Clinical Research Training Courses

This brand new course on the recently published and long-awaited ICH GCP E6 (R3) is designed to help participants stay compliant and implement the new guideline effectively.

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and a brief review of key FDA requirements.

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

A two-day course that will ensure you comply with new regulatory requirements.

This one-day course will provide a clear understanding of the clinical evaluation requirements and their practical application for software products, including AI/ML-based devices.

This course will help delegates gain a better understanding of the software automation technology driving change within the clinical trials landscape.

This Clinical Research Project Management Training course will provide you with key techniques to apply during your clinical research project to aid successful project delivery. This course will be key for those involved in clinical research projects and will cover system thinking, agile approaches and risk analysis.

This essential course will explain the importance of using risk management techniques in clinical trials to comply with the latest focus on inspection in this area.

This course will provide an update on the experience of working to the regulation since Go-live, to help your implementation and compliance including transferring clinical trials from the directive to the regulation.

Explore the microbiome and its high clinical relevance, as well as learning about the different methodology used in microbiomic clinical trials.

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR.

In this course, you will see the value of remote patient adherence monitoring and learn how to stay ahead of the curve by creating your own digital solutions. 

Optimising oversight for inspection compliance.

The leading clinical research project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health

Learn how to build digital technology that is specifically aligned to match with the patient, the clinical study, the disease and the treatment programme.

AI and Machine Learning are revolutionising clinical trial data management by enhancing efficiency, streamlining processes, and minimising human error. This course will be of use in both the pharmaceutical and medical device industry.

A deep dive into the importance of real world evidence (RWE), real world data (RWD) and artificial intelligence (AI) in pharmaceuticals.

This course provides the latest updates on the finalised ICH GCP E6 R3 guideline, EU Clinical Trial Regulation update, other EU and FDA requirements, consideration for managing studies in the future and AI and other technology developments.

This workshop will focus on the effective use of metrics to monitor the real progress of your clinical research project. A valuable master class for anyone involved in clinical research.

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.