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In this one day course we explore clinical investigations for medical devices.  We will review the latest legislation and its impact on determining whether a clinical trial is required.  Our experienced trainer will guide you through the key stages in designing and executing your clinical investigation.  Through practical exercises delegates will tackle common challenges and develop strategies to overcome them.

Statistics is the art and science of summarising data.  Statistics play an essential role in all stages of clinical research from design through to analysis and interpretation. 

Clinical Trials generate large volumes of data but most of us are looking for the “punch-line”;  Did the new treatment work?  Were the two groups being compared the same of different?  We rely on statistics to help us design the most appropriate trial to answer our questions, to determine the required sample size and to interpret the results.  A poorly designed study wastes time, resources and puts patients at unnecessary risk.  A solid understanding of statistical principals is important for all team members, not just the team statistician; however for many of us statistics is nearly a foreign language. 

This course is aimed at non-statisticians who work in clinical research and provides an introduction to the statistical methods used for the design, conduct and analysis of clinical trials.  The course emphasises the application of statistical concepts to clinical research; aiming to demystify the subject and equipping delegates with the knowledge to read, understand, interpret and communicate data & statistics. 

This is an introductory course and no significant mathematical knowledge is required.

Delegates should bring a laptop and calculator to the course.

This course provides an in-depth look at the regulatory systems currently in operation in the EU and their impact, together with UK legislation, on the conduct of clinical research. Starting with a refresher on the history of medicinal product regulations and the need for ethics, the course explains in more detail the practical applications of GCP and outlines recent major developments in GCP. It also explores the impact of EU data protection laws on clinical research and summarises other current issues that affect clinical trials. 

Delegates will receive a complimentary copy of the ICH GCP guidelines and a workbook

Are you a clinical researcher who has to review and approve data management plans, but find yourself struggling to know what you should be looking for?  Do you have to select a Data Management vendor but don’t know how to evaluate their capabilities?  In this course we will explore data management terminology, data management plans, coding and (e)CRFs so that you can work more effectively with data management specialists.

THIS COURSE DATE IS TO BE CONFIRMED                                  Please email office@icr-global.com for enquiries

This course provides an in-depth look at the regulatory systems currently in operation in the EU and their impact, together with UK legislation, on the conduct of clinical research. Starting with a refresher on the history of medicinal product regulations and the need for ethics, the course explains in more detail the practical applications of GCP and outlines recent major developments in GCP. It also explores the impact of EU data protection laws on clinical research and summarises other current issues that affect clinical trials.

Delegates will receive a complimentary copy of the ICH GCP guidelines and a workbook.

This course will run ONLINE VIA ZOOM

Medical Devices have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. There are over 300 000 types of medical devices on the EU market, examples of which include sticking plasters, contact lenses, X-ray machines, pacemakers, breast implants, software apps and hip replacements. The medical devices sector is essential to the provision of healthcare and is an important player in both the European and global economy.

Released in 2020 the updated ISO14155 standard, which addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices, has been significantly revised.

Approximately 1.5 million different medical devices are available globally; with thousands of new and innovative medical devices being introduced to the market every year. While there is legislation at the national and regional level ISO 14155 provides a global standard for clinical investigations on human subjects.

Please note: ISO 14155 is only applicable for Medical Devices including diagnostic/imaging devices BUT NOT In Vitro diagnostics (IVD).

DATE TBC

Vendor Oversight is currently a hot topic as sponsors and vendors aim to get to grips with what is really required.  You don’t want to outsource and then expend multiple resources to manage and oversee your trial.  As a vendor you want to get on with the outsourced clinical trial in the most effective way feasible without micromanagement from your sponsor company.   What is required to compliantly and efficiently implement vendor oversight? What are the risks and challenges of not getting this right from the beginning? This course will aim to work through some of these challenging topics with time given to work through specific scenarios from the attendees. 

This course provides an in-depth look at the regulatory systems currently in operation in the EU and their impact, together with UK legislation, on the conduct of clinical research. Starting with a refresher on the history of medicinal product regulations and the need for ethics, the course explains in more detail the practical applications of GCP and outlines recent major developments in GCP. It also explores the impact of EU data protection laws on clinical research and summarises other current issues that affect clinical trials. 

Delegates will receive a complimentary copy of the ICH GCP guidelines and a workbook