Frequently asked questions

TrialPilot is an AI-powered decentralized clinical trial platform. We help researchers run faster, more inclusive trials, and we help patients participate in research from anywhere — without needing to live near a major research center.

A decentralized clinical trial (DCT) uses technology — mobile apps, wearables, telehealth, and at-home visits — to bring the trial to the patient instead of requiring frequent travel to a study site. Some studies are fully remote; others are “hybrid” and mix in-person visits with remote data collection.

No. TrialPilot is a software platform that supports clinical research. We don't provide medical care or medical advice. Care during a trial is provided by the study's investigators and clinical staff.

We're currently launching in the United States, with plans to expand internationally as we work through additional regulatory frameworks. Trial availability depends on each study's protocol and the regions its sponsor has approved.

Start by joining our patient waitlist. We'll let you know when trials become available that may match your profile and connect you with the research team. Final eligibility is determined by the study investigators during a screening process.

Every trial has its own eligibility criteria (inclusion and exclusion rules) set by the sponsor and reviewed by an Institutional Review Board. When a trial opens, we'll show you the criteria up front and walk you through screening so you can see whether you qualify before committing further time.

Participating in a clinical trial through TrialPilot is free for patients. Many trials also reimburse certain costs (travel, time, devices) — details vary by study and are described in the informed consent document.

Some trials offer compensation for participation; others don't. When compensation is offered, the amount and schedule are documented in the informed consent before you enroll, never as a surprise.

That's exactly the problem we're solving. Most TrialPilot studies are designed to work from home using our patient app, wearables, and telehealth visits. Some studies may still require occasional in-person visits — we'll be clear about that before you enroll.

A modern smartphone (iOS or Android) is enough for most studies. If a trial requires a wearable, blood pressure cuff, or other device, the sponsor ships it to you at no cost. The patient app walks you through setup.

It varies by study, but most trials involve a few minutes a day for check-ins or device readings, plus periodic telehealth visits. The time commitment is documented up front before you consent.

Yes. We follow industry standards including encryption at rest and in transit, strict access controls, and audit logging in compliance with HIPAA and FDA 21 CFR Part 11. Health data is shared with research teams only with your explicit consent.

Only the study team you consent to share with, and only the data needed for that study. We never sell your data. You can review and revoke consent at any time from the patient app.

Yes. You may withdraw from a clinical trial at any time, for any reason, without affecting your regular medical care. Withdrawal procedures are described in the informed consent document for each study.

Report it through the patient app's symptom tracker and contact your study coordinator using the contact information in your enrollment materials. For medical emergencies, call 911 or go to the nearest emergency room first — your safety comes before any trial protocol.

Informed consent is a process (and a document) that explains what a study involves, the risks, the benefits, your rights, and what data will be collected. You sign it electronically before joining and can re-read it in the patient app at any time.

Yes. We send participants a plain-language summary when results are available, and we link out to the published study so you can read the full version if you're interested.

Open the side menu in the patient app and tap Help & support, or visit our Support page. Either route reaches the same team.

Yes. We work with academic researchers, pharma sponsors, and biotech teams to design and run decentralized and hybrid trials. Join our researcher waitlist and we'll be in touch.

Observational studies, registries, natural-history studies, and interventional Phase 1–4 trials where remote data collection is appropriate. We're especially well-suited for trials that have struggled with enrollment under traditional site-based models.

Yes. Our platform is designed to meet FDA 21 CFR Part 11 (electronic records and signatures), ICH-GCP, and HIPAA requirements. We support IRB-approved e-consent, audit trails, and the documentation sponsors need for regulatory submissions.

Sponsors define eligibility criteria; we match against the patient community and direct outreach. Patients complete e-consent and screening in the app. Investigators confirm enrollment. The whole loop typically runs in days, not months.

Decentralized trials reach patients who can't travel to a major research center — rural patients, patients with disabilities, caregivers, and underrepresented communities. Sponsors using TrialPilot consistently see broader, more representative enrollment.

Yes. We support integrations with common electronic data capture (EDC) and electronic clinical outcome assessment (eCOA) systems, and we can export data in CDISC SDTM format for regulatory submission.

