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WCCT Global
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Our Mission: To advance global health by transforming clinical research.
Our Mission: To advance global health by transforming clinical research.

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When Phase 1 site you are using or have used in the past receives an FDA 483, should you still consider using that site in the future? At some point or another, every Phase 1 site has received or will receive a 483, so this is something that Sponsors and CROs should be prepared to address.
In this article, we’ll dive deeper into what it means what a Phase 1 site receives an FDA 483, and what items Sponsors and CROs should consider before determining how to proceed with the unit. To read the full article, visit us at our website here:

https://wcct.com/phase-1-clinical-trial-unit-fda-483/
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When it comes to large Phase 1 clinical trials, it is important that the staff at your sites are optimized for the best study conduct possible. However, when there are a large number of volunteers, as well as stringent protocol requirements, staff optimization can be difficult to accomplish.

The following case study will highlight one of WCCT Global’s recent Phase 1 clinical trials, in which they were tasked with accelerating timelines for the Sponsor, while utilizing staff in the most efficient manner possible and keeping deviations to a minimum. To download the case study, visit our website here:

https://wcct.com/staff-optimization-phase-1-clinical-trials/
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When it comes time to selecting clinical phase 1 units for a large study, there are a number of items to consider when making a decision. One such item is whether or not staff are properly optimized for efficient performance during Phase 1 studies. An optimized group of study personnel can be the difference between the success or failure of a program.
In our experience conducting Phase 1 studies, we found that three strategies can help improve the overall efficiency and performance of staff at clinical Phase 1 units. Read the full article here:
https://wcct.com/optimizing-staff-clinical-phase-1-units/
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While most Phase 1 research units will have SOPs which cover how to respond to emergencies and adverse events in a general sense, very few sites take the time to develop extensive Risk Mitigation Plans that are tailored to address specific protocols.
By creating a Risk Mitigation Plan, stakeholders can produce a systematic approach to identifying risks before the trial has begun, and establish steps for prevention as well as contingencies should they occur.
In this white paper, we’ve compiled considerations and strategies for developing a successful Risk Mitigation Plan. To download the white paper, visit us here:

https://wcct.com/risk-mitigation-plan-phase-1-studies/
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Are Your Phase 1 Studies at Risk?

Phase 1 trials can set the groundwork for the entire clinical development process of new treatments, and thus, every possible measure to prevent risks and deviations should be taken during the earliest stages of planning.

However, identifying potential risks for your clinical program isn’t a difficult exercise. In this article, we’ll show you where risks can easily be identified so that they may be prevented, and contingency plans may be created. To see the full article, visit our website at the link below:
https://wcct.com/preventing-risks-phase-1-clinical-trials/
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You receive a budget from a site regarding an upcoming Phase 1 clinical trial. It’s fairly broad, but you don’t necessarily know the ins and outs of the budgeting process…so how can you be certain you are receiving fair market priced services?

In this white paper, we’ll help you identify some key elements within a budget which can help you determine if you are receiving the best value from your Phase 1 sites. By doing so, Sponsors and CROs will be equipped to better evaluate the sites they are using for Phase 1 programs, and make better decisions regarding their usage.

To download the white paper, visit our website here:
https://wcct.com/phase-1-clinical-trial-budget/
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Need to Reduce the Cost of Phase 1 Clinical Trials?

With development costs at their current level, it’s no surprise that Sponsors are always are looking for ways to keep costs down and bid more competitively on work for Phase 1 trials.

One strategy for reducing the cost of Phase 1 studies is to choose sites that are providing a fair market value to the Sponsors. However, sites are only capable of doing this when they have a firm understanding of their internal operations and other factors.

To find out how Phase 1 sites can ensure fair market value and decrease the cost of Phase 1 trials, see the full article at here:
https://wcct.com/reducing-cost-of-phase-1-clinical-trials/
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Are you incorporating these 5 critical considerations during Phase 1 site selection?

Last time, we provided a list of “standard criteria” for the selection sites for Phase 1 clinical trials. However, we felt that it was important to include some “advanced criteria” for selecting sites as well. This criteria tends to be a bit more detailed and dive into some of the more nuanced aspects of a Phase 1 site’s operations and capabilities.

To see our list of advanced criteria for selecting Phase 1 sites, read the article posted on our website:
https://wcct.com/phase-1-clinical-trial-unit-advanced-selection/
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Are you applying the correct criteria for Phase 1 Site Selection?

When it comes to selecting Phase 1 sites, especially for large studies, Sponsors and CROs can reliably use some standard criteria to assess the ability of the site to conduct their trial safely and successfully.

While these criteria are not an exhaustive list of all that could be asked of a Phase 1 site, they will provide a good foundation for selecting and re-evaluating sites for Phase 1 clinical trials. To see our list of standard criteria, visit our website at the link below:
https://wcct.com/clinical-phase-1-units-selection/
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