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Optimize Labor and Skills in Early Phase Clinical Trials with Intelligent Staff Resourcing

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The success of a Phase 1 clinical trial can come down to how optimally you assign clinical site personnel. Without strategic planning, a study could potentially incur high costs or face other obstacles for trial sponsors. How, then, can you ensure that the staff chosen for your Phase 1 clinical trial units is being assigned correctly to keep costs down and create efficient processes? Here are some tips for evaluating the variables at your clinical trial location. Utilize General Training Each Phase 1 clinical trial unit will have general training and onboarding for new staff. This may consist of reviewing the employee handbook, completing coursework and certification requirements, competency testing before receiving a procedural assignment, ICH (E6) and GCP guidelines, and other types of training. However, what’s most important is that staff are trained for specific procedures in your clinical trial protocol. For optimal efficiency, staff should be familiar with protoco...
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4 Keys to a Successful Phase 1 Clinical Trial

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Many of the factors that can lead to a successful Phase 1 clinical trial involve the setup of the trial itself. Early clinical development , especially Phase 1 trials, will set the pace, standards, and trajectory for the remainder of the clinical development program. Having the right staff and resources can help avoid delays and hidden costs, streamlining the clinical trial and producing a successful study. Here are some of the factors to keep in mind that can help increase your chance for a smooth, successful clinical trial. Access to Potential Participant Databases When your organization moves to first in human clinical trials , you need participants. If you have access to potential participant databases before you start recruiting, then the work of establishing a pool of potential participants has already been done. Generally, it’s easiest to partner with a contract research organization that already has access to databases or specific populations of potential participa...
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How to Prepare for Early Phase Trials with a Specific Patient Population

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When moving to a Phase 1 clinical trial, your company might decide that you want to include a specific population for several reasons. Whether it’s targeting a particular trait for a cohort(s) of the study or the study is using Ethnobridging , you might have more variables to factor into the study than the average Phase 1 clinical trial. Here are some additional participant-related considerations to keep in mind when planning for your clinical trial. Consider the Study Design Are you planning on enrolling the specialty population simultaneously as the general participants? It can be challenging to randomize a full cohort of over 8 participants concurrently in the same way a normal healthy volunteer cohort would be structured. In our experience, allowing for flexibility in scheduling confinement and follow-up visits can be beneficial and attractive to patients and in turn make the study easier to enroll. If the specialty population cohort won’t be enrolled until all NHV cohorts have b...
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5 Ways to Reduce Start-Up Time in Clinical Trials

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One of the most vital parts of early clinical development is preparing for Phase 1 clinical trials. You will want to work quickly and efficiently without sacrificing the quality of your work. Not only can this give your clinical program positive momentum to carry into later phases, but it can also contribute to saved time and money for your company. Here are some ways to reduce study start-up time for your Phase 1 clinical trial. Have Dedicated Staff for Functional Areas In Phase 1 trials including first in human clinical trials , there are a large amount of documents that need to be submitted to an Institutional Review Board in the study start-up phase, which can take several weeks to complete. However, this process can be streamlined by having dedicated staff that can perform the various sub-tasks associated with IRB submissions. Relying on a single coordinator to manage every aspect of this step can be inefficient. Instead, create a team of personnel with various areas of experti...
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The Importance of Partnering with the Right CRO for Your Phase 1 Clinical Trial

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If your organization is moving to Phase 1 clinical trials but lacks experience managing clinical trials, it is vital to partner with a clinical research organization (CRO). A CRO can help facilitate a successful clinical trial, expediting  early clinical development  and preparing for unforeseen variables to avoid delays and hidden costs. Your organization must choose a CRO that is a good fit for your company and the clinical trial. Here are some of the reasons it’s essential to partner with the right CRO for your clinical research.     Utilize the CRO’s Experienced Staff   Having staff experienced in managing a Phase 1 clinical trial is essential if you want to avoid roadblocks before and during the clinical trial. From knowing the correct way to create source documents to crafting participant-facing materials or handling submissions to an Institutional Review Board, a knowledgeable staff that has performed these tasks before can help to streamlin...
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4 Reasons Not to Start a Phase 1 Trial Without a CRO

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Trying to start a Phase 1 clinical trial without the proper resources and experience could potentially lead to unsatisfactory results. Additionally, it could cause delays and hidden costs, quickly outpacing the budget of the study. There are plenty of reasons your organization might not want to start  early clinical development  without help from a contract research organization (CRO). Here are some of the most important variables to consider.     Delays From Errors in Paperwork or Procedures   Without proper experience in early clinical development, the beginning phases of your study can grind to a halt. Any clinical trial requires plenty of paperwork to fill out, procedures to determine and submissions to make. Trying to complete these without an experienced team can lead to delays, including the need to redo submissions or refine your procedures. Partnering with a CRO means your trial has access to a team with experience writing these documents a...
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How to Find a Contract Research Organization for Your Phase 1 Clinical Trial

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Deciding to partner with a contract research organization (CRO) can help make your early clinical development smooth and efficient. However, it’s crucial for your company to pick the right CRO for your clinical trial because you will want an experienced CRO that can streamline your study. Here are some of the qualities to look for when trying to find the right CRO to partner with for your Phase 1 clinical trial. Trained, Experienced Staff One of the most important aspects of a CRO is the trained staff. They should have experience performing Phase 1 clinical trials and know how to avoid potential pitfalls. Whether it’s project management, data management, biostatistics, or clinical monitoring, the staff should have the right level of training to help make your clinical trial a success. Before selecting a CRO, closely evaluate how the staff is trained and assigned to a particular study. They may need to undergo specific training for your trial, such as using certain methods for collec...
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