Clinical Trial Cost Estimation

Duration: 90 Minutes
In this webinar, we will cover ways to structure the trials so that it is possible to assign cost estimates to the necessary resources over the life of the trial and then estimate the necessary costs by month, year, and total. We will discuss where some of the problems are in getting reasonable estimates, where they can go wrong during the trial and some ways to manage them.
Cost of a Clinical Trial
Product ID: 501814
We will give an example of the use of Excel to do the cost estimation for the various stakeholders over the dates covered by the study. These will be displayed as monthly costs as well as annual and project totals for the resources required for the study.

Objectives of the Presentation
  • How to structure clinical trials so the financial aspects can be better estimated and then managed
  • How written procedures can help manage some of the costs
  • The Development of financial objectives for the participants in the trial
  • The cost of the production of results of the trial
  • What changes might occur that could impact the financial aspects
  • What might be done to manage some of these changes?
Why Should you Attend
The costs of a clinical trial can be quite large involving millions of dollars. A lack of funds can cause serious problems in some trials that could impact results. It is vital that not only the financial staff but also the operations staff understand the financing for the study.

Areas Covered
  • Who are the stakeholders and what is the role of each?
  • The role of SOPs in the finances
  • The inclusion of Lab and other analyses in the costs
  • The inclusion of IT and other support functions in the costs
  • The specification of dates in the cost estimation
  • Doing a 'sensitivity-analysis' for the study
  • Take advantage of similarities in the studies
Who will Benefit
  • Project Managers who manage the conduct of clinical trials
  • Medical professional involved in the conduct of clinical trials
  • Financial staffs in the companies who conduct the trials
  • Financial staffs in the hospitals and clinics who conduct the clinical trials
  • Auditors
  • Compliance Professionals
  • Regulatory affairs
  • Quality Assurance Professionals
  • Consultants
Topic Background
Recent changes in some of the technology used to observe and record study observations require a new examination of the costs to make those observations. This includes those facilities that are starting to use EMR/EHR systems.
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Instructor Profile:
Richard Chamberlain's experience includes consulting with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of computerized project scheduling, strategic planning, Quality Management and Computer Systems Validation. He has also managed large-scale clinical projects including development of Remote Data Entry systems, Adverse Event reporting, Drug Supplies, project planning and supervision of staffs.

Apart from these Mr Chamberlain has taught numerous public and in-house courses on various aspects of Computer Systems Validation and Auditing Computer Systems; assisted in the development and validation of numerous computerized systems in all GxP environments; assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management and Compliance to Regulations. He is also familiar with the various aspects of Computerized Systems and CFR 21, Part 11, FDA Guidelines for Computers, ICH-GCP, and GxPs.
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