Clinical Research Blog Series: Reducing Start-Up Time in Early Clinical Development—Start-Up Agreements
Time is of the essence when it comes to early clinical development. In this clinical research blog series, we will focus on how Sponsors can reduce start-up timelines in Phase 1 trials through various creative tactics. The first of these strategies is to utilize a Start-Up Agreement (or contract).
Hit the Ground Running with Start-Up Agreements
Site identification in early clinical development comes with a unique selection process that is centered around staffing models, operational processes, and access to certain types of equipment or facilities. Due to the complexity of these various criteria, this selection process can take more time than might commonly be anticipated. One item that is often overlooked is a site’s contracting process; depending on the type of site (academic, institutional, commercial, etc.), the contracting process will vary and could be lengthy. It is not uncommon for higher dollar contracts to require more involvement from upper management (on both sides), thus extending the contracting process further.
Regardless of the manner in which the Phase 1 site 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.
The benefits of a Start-Up Agreement are many. First and foremost, the site is protected and can perform relevant activities without the risks associated with the study being cancelled or put on hold unexpectedly. Second, since the scope of work tends to be for smaller time frames and is centered around the completion of specific tasks, the dollar amounts are much smaller and easier to agree upon by both parties.
While the Start-Up activities are being performed, the remainder of the budget and a subsequent agreement can be negotiated and executed in time for dosing activities.
Be on the lookout for the next topic in this clinical research blog series—the utilization of flexible and functional staffing models to streamline IRB Submissions.