5 Questions You Should Ask Before Partnering with a Phase 1 Clinical Unit

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 your research warrants, the site should provide a detailed review and proposals for intervals between assessments, prioritization of procedures, assumptions they have made, and any points on which they need further clarification.

Does the Study Have Specific Staffing Needs?

Much like the previous question, if the site makes blanket assumptions about first in human clinical trials, your trial’s staffing needs may not be properly met. Each first-in-human clinical trial is different, and assumptions on the part of the Phase 1 clinical unit can lead to increased costs and significant risk for subject safety. Determining where and when staff is needed as well as the level of training needed for staff, whether that be investigators, doctors, or nurses, can help ensure the trial runs smoothly without costing you valuable time or money.

How Are the Staff Trained?

There is no right or wrong answer to this question, but sponsors should note whether their staff is trained to have dedicated expertise and specify which staff members handle screening activities and data entry. At the very least, the staff should be trained to carry out the study’s procedures as defined in the protocol, even if they have prior experience with similar methods.

How Does the Site Maintain Their Participant Database?

Sites should be able to give sponsors a clear understanding of how participant databases are maintained. Ask the site how often their database metrics are updated, what kind of system runs queries and reports, and how the site segments data. This can help give you an understanding of how quickly and efficiently the site will be able to recruit participants for your Phase 1 clinical trial and track your findings.

What Happens When the Resources You Need Are Unavailable?

While the site itself is essential, the vendors that the site chooses to handle situations when specific resources are unavailable are also critical to the trial. Can the vendors adequately handle any risks associated with the study? Are the vendors well-versed in how to handle specific situations that could occur during the study? Have the vendors been assessed by qualified site personnel? Sponsors should examine the site’s previous experience and relationship with vendors for a better overall understanding of the vendor.

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 biotechnology, pharmaceutical, and medical device industries. When sponsoring a clinical trial with WCCT, partners are offered a collaborative, innovative, and agile approach to clinical research. WCCT achieves this by utilizing specialized regulatory and clinical professionals. The CRO offers partners the necessary resources for early clinical development, including an 80,000-square-foot clinical pharmacology unit (CPU) with 180 beds, which is ideal for conducting Phase 1 clinical trials. The CPU includes a CLIA-certified and CAP-accredited on-site Safety Reference Laboratory and a USP-797 compliant room for sterile drug preparation. With extensive Phase 1 clinical trial experience, WCCT has expertise in Ethnobridging, First-in-Human, infectious disease and vaccines, ophthalmology, women’s health, and nicotine and tobacco clinical trials. WCCT is also recognized as an industry leader in Asian Ethnic Bridging studies, especially with Japanese participants.

Partner with WCCT and utilize Phase 1 clinical trial units at https://sponsor.wcct.com/

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