Decentralized elements, such as telehealth visits, home nursing, electronic consent, direct-to-participant shipment of investigational product, and remote assessments, change a study's scope, vendors, site roles, and budget. When a sponsor decides which of these elements the study will use before the RFP, every CRO prices the same model, and the proposals reveal real differences in experience and execution. When the decision waits until after award, it usually arrives as a series of change orders and a revised startup plan.
What counts as a decentralized element?
The term covers any trial activity that takes place somewhere other than the investigator's site. Common examples include:
Telehealth visits in place of some on-site visits
Home visits by mobile research nurses
Assessments performed by a participant's local health care provider
Electronic informed consent, completed remotely or on site
Electronic patient-reported outcomes and other electronic clinical outcome assessments
Wearables and other digital health technologies that collect data remotely
Direct shipment of investigational product to participants
What does FDA's guidance say?
FDA issued final guidance titled Conducting Clinical Trials With Decentralized Elements on 17 September 2024. It confirms that decentralized elements can be incorporated into trials of drugs, biologics, and devices, and it discusses practical considerations, including investigator oversight of activities performed by others, the use of local health care providers, safety monitoring, the handling and shipment of investigational products, and the use of digital health technologies. The same regulatory requirements apply whether an activity happens at the site or elsewhere, so the design question is operational: which elements fit this study and these participants.
How do you decide which elements fit your study?
Start with the participant. Long travel distances, frequent visits, and mobility limitations are strong reasons to consider remote options. Then weigh the constraints. Some assessments, such as imaging or certain procedures, require a site. Products with complex storage or administration requirements may not be suitable for home delivery. Early-phase studies with intensive safety monitoring usually need more on-site time than later-phase studies of well-characterized products. Country requirements also differ, so an element that works in one region may need adjustment in another.
What does each choice mean for vendors and budget?
Each element typically brings a vendor and a workflow: a home nursing provider, a depot able to ship directly to participants, an electronic outcome assessment vendor, or a device logistics partner. Fewer site visits can reduce investigator grants and monitoring travel, while vendor fees, training, and integration work add cost. The net effect varies by study. In my experience, the strongest case for decentralized elements is usually retention and access, with cost a secondary consideration.
How should the RFP describe the plan?
Be specific. State which visits will be remote or at home, the expected number of each, which assessments will be collected electronically, and whether investigational product will ship directly to participants. Name any vendors you intend to contract directly. Then ask each CRO to describe its experience with each element, how it integrates third-party vendors into monitoring and data flows, and how site staff are trained and supported.
What should you watch for?
Proposals that price a different mix of remote and site visits than you described
No plan for how investigators will oversee activities performed by home nurses or local providers
Data from remote assessments that do not flow into the main database on a clear schedule
Country assumptions that overlook local restrictions on direct-to-participant shipment
Site budgets that do not reflect the remaining site responsibilities
Keep reading: Decide Your Monitoring Strategy Before the RFP
