Clinical Trial Optimisation for Excellent Delivery

Register Your Interest | Live Online Course

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

 

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If you would like training for yourself or a group, complete the form above

Enrol before | 11 February to save £410 | 18 March to save £210

Discount is applied to the price above. VAT, if applicable, will be added.

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 Classroom Course?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Refreshments and lunch provided on each day
  • Reinforcement session delivered 4 to 5 week after the course (online) providing you with extra time with the trainer
  • A validated certificate of attendance available for you to download
  • Access to the Educo Life Sciences Training Portal before and after the course for additional learning materials

 

Learn more about how we deliver online and classroom training

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
  • Reinforcement session delivered 4 to 5 week after the course (online) providing you with extra time with the trainer
  • A validated certificate of attendance available for you to download

 

Learn more about how we deliver online and classroom training

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
Pricing

There are two price tiers for this course:

  • Super Early Bird Discount – Enrol approximately 3 to 5 weeks before the course starts.
  • Early Bird Discount – Enrol 7 to 10 days before the course starts.
  • The early bird dates for this course are at the top of the page, above Course Overview.

 

Frequently asked questions (FAQs)

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Or please summarise your objectives by completing the form below.

 

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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.