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Clinical Trial Optimisation for Excellent Delivery

Register Your Interest

This course will take you through the ‘Story’ of delivering excellent clinical trials from protocol to clinical study report

 

This course is currently not scheduled however it can be delivered for your team. To register your interest, complete the form below

Register Your Interest

 

Register your interest in the course. When we schedule dates, we will be in touch.

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Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

Course Overview

 

Clinical trials form a vital part of the drug development process, however they are expensive to run and time consuming. Sponsors and CROs are continually looking for new ways to optimise trial design and process to improve efficiency. As technology and methodology advances, there have been changes in clinical trial design and strategy.

 

This training course will look at best practice to optimise the clinical trial process, to ensure you have an efficient and effective approach to your clinical trials. Once completed, you will have the skills to save your organisation valuable time and money. You will examine the clinical process from protocol design to the clinical study report discussing best practice, strategies and the latest methodologies enabling you to develop your skills in this crucial area.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development.

 

Learn more about how we deliver online and classroom training

Key Learning Objectives

 

  • Learn how to develop and deliver inspection ready clinical trials
  • Describe how critical detailed preparation leads to clinical trial success
  • Detail the key points for site selection, contracting and management
  • Appreciate key steps for vendor selection and contracting
  • Construct an issue management process to include escalation through resolution
  • Comprehend process and benefits for Centralised and Risk Based Monitoring

What is Included in a Live Online Course?

 

  • Direct access to an expert trainer.
  • Interactive and engaging sessions with exercises and discussions.
  • Bitesize learning.
  • Access to the Educo Life Sciences Training Portal.
  • Unlimited access to the recordings for 4 to 5 weeks after the last session.
  • A reinforcement session delivered 4 to 5 weeks after the course (online) providing you with extra time with the trainer.
  • A validated certificate of attendance is available for you to download.

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

Dates TBC

1 Week Live Online Training
Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Free Online Module

 

  • Module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
  • To register for module 1, please submit your details in the form located in the agenda.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.

 

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered either online or in a classroom. Please check which course format you have booked.
  • For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)

Post Learning Implementation Plan (PLIP)

Pre-course

  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover subsequent questions and challenges
Module 1

Project Definition:  Understanding your clinical trial and your resources

  • Begin with the end goal. Programme or single clinical trial?
  • Who will support project delivery?
  • RACI: Activity Design your RACI
  • Understand the roles and responsibilities at Sponsor, CRO, Vendor, Technology providers and Investigational sites
  • Stakeholders
  • Activity: Understand your team

 

Module 2

Protocol design to protocol deviations

  • Inherent Quality by Design (ICH E8 R1 and ICH E6 R3)
  • Critical to Quality Factors
  • Promoting High-Quality Studies
  • Defining Study duration
  • Minimising the number of Protocol amendments
  • Minimising the number of Protocol deviations
  • Managing Protocol Deviations
  • Activity: Poor Design, Poor Delivery
Module 3

Project risk analysis and management

  • Project Risk Analysis and Management for Clinical Trials
  • Driven by ICH E6(R2) Good Clinical Practice
  • Centralised and Risk Based Monitoring
  • Risk Indicator Library and how to use
  • Activity: Work with Key Risk Indicators

 

Module 4

Selection, contracting and oversight of vendors

  • Selection of Vendors to deliver your protocol
  • Contracting with Vendors
  • Oversight of Vendors to meet regulatory expectations
  • Technology in Clinical Trials
Module 5

Prioritise, plan and enrol evaluable subjects

  • Effective Study Feasibility: And now for the patients
  • Estimate Study Enrolment and produce Enrolment Plan
  • Communication of Clinical Trial Priorities: Activities essential to the project
  • CASE STUDY: It all went wrong before it even started
  • Activity: Patient Recruitment challenge
Module 6

Crises, issue management and CAPA’s

  • Clinical Trial Crises
  • Issue identification and management
  • CASE STUDY: Protocol Adherence during COVID-19 Pandemic: Budget impact?
  • Activity: Patient Recruitment Issue
  • Corrective And Preventive Action (CAPA) plans
  • Clear issue documentation for ongoing Inspection Readiness.
  • Activity: Use of root cause analysis
Module 7

Budget Planning and Management

  • FTE calculations
  • CRA resource allocation
  • Activity: Budget Understanding
  • CASE STUDY: Protocol adherence during COVID-19 Pandemic Budget Impact
  • TMF
Module 8

Clinical trial close out

  • LPLV to Database lock = 5 business days
  • Site Close Outs
  • Budget and Contracts Close Out
  • Technology close out/finalisation and archive
  • Inform Regulatory Agencies study has closed/completed/terminated
  • Study Close and Document Archiving
  • eTMF final QC, close out and archive
  • Lessons Learned for subsequent studies
  • Activity: Lessons learned

Julianne Hull – With 30+ years of global leadership experience within the pharmaceutical industry, Julianne has broad and in-depth knowledge of how Clinical Trials work. Having been a global leader for operations planning and vendor management within Wyeth she established and led the fora to ensure collaborative cross-functional delivery of all phase 1 to 3 clinical studies. Julianne has worked in the large, medium, and small pharma providing valuable perspectives on the varying constraints and enablers to project delivery.

 

Julianne delivers training programmes globally on several different clinical topics bringing her real-life experiences to the classroom. Julianne has an easy and interactive style which ensures the class engage and take the most from the training.

The course is aimed at those involved in the planning and conducting of clinical trials from both sponsors and vendors such as:

  • Clinical Research Associate
  • Clinical Trial Manager
  • Clinical Project Manager
  • Clinical Operations
  • Vendor Oversight and Management
  • Clinical Quality Management
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