![]() Malia’s vast range of expertise has developed from her roles and experience within start-up, clinical trial monitoring, clinical trial management, operations, clinical quality assurance, compliance, training and continuous improvement. ![]() Prior to this she held SCRA roles at Parexel and Quintiles (IQVIA). Malia has led a team of CRAs and Managers at Novotech for over 5 years and contributed to the implementation of new TMF structure, Clinical Operations SharePoint and enhancing relations with Australia’s Key Opinion Leaders and research Institutions. Malia Rogers, Operations Director NSW, Novotech, an Asia-Pacific Clinical Research Organisation is a clinical research professional with 16 years’ experience in healthcare and research across pharmaceutical and clinical research organisations. Identify systems and process to assist you during study start up, including TMF and document management Outline jurisdictional requirements in Australia for starting up a clinical trial in the different states and territories as well as any state-wide clinical trial initiatives Institution (SC, HREC Coordinator), Sponsor/CRO, HREC and Regulatory Authorities (TGA)īest Practices and case studies to assist understanding and application of effective and efficient start-up processes and strategiesīy the end of this course you will be able to:ĭescribe the study start-up process and the various stakeholders involved at the start up stage of the studyĭescribe the challenges experienced and possible strategies deployed during a typical study start-up process Roles and responsibilities of the various bodies involved in study start-up e.g. Understand the essential components of study start-upĬritical factors contributing towards an effective trial study start up Stream-lined and efficient study start-up is essential to the success of a study and to ensure Australia remains internationally competitive as a primary destination for clinical trials.Īnyone wanting to further develop their understanding and proficiency with clinical trial study start up including:Ĭommercial & non-commercial clinical trial sponsors Despite efforts to finish trials on time, as many of 45% of clinical trials are completed late and approximately 80% of trials fail to meet their initial enrolment targets on time.
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