When decentralized or hybrid study models are introduced, the industry often talks about patient convenience, expanded reach, and flexibility. BUT – what does it actually cost a site to run a decentralized trial? And how should sites price that work in a way that reflects reality, scale, and sustainability?
Sponsors often treat DCT as if it reduces site workload. In truth, decentralized elements typically increase the volume, the complexity, and the regulatory responsibility held by the site. That means every DCT study requires a different budget architecture than a traditional onsite model.
This isn’t about “charging more;” it’s about charging correctly – because decentralized trials shift the work but do not remove it. In many cases, they magnify it.
Why DCT Costs More for Sites
A decentralized visit still requires:
- scheduling
- documentation
- PI oversight
- data review
- essential document maintenance
- delegation
- safety follow-up
- reconciliation of remote assessments
- proof of oversight across multiple environments
In a decentralized model, the site becomes the orchestrator, not just the care provider.
That orchestration requires labor, training, system support, and infrastructure the traditional budgets do not cover.
On top of that, DCT scales differently:
- A site with 30 patients in a DCT study could translate into double the actual oversight needed of a traditional model.
- A site managing one remote procedure may coordinate with three different vendors for that one task.
- A PI overseeing remote assessments requires systems, documentation, and manpower – even if the PI never sees the patient in person; PI oversight expectations are unchanged. At a high level, they will oversee:
- Distributed care providers
- Remote assessments that lack in – person clinical cues
- Multiple remote vendors performing trial – critical tasks
- Technology – based data pipelines with new integrity risks
- Remote consent quality and identity confirmation
- Patient wellbeing without physical presence
- Privacy and security across decentralized tools
- Digital literacy and device compliance support
The PI’s responsibilities do not change – but the mechanisms to fulfill them are completely different, and the burden shifts to system-level oversight rather than direct observation.
Scale in DCT is not linear – workload rises faster than enrollment – a reality the budget must reflect.
The Non-Negotiable Line Items DCT Must Include
Below are the items that must appear in a decentralized study budget. Most of these never exist in a traditional budget model – and if they don’t appear, the site is absorbing the cost.
Each one represents a real, measurable operational burden.
Home – Health Oversight & Delegation Management
Sites must:
- vet, document, and delegate home – health staff
- maintain credentials
- track training
- provide protocol – specific instructions
- perform periodic oversight
- reconcile documentation of visits they didn’t attend
This is not standard coordinator work, it is a new, high – liability category of oversight.
Budget line:
Home – Health Oversight / Remote Delegation Per – Patient Fee
Or
Monthly Home – Health Oversight Administrative Fee
Remote Visit Coordination & Logistics
Coordinators spend significant time:
- scheduling remote visits
- coordinating supply shipments
- tracking IP/study materials to and from individual patients
- confirming availability of home – health or virtual appointments
- documenting logistics
- troubleshooting issues
Budget line:
Remote Visit Coordination Fee (per remote visit)
Device / Technology Onboarding & Troubleshooting
Sites must now:
- train patients on devices
- document that training
- support device syncing
- troubleshoot device failure
- reconcile incomplete or missing data
- maintain device accountability logs
- escalate issues to vendor support
- re – educate patients when app updates change workflows
Budget line:
Device Support & Digital Troubleshooting Fee (per patient per month)
Or
Technology Integration Fee (one-time + ongoing)
Remote Informed Consent Administration
Remote consent requires:
- telehealth documentation
- identity verification
- eSignature workflow management
- version control across platforms
- PI oversight verification
It is more burdensome than in-person consent in many cases.
Budget line:
Remote Consent / eConsent Facilitation Fee
PI Oversight of Decentralized Activities
A PI must oversee:
- assessments performed at home
- data collected via devices
- safety events reported outside clinic visits
- home – health activities
- decentralized AE/SAE documentation
- eligibility assessments conducted remotely
This takes real time – and regulatory risk rests heavily on the PI.
Budget line:
Decentralized PI Oversight Fee (per patient per month or per remote event)
Telehealth Visit Documentation
Telehealth visits require:
- compliant source documentation
- technical documentation
- audit trails showing who participated
- attestation of procedures that did not occur in person
Budget line:
Telehealth Visit Documentation Fee
Remote IP Management & Reconciliation
Even if the site never touches the drug, they must:
- manage shipping
- reconcile temperature logs
- track IP transit
- document chain of custody
- oversee returns and destruction
- resolve discrepancies they did not create
Budget line:
Remote IP Management Fee (per shipment or per patient)
Additional Administrative Burden
Sites need more hours for:
- new SOPs
- new workflow training
- vendor meetings
- systems access for remote platforms
- oversight documentation for regulatory compliance
- expanded essential document categories
Budget line:
Decentralized Trial Administrative Fee (monthly)
Or
DCT Start – Up Fee (separate + higher than standard)
Scale: The Most Misunderstood Cost Driver
DCT scales in reverse compared to traditional studies.
In onsite studies:
More patients = more work = higher budget.
Fewer patients = lower budget = less work.
In decentralized studies:
More remote components = more work – even if patient numbers stay the same.
More vendors = more oversight.
More devices = more troubleshooting.
More home visits = more coordination.
More remote procedures = more PI oversight.
A site with 20 patients in a DCT trial might perform the equivalent operational burden of 40–60 patients in a traditional trial because the touchpoints multiply, even when visits do not.
Sites must price for this scale shift – or they will drown in unbudgeted labor.
How Sites Should Negotiate DCT Budgets (Strategic Guidance)
- Don’t price DCT with a traditional per – visit model.
Remote work is not visit – based – it is workflow – based. - Require separate DCT start – up fees.
Sites must build DCT SOPs, templates, vendor oversight plans, delegation structures, and tech-readiness infrastructure. - Require monthly administrative fees.
Decentralization adds consistent, ongoing operational burden that cannot be captured in per-visit pricing. - Price PI oversight intentionally and accurately.
A PI cannot oversee remote activity for free – nor should they be expected to. - Tie logistics fees to events rather than patients.
Each remote procedure has separate cost drivers. - Charge for protocol amendments.
DCT amendments often introduce new tech, new consent, new procedures. - Do not allow a bundle of “technology stipends” as all-inclusive.
Call out each component separately to avoid hidden labor.
The Bottom Line
Decentralized trials do not simplify site work; they redistribute it – often into invisible categories that never existed before.
If sites do not budget correctly, they will lose money, burn out staff, and eventually withdraw from the decentralized space altogether.
Sponsors want DCT to succeed. CROs want to deliver on decentralized models.
Sites want to contribute meaningfully without being buried by hidden tasks.
The only path forward is transparency – and budgets that reflect the true operational reality.
DCT doesn’t eliminate the need for sites. It requires stronger, smarter, better supported sites – and budgets that respect the scale, risk, and expertise required to run them well.
For more information or to schedule a budget consultation, email us at info@ridgeresearchsolution.com or contact us here.