Frequently asked questions

The platform is in preview. Selective activity plans, linking an existing site enrollment, a unified weekly plan, flexible visit options, and tracked routine help requests are in development and not yet released. The feature catalog separates this work from the product preview.

TrialPilot is clinical trial software connecting a participant app with a researcher workspace. The preview supports study setup, enrollment, assessments, supported wearable data, monitoring, and data review. Availability depends on the study and app version.

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.

There are three ways into a study on TrialPilot:

• The study ships it. Some interventional studies send the investigational treatment straight to your door, with tracked delivery and receipt confirmation. The protocol sets the remaining activities, monitoring, and results process.
• You and your clinician bring it. Some studies observe a therapeutic you're already taking (or starting) under your own clinician's care. Eligibility and care arrangements depend on the study.
• You run a self-trial. You structure a personal experiment around a question and repeated measures. Results remain observational and do not establish treatment effectiveness.

Some studies are placebo-controlled, some are observational, and some are n = 1 — the informed consent (or self-trial setup) always tells you exactly which kind you're in.

Possibly. Eligibility depends on the study’s criteria and screening process. An observational study may collect information about care you already receive. Review the consent and speak with your clinician and study team before making any treatment changes.

Only in studies designed that way, and never as a surprise. In a placebo-controlled study you're told before you consent that you may receive a placebo and what the chances are — that comparison is what makes the result trustworthy. Observational studies never use placebos (you stay on your own treatment), and in a self-trial you always know what you're taking.

Review the study’s consent information for any costs, reimbursements, equipment arrangements, and compensation. These are study-specific terms; joining the patient list does not establish them.

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.

Some study activities can happen at home, while others require a site visit, equipment, or supervision. Check the study’s location requirements and visit arrangements before enrolling.

Requirements depend on the study. Supported browser workflows can cover compatible studies; wearable sync and guided physical assessments require the native app. Confirm required equipment, availability, and any costs with the study team. See the browser participation guide.

The study’s schedule sets the commitment: this may involve a bounded questionnaire or specimen journey, repeated check-ins, or visits. Review the expected frequency, duration, and required activities before consent.

TrialPilot separates participant identity from coordinator-facing study data, applies access controls, and records audit history. Your study consent explains what is collected, how it is used, and who may access it. See our privacy policy for more detail.

Access depends on the study, your consent, and the role of the people providing the service. Review your study consent and our privacy policy for how information is used and shared. Contact your study team with questions about access to study data.

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.

Personal trends, individual test results, and overall study findings are different. Your study team explains which it plans to share, when, and under what conditions. Taking part does not guarantee personal answers or a diagnosis. You can review those plans before deciding whether to join.

TrialPilot supports remote participation. Some studies include local services, such as a nearby blood draw. Review service coverage, eligibility, required activities, practical support, and the time involved before joining. Choosing discovery filters does not determine eligibility.

Check the completion channels offered for each activity. SMS and email reminders do not mean an assessment can be completed by reply. The study team explains which supported channels are available.

Email support@trialpilot.app for help with the app, or visit our Support page. For questions about your treatment or study tasks, contact your study 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.

Interventional Phase 1–4 trials with direct-to-patient shipping of the investigational product (including randomized, placebo-controlled designs), observational studies and registries that capture real-world data on therapeutics participants already take under their own clinician's care, natural-history studies, and participant-led n-of-1 self-trials. We're especially well-suited for trials that have struggled with enrollment under traditional site-based models.

The preview includes consent workflows, audit trails, data controls, and supported exports. These tools do not certify compliance with HIPAA, 21 CFR Part 11, or ICH-GCP. Sponsors and sites must assess their intended use, system qualification, contracts, approvals, and operating procedures.

Sponsors define eligibility criteria and share study links or recruitment campaigns. Participants complete the applicable screening and consent steps; authorized staff perform the required reviews. Timing depends on the protocol and approvals.

Remote activities can reduce travel barriers for some participants. A representative cohort still depends on study design, eligibility, recruitment, accessibility, and the populations reached. We do not yet claim measured enrollment-diversity outcomes for TrialPilot.

External EDC, eCOA, EHR, and laboratory connections require separate scoping and are not included as ready-made connectors in the preview. TrialPilot supports its own managed dataset and CDISC SDTM / define.xml generation; confirm coverage and validate outputs for your study.

Participants can report safety concerns and study teams can review events, track escalations, and record reporting obligations. A coding review workflow exists, but licensed MedDRA and WHODrug dictionaries are not connected in the preview. Response follows the site’s procedures; this is not an emergency monitoring service.

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.

Academic and investigator-led teams are welcome to discuss the pilot program. We assess the protocol, required workflows, support needs, and commercial arrangements together.

Timing depends on protocol fit, study configuration, approvals, system qualification, training, and operational readiness. We scope those steps with each pilot partner rather than promise a standard launch time.

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 guidance discusses using decentralized elements to make participation more convenient. Appropriate choices depend on the population, investigational product, and assessments. Guidance describes considerations for trial design; it does not establish benefits for every study.

Use the guidance when planning remote activities, responsibilities, and oversight. Sponsors and investigators must assess their own protocol, technology, procedures, and applicable requirements. TrialPilot’s features do not by themselves establish regulatory compliance.

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 later extended the comment period to June 29, 2026. Its April announcement described planned selection milestones; consult the linked FDA notice for the agency’s updates.

The initiative explores earlier sharing of study signals with the agency. It does not guarantee faster access to a treatment or replace a participant’s study-specific safety and consent arrangements.

Participation depends on the agency’s program criteria and agreed technical arrangements. A platform collecting data continuously does not automatically have an FDA submission pathway or qualify a sponsor for a pilot.

TrialPilot provides participant data capture, study review workflows, and supported exports. We do not claim participation in the FDA RTCT pilot, an FDA connection, or an established real-time submission pathway. Any such use would require separate technical and regulatory assessment.

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.

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