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

Posted by WCCT Global on April 12th, 2021

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.

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 for various fixed or flexible costs associated with assumptions made about the schedule. A CRO likely has experience running clinical trials and understands what assumptions should be made and which costs are flexible instead of fixed.

Managing Prep Work

The prep work is not just developing a budget, however. The budget should be developed in tandem with other aspects of prep work, such as project proposals. This includes timelines, clinical conduct plans, and recruitment strategies. You need to make sure your budget and timeline accounts for recruiting activities that occur once the study begins, such as writing participant-facing materials, and advertising for participants.

Protocol Designing and Evaluation

A proper and detailed evaluation of the protocol is vital to a successful clinical trial. Defining the inclusion and exclusion criteria for study participation through factors such as age, gender, and ethnicity is a first step. Other tasks include creating a study design that meets the study objectives and is also attractive for volunteers to participate. Determining whether the participants should be confined to a facility or not, and what kind of procedures and recourses are needed must be carefully reviewed before recruitment begins. Without experience, it can be easy to make a mistake, creating delays in the trial. This also costs resources such as time and money, which your company may not have. CROs either have access to the proper resources or a list of supplemental vendors they can subcontract.

Utilizing Proper Resources

Does your company have access to the necessary resources needed to conduct clinical research? For example, your company may need Phase 1 clinical trial units in which to conduct the study. This can also include overnight units, labs, sterile rooms for drug preparation, and more. Securing proper resources is one of the keys to successfully conduct a clinical trial.

Employing Trained Staff to Perform Research

A CRO can handle medical writing, regulatory support, project management, data management, clinical monitoring and biostatistics, and more. Without prior experience with these, they can be very difficult, again leading to delays. Partnering with a CRO and letting trained staff handle tasks your staff may not have experience with can lead to a successful, streamlined clinical trial.

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.

Partner with WCCT and utilize the CRO’s experience with Phase 1 clinical trials at https://sponsor.wcct.com/

Original Source: https://bit.ly/39PBNqN 

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WCCT Global
Joined: February 8th, 2021
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