How to Optimize Your Phase 1 Clinical Trials

Posted by WCCT Global on March 16th, 2021

How your early clinical development goes when developing a product can be critical to the rest of development. It’s not only the start of a significant commitment of resources but can set the pace and tone of the rest of your product development. If you want a smooth, optimized Phase 1 trial, there are specific actions you can take to help ensure you get accurate results in a timely manner. Here is what your company can do to optimize your Phase 1 clinical trials to have a smooth development cycle.

Do the Prep Work

Paving the way for smooth first in human clinical trials starts long before the study is put in motion. With the proper preparation, everything else moves faster and has fewer chances of encountering a snag in the process. You should already have in place regulatory support, staff to handle protocol development and medical writing, project management, data management, clinical monitoring and biostatistics, and medical monitoring capabilities to help ensure the safety of participants before the study begins.

Set Up Proper Recruitment Plans

Before recruiting, inclusion and exclusion criteria, such as gender, age, ethnicities and medical histories should be properly set to meet the objectives of the study. Certain procedures such as pre-screening, participant wait-listing, and the ability to conduct flexible screening activities need to be put in place. Participants should have well-informed expectations for stipends and understand procedural requirements, and transportation support should be available.

Perform Ethnobridging 

Your company should consider performing Ethnobridging, such as including participants of Asian descent (Japanese, Chinese, or Korean, for example) to your study. This can help alleviate the need, for example, to perform the Phase 1 trial in Asia. It can also streamline the Phase 1 clinical trial process without leaving the country, while lowering the cost and reducing product development time.

Acquire the Resources You Need

Your company will need to acquire resources to do the Phase 1 clinical trial, as well. You may need a laboratory or a sterile room for drug preparation. You will need Phase 1 clinical trial units to cover all aspects of your needs, including equipment, labs, and even housing for participants. With these resources in place, it’s much easier to get the product development underway rather than waiting and having to delay the process later in order to acquire them.

Partner with a CRO

If your company has neither the resources nor experience to do any of the above, it might be worth partnering with a contract research organization. A CRO will have the trained staff and resources to help you streamline the process. This will help with the prep work and performing a Phase 1 clinical trial quickly and accurately. If the CRO does not have the resources, they often have a list of qualified vendors to subcontract parts of the study.

About WCCT Global

A full-service contract research organization (CRO), WCCT Global caters to the pharmaceutical, biotechnology, and medical device industries. Utilizing clinical and specialized regulatory professionals, WCCT offers partners a collaborative, innovative, and agile approach with every program the WCCT team delivers. When partnering with WCCT, they can provide resources, including a 75,000-square-foot clinical pharmacology unit (CPU) with 180 beds, ideal for conducting Phase 1 clinical trials, especially with an overnight component. They also offer an on-site Safety Reference Laboratory that is both CLIA-certified and CAP-accredited, as well as a USP-797 compliant room for sterile drug preparation. WCCT has extensive Phase 1 clinical trial experience, with areas of expertise including Ethnobridging, First-in-Human, infectious disease and vaccines, ophthalmology, women’s health, and nicotine and tobacco clinical trials. They are an industry leader in Asian Ethnic Bridging studies, specifically with Japanese participants.

 Streamline and optimize your company’s Phase 1 clinical trial by partnering with WCCT Global at https://sponsor.wcct.com/ 

Original Source: https://bit.ly/3bvw0rS