How to Find a Contract Research Organization for Your Phase 1 Clinical Trial

By

Deciding to partner with a contract research organization (CRO) can help make your early clinical development smooth and efficient. However, it’s crucial for your company to pick the right CRO for your clinical trial because you will want an experienced CRO that can streamline your study. Here are some of the qualities to look for when trying to find the right CRO to partner with for your Phase 1 clinical trial.


Trained, Experienced Staff

One of the most important aspects of a CRO is the trained staff. They should have experience performing Phase 1 clinical trials and know how to avoid potential pitfalls. Whether it’s project management, data management, biostatistics, or clinical monitoring, the staff should have the right level of training to help make your clinical trial a success. Before selecting a CRO, closely evaluate how the staff is trained and assigned to a particular study. They may need to undergo specific training for your trial, such as using certain methods for collecting blood. Staff should also know how to operate the required equipment for the study. Therefore, your best choice will be a CRO that always strives for improvement and regularly evaluates the efficiency and accuracy of its staffing model.

The Proper Resources for Your Clinical Trial

In addition to providing trained staff members, a CRO should have the proper equipment and resources for your clinical trial. Does the CRO have Phase 1 clinical trial units? These are necessary to conduct the trial, especially when your research includes an overnight component. You may also need an on-site laboratory or a clean room for sterile drug preparation. If the CRO does not have the resources you need, they may have a list of preferred providers available to fill any gaps. It is vital to assess the capabilities and operations of both the CRO and its preferred providers as it pertains to carrying out the procedures defined in the study protocol.

A Database for Recruiting Participants

The next critical aspect of the process is evaluating the CRO’s recruitment databases. The right CRO should have a database of potential participants who may already be eligible for your company’s clinical trial. This is especially important for Ethnobridging studies, which seek to develop a clinical pathway for regulatory approval of a new drug. If the drug is planned for release outside of the US, a CRO can help you find participants of a specific ethnicity within a single geographic region, potentially removing the need to repeat the same study in another country. Partnering with a CRO that has the appropriate databases can significantly expedite your Phase 1 clinical trial.

The Ability to Streamline Your Trial

Ultimately, all these factors help streamline your clinical trial. Before deciding to partner with a CRO, the most important question to ask is whether the organization can help your clinical trial run smoothly, avoiding delays and other hidden costs. Proven experience can help you steer clear of common problems, assisting your company in getting the results it needs 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.

Sponsor your company’s Phase 1 clinical trial with WCCT at https://sponsor.wcct.com/

Comments

Post a Comment

Popular posts from this blog

5 Ways a CRO Can Help Mitigate Delays and Cost Issues in Phase 1 Clinical Trials

By
Image
It can be exciting when your biotech start-up decides it is time to move to  first in human clinical trials . However, that excitement can quickly sour when delays occur or the budget proves to be insufficient. By partnering with a contract research organization (CRO) with experience, your company can avoid delays and cost issues, streamlining trials and successfully moving on to the next phase of product development. Here are some of the ways in which a CRO can help avoid common mistakes and missteps an inexperienced company may make.   Phase 1 Clinical Trial Units Using Experience to Develop a Budget   If your company does not have experience in  early clinical development , it may be easy to misjudge the budget. Resources, supplies, equipment, marketing, and staffing and nursing fees all affect the budget. The Schedule of Events, or SOE, is ultimately what a budget should be derived from. Without a proper SOE, the budget could be off, not accounting f...
Read more

What Is Ethnobridging and Is it Right for Your Phase 1 Medical Trial?

By
Image
When developing a clinical pathway for regulatory approval of a new drug, early clinical development is one of the most critical parts of the overall program. It can set the tone for subsequent phases, determining the pace of the clinical trial. Ethnobridging can reduce costs and development time. Here is how Ethnobridging works and why it might be a good fit for your phase 1 clinical trial. What Is Ethnobridging? Ethnobridging helps demonstrate the equivalence or difference between Asian and non-Asian populations by comparing a drug’s pharmacokinetics after being administered to two or more representative sample groups. The key to Ethnobridging is that clinical trial sponsors can recruit patients in a “global” manner but within a single geographic region and potentially removing the need to repeat the same study in another country. This means the trial’s data regarding the safety and efficacy of the drug are more likely to reduce cost and saving time in the long run, all...
Read more