!
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Advantages of participating in local clinical trials and ways to locate them

Advantages of participating in local clinical trials and ways to locate them | Datapharm Australia | Scoop.it
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The essential details for your clinical trial promotion

The essential details for your clinical trial promotion | Datapharm Australia | Scoop.it
When developing an ideal advertising campaign, it is helpful to keep things short and pertinent. This improves engagement, as viewers do not get bored or put off trying to wade through a wall of text. The target of an advert is to deliver a clear message, and recruiting for clinical trials is no different.
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8 INSIGHTS FOR A SUCCESSFUL CLINICAL TRIAL PROMOTION – PART 1

8 INSIGHTS FOR A SUCCESSFUL CLINICAL TRIAL PROMOTION – PART 1 | Datapharm Australia | Scoop.it
Basic and efficient advertisement for your clinical trial The methods you use to market a clinical trial directly affects how effective your overall trial will be. Without promotion, no-one will realise you have a trial running! But without efficient and informative advertising, the individuals who view your ad may not sign up. How you market also affects the stress that is placed on sites, as they may need to advertise to fulfil the study quota. This could induce them to spread their resources and time too thinly.
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Original Australian CRO founder Dr Helen Allars interview re Datapharm history...

In 2012, when we celebrated Datapharm’s 25th anniversary, I was asked how Datapharm started, as in 1987 the "CRO industry" was only just emerging and what change have we seen over that time...
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10 reasons to love Australia for Phase I #ClinicalTrials @Datapharm

10 reasons to love Australia for Phase I #ClinicalTrials @Datapharm | Datapharm Australia | Scoop.it
If you are looking to run a phase one clinical trial in the near future, you should consider the benefits Australia’s clinical research environment has to offer.
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