5 Ways to Reduce Start-Up Time in Clinical Trials

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One of the most vital parts of early clinical development is preparing for Phase 1 clinical trials. You will want to work quickly and efficiently without sacrificing the quality of your work. Not only can this give your clinical program positive momentum to carry into later phases, but it can also contribute to saved time and money for your company. Here are some ways to reduce study start-up time for your Phase 1 clinical trial.


Have Dedicated Staff for Functional Areas

In Phase 1 trials including first in human clinical trials, there are a large amount of documents that need to be submitted to an Institutional Review Board in the study start-up phase, which can take several weeks to complete. However, this process can be streamlined by having dedicated staff that can perform the various sub-tasks associated with IRB submissions. Relying on a single coordinator to manage every aspect of this step can be inefficient. Instead, create a team of personnel with various areas of expertise who are responsible for tasks like source document creation, crafting participant-facing materials, creating advertising materials for recruitment, drafting informed consent forms, and submitting to the IRB. By spreading tasks among your staff, you can cut down on the overall time it takes to complete these tasks and move your trial forward quicker.

Have Flexible Resources

No matter the size of your personnel pool, flexibility is essential. For example, you should structure your staff to respond to urgent requests based on need, rather than by the position in a queue. This helps keep your staff from being held back by an inefficient process that can slow down the start-up time. Instead, they are able to re-allocate their attention to the most pressing tasks.

Streamline the Screening Period

A typical screening period is 28 days, but this can be reduced and streamlined with the proper techniques. An effective strategy could be choosing a site with Phase 1 clinical trial units that can facilitate high-volume screening. Plus, if the site has its own lab, it can receive results faster. Flexible screening hours, such as weekends, means more potential participants can be evaluated. A database of potential participants or access to specific communities can also streamline recruitment, helping you create a waitlist for chosen enrollment days even before the screening process has begun.

Implement a Pre-Screening Strategy

If there are specific criteria, such as lab values or genotypes, that a potential participant must meet, it can be beneficial to pre-screen for these values before moving on to a full screening. Create pre-approved consents and use them in advance of the screening process outlined in your protocol. This can help proactively identify ideal participants, focusing specifically on those who meet the pre-screening requirements.

Create a Separate Start-up Contract

Finally, your company may want to create a separate start-up agreement with a contract research organization (CRO). Regardless of the manner in which the CRO handles contracting, one tactic which can help to expedite the time for start-up activities to begin is for the work to be performed under a start-up agreement. Start-up agreements may take the form of other standard agreements or a Letter of Intent (LOI), but the scope of work outlined is specific to start-up activities, with only as much project management time included as will be needed to oversee these tasks. Consider including document creation, IRB submission, training, a site initiation visit, recruitment, advertising, and any necessary screening activities in the agreement. That way, while those tasks are being managed, a second contract for the remainder of the budget can be negotiated and executed.

About WCCT Global, an Altasciences company

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

Partner with WCCT Global to optimize your clinical trial at https://sponsor.wcct.com/

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