4 Things to Look for When Launching a Phase 1 Clinical Trial

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. Having the proper resources and providers available before beginning any clinical trial can help the trial run smoother than if you wait to determine these specifics until the trial is already underway.

Finding the Right Staff

Next, you need to be mindful of finding staff members with the proper level of training, whether they be investigators, nurses, project managers or lab coordinators. If you partner with a CRO with Phase 1 clinical trial units, the organization may provide a staff to assist with the trial. Otherwise, you will need to recruit staff members on your own. Doing so before research begins can help the trial run efficiently, saving you time and money.

Recruitment Practices

In order to secure enough volunteers who are willing to participate in your phase 1 clinical trials including first in human clinical trials, you will need a process that helps you find potential participants who correspond to the inclusion and exclusion criteria defined in the protocol. Demographic factors might include age, gender, and ethnicity, tailored to fit the objective of your research. It is also important to have a study design that is attractive to potential participants. Making errors or including inconsistencies when creating recruitment practices for your study is all too common. Therefore, it’s critical to carefully review all possible variables before you begin recruiting. Otherwise, you could run into costly delays.

Should You Partner with a CRO?

The final, crucial question is whether you should partner with a CRO or not. A CRO can be a major advantage during your Phase 1 clinical trial and beyond, with the ability to provide trained staff to help conduct research, Phase 1 clinical trial units to execute the study, and even a list of preferred providers to obtain external resources. Choosing a CRO with experience means a far lower chance of delays in creating recruitment procedures and study protocol, managing prep work like the Schedule of Events, and finding reliable outside providers that have already been vetted and approved. The CRO might even have a database with a list of potential participants, helping you carry out your study involving Ethnobridging or any other research methods with ease.

About WCCT Global, an Altasciences company

WCCT Global, an Altasciences company, is a full-service early phase contract research organization (CRO) that caters to the pharmaceutical, biotechnology, and medical device industries. Partners sponsoring a clinical trial with WCCT are offered an innovative, collaborative, and agile method to clinical research. The CRO utilizes specialized regulatory and clinical professionals for an unmatched research experience. WCCT offers partners essential early clinical development resources, including an 80,000-square-foot clinical pharmacology unit (CPU) that provides 180 beds for Phase 1 clinical trials. The CPU also includes a USP-797 compliant room for sterile drug preparation and a CLIA-certified and CAP-accredited on-site Safety Reference Laboratory. WCCT has extensive Phase 1 clinical trial experience and offers expertise in Ethnobridging, First-in-Human, infectious disease and vaccines, ophthalmology and women’s health clinical trials. The CRO is recognized as an industry leader in Asian Ethnobridging studies, particularly with Japanese participants.

Partner with WCCT for efficient Phase 1 clinical trials at https://sponsor.wcct.com/

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