Overview: This web seminar has been designed to provide you with a clear understanding of project management skills to apply to running clinical trials.
It will ensure you gain a clear understanding of the tools and techniques of project management for clinical trial 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 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?
o Defining the key characteristics of project management and the importance to clinical trials
o Using an project management process for improving the success of your own clinical trials
* Setting clear objectives and defining the scope of your projects
o Aligning the project objectives with the strategic and financial business objectives
o Understanding the importance of having an overall strategy for your research projects
* Developing a detailed project plan to manage your clinical trials
o Identifying the key project activities
o Planning a realistic schedule
o Budget planning
o Implementing risk management and contingency planning
* Project Implementation and control
o Identifyin
It will ensure you gain a clear understanding of the tools and techniques of project management for clinical trial 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 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?
o Defining the key characteristics of project management and the importance to clinical trials
o Using an project management process for improving the success of your own clinical trials
* Setting clear objectives and defining the scope of your projects
o Aligning the project objectives with the strategic and financial business objectives
o Understanding the importance of having an overall strategy for your research projects
* Developing a detailed project plan to manage your clinical trials
o Identifying the key project activities
o Planning a realistic schedule
o Budget planning
o Implementing risk management and contingency planning
* Project Implementation and control
o Identifyin
