Description

This web seminar has been designed to provide you with a clear understanding of project management skills to apply to running phase 3 clinical trials.

It will ensure you gain a clear understanding of the tools and techniques of project management for phase 3 clinical trials and how they can be applied to your own pharmaceutical projects in the work place. In addition to key project management tools and techniques a checklist of over 100 clinical trial activities for a phase 3 clinical trial will be supplied as part of the seminar, which will include the following:

Obtain a brief from the Project Sponsor which defines the clinical trial objectives, rationale, outline timeframe, and estimated budget available
Review literature and other available information
Discuss the therapeutic areas with experts in the company and externally such as key opinion leaders, patient groups may also be of help
Decide on the study design potential locations for the study (eg which countries have a high incidence of the disease, where do you propose to market the drug
Identify potential locations for the study (eg which countries have a high incidence of the disease, where do you propose to market the drug
Obtain statistical input to calculate sample sizes and prepare the statistical plan.
Ensure availability of suitable non-clinical and clinical research data (eg Phase 1, phase II) information to justify carrying out this clinical study
Prepare outline of the protocol
If the study is carried out in EU obtain the EUDRACT number in accordance with the Clinical Trial Directive requirements
Start to prepare the outline plan for the study using the work breakdown structure (WBS) technique, outline Gantt chart with estimated timelines for main activities of the study
Identify possible project risks and uncertainties. Prepare a risk register to handle risks develop contingencies and how you can mitigate risks
Identify which departments are going to be involved in the study and start to identify key people from these departments who will be a part of the study team.
Prepare the a list of key stakeholders for the project
Decide on test drug(s) and comparator drug(s).
Check availability of study medication and place provisional order so as to prevent this becoming a rate limiting activity. The exact quantities can be refined later. Ensure the qualified person (QP) has been contacted in order to help prevent delays in obtaining the study medication
Prepare a contingency plan for unavailability of comparator drugs in some countries.
Decide on detailed timelines for study preparation, performance, and evaluation, including critical time points.
Start some initial feasibility into the countries of interest.
Ensure investigator brochure is available
Identify and decide on study management technologies and processes i.e. specific project management software to be used in the study, is the study going to use electric data capture.

Areas Covered in the Session:

What is a Project and why is it important for running clinical trials?

Defining the key characteristics of project management and the importance to phase 3 clinical trials
Using an project management process for improving the success of your own clinical trials

Setting clear objectives and defining the scope of your projects

Aligning the project objectives with the strategic and financial business objectives
Understanding the importance of having an overall strategy for your research projects