Training for Clinical Trial Staff
Improve the Skills of Your Clinical Trial Staff with Our Training Courses
Stridon provides quality and practical training on different aspects of clinical trials and the regulations governing their conduct. Our training programme is suitable for both commercial and non-commercial organisations involved in clinical research.
The training courses, delivered by highly experienced professionals, focus on providing good understanding of the lifecycle of a clinical trial, from design to reporting, and the key steps involved in its delivery. The training is based on practical and interactive content, dotted with real-world examples enabling trainees to learn concrete approaches that they can apply at their own organisations and to clinical studies they conduct. The whole learning experience is designed to build competence and improve job performance.
All of our courses are designed as one-day training sessions, delivered on-site at your organisation, giving you assurance of confidentiality when discussing specific issues and enabling us to deliver fully customised training according to your exact needs. This may involve using your working practices and
templates in the learning activities so that the course participants can easily relate theory with actual processes in your company or institution.
The courses are delivered in English or in the local language depending on the clients’ preferences and the country in which the training is provided. A Certificate of Completion is issued at the end of each course.
Stridon's Training Courses
Principles and Practice of Clinical Trials
The course provides a thorough grounding in the fundamentals of clinical trials, focusing on study design, setup, ethics, recruitment, conduct, analysis and reporting. It includes the theory behind as well as practical examples and guidance on the methodology of clinical trials using a problem-solving learning approach.
Clinical Trial Design and Protocol Writing
The aim of this course is to provide an understanding of key issues in the trial design and give detailed instructions on how to write an effective and regulatory compliant clinical trial protocol.
Source and Control of Bias in Clinical Trials
The course identifies the most common sources of bias in clinical research and then goes on to provide methodical solutions and detailed instructions on how to avoid biases in clinical trial design, conduct and analysis to ensuring accurate and scientifically sound outcomes.
Ethics and Regulation of Clinical Trials
This course reviews the key ethical principles and some common ethical challenges involved in the conduct of clinical trials. The course describes the evolution of ethical codes and regulations over time and it examines the ethical responsibilities of investigators and other clinical research staff in an interactive way. The course provides practical guidance on the content and preparation of clinical trial applications both to Ethics Committees/ Institutional Review Boards and to regulatory authorities.
Trial Master File Setup and Management
The course gives systematic and detailed instructions on the setup and maintenance of Trial Master File in full compliance with the latest regulatory guidelines. It also reviews the most effective ways for documentation management from the trial initiation to the close-out and archiving.
Effective Clinical Trial Management
Trainees on this course will learn how to set up and run successful trials to produce reliable results, on time and to budget, using best practice for the management and project delivery.
Essentials of Risk–Based Clinical Trial Monitoring
The course is designed as an introduction to risk–based monitoring with practical guidance on how to organise efficient monitoring at a clinical trial site without compromising patient safety or data quality.
Introduction to Clinical Study Report (CSR) Writing
Introduction to CSR writing course is designed for organisations who aspire to develop in-house resources for CSR writing or hone the skills of their existing medical writer(s). We will share our extensive medical writing experience and will train your staff in a systematic way on how to write a well-constructed and clear study report that meets the most stringent scientific and regulatory criteria.
Quality Management Systems for Clinical Trials
This course covers the requirements for an effective and regulatory compliant Quality Management System (QMS) in an organisation engaged in the conduct of clinical trials. The objective of the course is to train your team to develop and maintain a QMS which stands up to scrutiny during regulatory inspections and ensures reliable and scientifically sound trial outcomes.
Introduction and Refresher Courses on Good Clinical Practice (GCP)
Our GCP courses provide an up to date and comprehensive guide to the ICH Good Clinical Practice principles. The GCP Introduction course is designed for those who are new to clinical research and the Refresher course is for experienced research staff who have either previously completed an Introduction course or have recent practical experience of working in a clinical research environment and good understanding of the GCP essentials.
Preparing for Regulatory Inspection Training
This training course is designed for organisations sponsoring or hosting clinical trials to facilitate their preparations for future inspections by regulatory authorities. The training provides guidance and practical advice on how to prepare for an inspection and what to expect during the inspection. Our trainers will deliver practical advice on how to get your staff ready for compliance inspectors’ questions and run you through common inspection findings.
If you have a training need which is not listed above, we will be more than happy to develop bespoke training courses that will meet your specific training requirements.
As part of our service, we also offer a follow up with you on the effectiveness of the training, assessing how the newly acquired knowledge is applied in the work place and discussing next steps in the development of your staff.