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Research Training

GCP, Guidelines and Regulations

Are you new to clinical trials? Do you want to gain a broad overview of the most vital issues in research, the guidelines available and regulations to adhere to? You’ll learn about EU regulations, good practices in manufacturing, trial conduct and approval processes within the MHRA and HRA. You will also get a chance to learn about MHRA inspections and how to prepare for them. 

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Courses available:

  • Introduction to Good Clinical Practice (GCP)

  • EU directives in clinical trials

  • EU regulation update (Reg. 536/2014)

  • Good manufacturing practice & IMPs

  • MHRA inspections

  • Introduction to Investigational medicinal products (IMPs)

Clinical Trials Methodology

Are you involved in designing protocols and other aspects of clinical trials? Do you want to learn about essential documents required in research? You will learn about general introductions to clinical trials, how to set them up, project management and how ethics and consent plays a role in clinical research.

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Courses available:

  • Introduction to clinical trials

  • Phase I clinical trials

  • Clinical trial designs

  • Study set up

  • Trial Master File and essential documents

  • Ethics & consent in clinical research

  • Introduction to Medical Devices

Clinical Trial Conduct

Are you interested in learning about drug development in clinical trials? Do you want to gather more background learning on other types of trials such as advanced therapy trials, devices and biosimilars. You will learn how to risk base monitor, drug development and how to prepare for inspections. 

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Courses available:

  • Drug development process

  • Biosimilars in clinical research

  • Preparing for inspections & audits

  • Introduction to risk based monitoring

  • Monitoring for non-commercial trials

  • Advanced Therapy Trials

Get in touch for any specific training needs, or if you require on-site training for your team!

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