5 Reasons Why You Want a Partner with Experience for Phase 1 Clinical Trials

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Some of the most critical aspects of clinical research are the early clinical development phases. These critical stages of development not only represent a significant commitment of time and resources for your company, but they can also set the tone and pace for the rest of your product development. One of the easiest ways to help ensure your product’s early clinical development goes smoothly is to partner with a contract research organization (CRO) with experience in Phase 1 clinical trials. This can help you optimize early development phases and avoid delays and cost issues while helping product development succeed.
 

Early Clinical Development
 

Help Optimizing Prep Work and Start-Up Time
 
The first thing an experienced CRO can do is help with prep work. Whether it’s regulatory support, offering staff that can handle protocol development and medical writing, or taking the reins of project management, a CRO can help make preparations go much faster. From clinical monitoring and biostatistics to medical monitoring capabilities, with proper prep work, a CRO can help achieve the study objectives successfully while ensuring safety of study participants.
 
Experience in Volunteer Recruitment
 
Experienced CROs can also support building proper recruitment strategies to ensure timely enrollment and volunteer retention in first-in-human trials. Inclusion and exclusion criteria, such as gender, age, and medical history, must be determined to properly meet the study’s objectives. However, that is only the first step, as participant wait-listing and screening must be performed. Potential participants also need to be well-informed about expectations and stipends, as well as understand procedural requirements. There are many aspects to recruiting participants that experienced CROs can handle that may not be obvious to companies new to clinical development.
 
Ethnobridging Experience
 
If you are thinking of launching your product in other countries, you may want to consider performing Ethnobridging clinical trials. This can help reduce the cost and time of clinical development, as the process recruits ethnic populations without leaving the country. An experienced CRO might have a list of participants available, such as participants with Chinese, Japanese, or Korean ethnicity.
 
Access to Proper Resources 
 
Your company may not have access to the proper resources, such as Phase 1 clinical trial units. These units are where the trial is conducted and can include housing facilities for overnight trials, clean rooms for sterile drug preparation, labs, equipment, and more. They are essential for conducting a Phase 1 clinical trial. If a CRO does not have the proper resources, they likely have an approved vendor list for subcontracting. In short, a CRO will have or have access to the staff, equipment, and resources needed to properly carry out a Phase 1 clinical trial to increase the chances of success.
 
About WCCT Global, an Altasciences company
 
WCCT Global, an Altasciences company, is a full-service early phase contract research organization (CRO) for the pharmaceutical, biotechnology and medical device industries. WCCT offers partners a collaborative, innovative, and agile approach to product development, utilizing specialized regulatory and clinical professionals. The CRO can provide the necessary resources for early clinical development, including a 80,000-square-foot clinical pharmacology unit (CPU) with 180 beds. The CPU is ideal for conducting Phase 1 clinical trials, particularly for studies with an overnight component. This includes a CLIA-certified and CAP-accredited on-site Safety Reference Laboratory as well as a USP-797 compliant room for sterile drug preparation. WCCT has extensive Phase 1 clinical trial experience, with expertise in Ethnobridging, First-in-Human, infectious disease and vaccines, ophthalmology, women’s health, and nicotine and tobacco clinical trials. WCCT is recognized as an industry leader in Asian Ethnic Bridging studies, particularly with Japanese participants.
 
Learn how WCCT’s experience can help you as a partner and sponsor a Phase 1 clinical trial at https://sponsor.wcct.com/

Comments

  1. bioavailability bioequivalence studies5 December 2022 at 05:51

    Thank You! For such great content of Piece on net. We are also provide the clinial trail service. For more contact us today.
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    ReplyDelete

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