Clinical Research Training Courses

Clinical Quality Management Systems

Live online
Focused

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

Clinical Research - A Different Approach to Successful Project Delivery

New for 2023

Live online

Project management is not standing still, new ideas and ways of looking at project delivery are constantly changing. This workshop is designed to help you think differently about clinical research projects. Some of the concepts like System Thinking, the Theory of Constraints and Agile Project Management are not new but are often untried in our heavily regulated environment. Other techniques like Relational Risk and Complexity are very much at the forefront of current research. This course will provide you with key techniques to apply during your clinical research project to aid successful delivery.

Clinical Trial Monitoring

New for 2023

Live online

This course will assure monitors understand the importance of compliance with GCP standards, and how these apply to monitoring clinical trials including during the pandemic and in the future.

Data Integrity and Document Management

Live online
Focused

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.

EU Clinical Trial Regulation 536/2014: Overview and Implementation

Live online
Focused

This course will provide an essential understanding and update from Go Live from 2022 to help with compliance with the new regulation and associated implementing texts for carrying out clinical trials in the EU

GCP and Clinical Research Update - Hot Inspection Topics

Live online
Focused

This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments

Managing Vendor/CRO/CMO Oversight

Live online
Focused

Optimising oversight for inspection compliance

Medical Device Studies: Clinical Evidence

Live online
Focused

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

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

Live online
Focused

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

Metrics and Earned Value in Clinical Research Projects

New for 2023

Live online
Masterclass

The above quotation from Michael Hammer is as valid today as it was when he first said it. This workshop will focus on the effective use of metrics to monitor the real progress of your clinical research project. The session will look at deliverables and the important part that they play in the calculation of the Earned Value (EV), which is the ultimate leading metric and key performance indicator (KPI) for project progress. A valuable master class for anyone involved in clinical research.

Update - Latest Position on the New UK Clinical Trial Proposals

New for 2023

Live online
High impact

‘Better regulation…for better trials…for better health’ The Medicines and Healthcare products Regulatory Agency (MHRA) have set far-reaching proposals to improve and strengthen the UK clinical trials legislation to make the UK the best place to research and develop safe and innovative medicines. This webinar will bring you up-to-date with the current position regarding the proposals and the potential implications and opportunities for the industry.