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Health and Aged Care

Scientia Clinical Research

Scientia Clinical Research (SCR) is a FDA audited, not-for-profit early phase clinical trial company, operating a 30-bed, phase I unit, co-located within the Prince of Wales Hospital.

SCR conducts approximately 40 clinical trials per year, the majority being First Time In Human (FTIH) single and multiple dose studies, food effect studies, drug interaction studies, ethnopharmacology studies, biosimilar studies, formulation studies and specialty studies.

The majority of our sponsors are multinational pharmaceutical and biotechnology companies.

Australia has a fast & pragmatic clinical trial approval scheme.

SCR ethics review cycle is approximately 4-6 weeks from submission to approval, which allows first dosing to occur 6-8 weeks from submission to Ethics.

SCR can manufacture finished product (investigational product) from active pharmaceutical ingredients and manage investigational product importation, receipt and labelling. These services have provided significant time and cost savings to our Sponsors.

Scientia Clinical Research(SCR)是一家获得FDA认证的非盈利性早期临床试验公司,拥有30个床位的I期临床测试点,与威尔斯亲王医院同址。

SCR每年进行约40项临床试验,其中大多数是首次人体试验(FTIH)的单剂量和多剂量研究、食物效应研究、药物相互作用研究、民族药理学研究、生物类似物研究、制剂研究和专业研究。

我们的出资方大多是跨国制药和生物技术公司。

澳大利亚拥有快速务实的临床试验批准计划。

从提交到获批,SCR的伦理审查周期约为4-6周,因此伦理审查提交后6-8周内即可进行首次给药试验。

SCR能够使用活性药物成分制造成品(试验用药品),并管理试验用药品的进口、接收和标签。这些服务为我们的出资方显著节约了时间和成本。

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