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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...

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...

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...

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...

Launching a Phase 1 clinical trial can be an exciting time for any company developing a clinical pathway for regulatory approval of a new drug. Early clinical development is an essential aspect of development and helps set the tone for subsequent phases and guide further research. Since this step is so important, there are a few critical puzzle pieces to fit together before a trial can start. From obtaining the proper resources to conduct a Phase 1 clinical trial to ensuring sound recruitment practices, here are four things to keep in mind. Obtaining the Proper Resources The first step is obtaining the proper resources. You might need specific equipment or expertise in a particular aspect of conducting research, and you may need to obtain these from outside providers or through a contract research organization. Finding Phase 1 clinical trial units is essential, especially if your trial includes an overnight component. You might also need labs and sterile rooms for drug preparation....

When choosing Phase 1 clinical trial units for your clinical research, there are several critical questions to ask. Trial sponsors and CRO partners often establish lists of preferred providers; when developing these lists, it’s vital to obtain information that adequately assesses capabilities and operations. This way, sponsors won’t overlook key factors regarding potential Phase 1 clinical trial units. Here are some questions you should ask potential Phase 1 unit vendors during site selection to ensure they are a good fit. Does the Site Team Have a Tailored Plan to Conduct the Study? The site might have a general plan to conduct studies, but having an optimal plan that can be tailored to your specific research objectives is best. Sites should evaluate your study protocol in detail, developing specific strategies to conduct your research. Instead of simply looking at basic information for early clinical development , such as the number of subjects, visits, and procedures yo...