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The Clinical Trial Administrator (CTA) Tool Kit

This course provides an overview of the pharmaceutical industry, drug development process and clinical trial regulations - specifically for clinical trial administrators and other pharmaceutical administrators. What Is The Course About? This course is of interest to CTAs and other pharmaceutical administrators who need a better understanding of the drug development and clinical trials processes and how they can support it. By the end of this course, you will be able to: • Understand clinical trial terminology • Understand the clinical trials process and its key stages • Understand how different organisations interact and the roles of the different departments • Understand the controls and regulations in the industry • Understand the role of Ethics Committees • Understand the importance of Trial Master Files and Standard Operating Procedures • Understand the importance of patient protection in research • Understand the audit/inspection process • Understand the controls and restraints of promoting products Language • What does it all mean? Overview of the Pharmaceutical Industry • Important therapeutic areas • Who does what in a pharmaceutical industry • Outsourcing Drug Research & Development • Patents • How are drugs discovered? • Drug screening Clinical Research • Stages of clinical research including pre-clinical and Phase I-IV clinical trials Important Aspects of Clinical Research • Critical path of a clinical trial • Patient protection and the role of Ethics Committees • Trial Master Files and Site Files • Preparing for audits and inspections • Standard Operating Procedures Marketing & Sales • How are drugs marketed and sold • Controls and constraints • Pharmaceutical markets

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About Us

Since 1987, we have been delivering quality training to the pharmaceutical, healthcare, CRO and related industries. As well as delivering technical courses supporting clinical research functions, we also offer a wide range of personal development courses to ensure that skills learnt can be applied in the workplace.

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Rostrum Training Solutions Ltd

24 Lansdowne Road
RG30 4QU

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