Patients report symptoms through the app; the platform flags potential adverse events for clinician review and supports MedDRA coding. Investigators can configure escalation rules so urgent reports surface immediately.

Pricing depends on study size, complexity, and required integrations. Email jon@xaiushq.com with a brief description of your protocol and we'll put together a quote.

Yes. We have lighter-weight tooling for academic and investigator-initiated trials, including pricing aligned to non-commercial budgets.

A typical decentralized trial on TrialPilot can move from protocol to first-patient-in within weeks rather than months, depending on IRB review timelines and sponsor readiness.

Yes. In September 2024 the FDA finalized “Conducting Clinical Trials With Decentralized Elements”, a Guidance for Industry, Investigators, and Other Interested Parties covering drugs, biological products, and devices. It replaced the 2023 draft DCT guidance and is the FDA's authoritative position on how to run trials with remote elements. Read the full PDF.

Trial-related activities that occur at locations other than a traditional clinical trial site — for example, telehealth visits, in-home visits by trial personnel, visits with the participant's local healthcare provider, or remote data collection from connected devices. A decentralized clinical trial (DCT) is one that includes any of these elements.

The document gives recommendations on:

• Designing a trial with decentralized elements (fully remote vs. hybrid)
• Remote informed consent, with continued IRB oversight
• Roles and responsibilities of sponsors, investigators, and remote trial personnel
• Determining whether an investigational product is appropriate for a DCT, and how to package and ship it
• Use of digital health technologies (e.g. wearables, apps) for endpoint capture
• Safety monitoring and adverse event reporting in a remote setting
• Software used in DCTs and considerations under 21 CFR Part 11

The FDA's view is that decentralized elements can “enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse patient populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility.” In other words: better trials for patients, faster answers for science, and broader, more representative data for regulators.

Decentralized elements are no longer experimental from a regulatory standpoint — the FDA has now formally described how to use them in a way that satisfies the same scientific and safety standards as a traditional trial. Sponsors can adopt remote consent, telehealth visits, and connected-device data capture with confidence, provided their processes follow the recommendations in the guidance. TrialPilot is built to those recommendations end-to-end.

In 2026 the FDA announced major steps toward real-time clinical trials — trials that report endpoints and data signals to the agency as they happen, rather than waiting for traditional end-of-study analysis. The goal is faster regulatory review, better safety monitoring, and more efficient use of trial data using modern AI and data infrastructure.

The announcement included two main pieces:

• Two proof-of-concept real-time trials — one led by AstraZeneca (the Phase 2 TRAVERSE study in treatment-naïve mantle cell lymphoma, with MD Anderson and the University of Pennsylvania) and one led by Amgen — that will stream endpoints and data signals to the FDA in real time.
• A Request for Information (RFI) on a broader RTCT pilot program. The FDA is accepting comments through May 29, 2026, plans to release final selection criteria in July 2026, and intends to complete pilot selections in August 2026.

Real-time trials can shorten the time between data collection and regulatory decisions, which means promising treatments can reach patients faster. Real-time safety monitoring also means problems are spotted earlier — which is good for the patients in the trial and for everyone who comes after them.

The FDA is signalling that the agency is ready to receive trial data on a continuous basis, not just in periodic submissions. Sponsors and sites that can produce clean, real-time, audit-ready data are well-positioned to participate in the pilot and in future RTCT programs — and to benefit from faster review cycles.

TrialPilot was built for exactly this model. Our decentralized infrastructure already collects data continuously from patients, devices, and sites; everything is timestamped, auditable under 21 CFR Part 11, and designed for streaming export. If you're considering applying to the FDA's pilot program or building toward real-time-capable infrastructure for a future submission, get in touch — we'd love to help.

You do. Your personal health data is yours. We process it on behalf of the research teams you consent to share with, and only for the purposes you agree to.

No. We do not sell personal information. See our Privacy Policy for full details on how we handle data.

Data collected up to your withdrawal date may be retained as required by regulation and the study protocol (this is standard across clinical research). You can request deletion of identifiers we hold for marketing or account purposes at any time.

If you didn't find what you were looking for, our team is happy to help.