Armstrong Clinical has now completed its first 2 years of operations. Although these two year have been during challenging time, our first years providing strategic advice to companies looking to develop new therapies has been very positive and I am happy to share some metrics describing our first two years. During this time, 21 clients,…
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Overcoming the Challenges Through Effective Clinical Study Design When developing novel therapies targeting rare diseases, a departure from classical development strategies is often required. Still, the quality of evidence generated to prove effectiveness of a new orphan disease therapy is no different to the quality expected of new therapies targeting common diseases. Marketing authorisation submission for…
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We sit down with Haplomind founder Dr. Sonali Mohanty Quantius to understand more about Haplomind and its use in the treatment of Post-Partum Mental Health Data analytics and machine learning continue to play a larger role in health care, drug discovery and treatment optimisation. Dr. Sonali Mohanty Quantius, a former global pharmaceutical executive, current founder of Haplomind,…
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Bradley Joblin from Armstrong Clinical has been invited to be the guest speaker at the AGM of HSP Research Foundation. Hereditary Spastic Paraplegia (HSP) is a rare degenerative neurological disorder without any current treatment options. Through innovative stem cell technologies, the HSP research team, including Australian of the Year Prof. Alan Mackay-Sim, has discovered a…
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Melbourne (Australia) – 4th August 2020: Armstrong Clinical, specialists in clinical development strategy, early phase clinical study design, pricing and regulatory strategy is pleased to announce it has entered into an agreement for collaborative services with My Medical Department, an independent late phase drug development and commercialisation consultancy. The agreement enables Armstrong Clinical clients to access the…
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The aim for many biotech companies taking a discovery into clinical development will be to generate data from phase 1 studies, not only to understand the potential of their discovery but often also to attract further investment or a potential licensing deal. However, one of the keys for the successful commercialization of any therapy is…
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Important goals of pre-clinical drug development programs (in silico, in vivo, in vitro studies) include the formulation of precise estimates correlating preclinical results to clinical outcomes and to make sure sufficient data has been generated for a new therapy to enter first in human clinical studies. Information generated pre-clinically will also frame the first in…
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The Australian Commission on Safety and Quality in Health Care (ACSQHC or the Commission) is working with the Australian Government Department of Health on behalf of all jurisdictions to create the National Clinical Trials Governance (the Governance Framework) as a first step towards a nationally uniform accreditation approach for health services conducting clinical trials.
The Australian clinical trial industry is large and growing fast. Roughly 1,360 new clinical trials were conducted in Australia in 2015, and since 2010, this number has grown at approximately 5 percent per year. In this post we will point out some key points about conducting Clinical Trials in Australia.
