Frequently asked questions
The questions, answered with the numbers behind them.
What sponsors, CROs, and feasibility teams ask most often. Where we have a figure, it comes with the population it was drawn from. Where we do not, we say so.
Common questions
Asked by feasibility, clinical operations, and quality.
How is quality kept consistent across community sites?
One quality system, and the same evidence wherever the visit happens. Sites and home visits run under centralized SOPs, with training and delegation tracked in 21 CFR Part 11-compliant systems and electronic source from in-home visits returned to the study site within 24 to 48 hours. In our published post-approval program, 96% of visits fell inside protocol window, and of roughly 3,000 in-home echocardiograms, two were uninterpretable.
What does one clinical trial agreement cover?
Every site in the network and every in-home visit, under one contract and one project manager. New locations join the same operating model and the same CTA on the day they open, so the agreement does not reopen each time the network grows.
Do at-home or hybrid visits add operational burden?
They remove a handoff rather than adding one: a single contract and a single project manager cover both settings, so there is no vendor seam between the site and the home. On turnaround, median intake-to-report fell from 16 days to 7 across nine consecutive months, and 95% of visits were scheduled within two business days. Cost depends on visit mix and assessment design, so we model it per protocol rather than quoting a comparison we cannot show you the working for.
Which therapeutic areas do you support?
Cardio-Metabolic, Infectious Disease and Vaccines, Respiratory, Gastroenterology, Dermatology, Neurology, Allergy and Immunology, and Rheumatology, with named investigators matched to protocol requirements in each. Cardiac imaging and REMS programs are supported through a national sonographer and cardiologist network.
How many community sites do you have, and where are they?
Active sites in nine states, and in-home visits in all 50. Every active site is published with its address; sites in start-up and contracting join the list when they activate.
Who monitors the study?
Monitoring remains CRO-led and risk-based. Our role is to make monitoring efficient: consistent documentation, one project manager, and one point of accountability across every location.
How quickly is source documentation available?
Electronic source data for in-home visits is quality-reviewed and shared securely with the study site within 24 to 48 hours of the visit. Training, delegation, and documentation records are maintained in 21 CFR Part 11-compliant systems and are available for PI and sponsor review.
Is there any data on what patients think of this?
Yes, with its denominator. In a post-approval program surveyed by post between January 2025 and September 2026, 98.9% of respondents rated their overall experience at the top of the scale — 634 of the 641 who answered that question. The response rate was roughly 15%, which we publish because a satisfaction figure without a response rate is not a finding.
Can we see the investigators before we make contact?
We publish the depth rather than the identities: how many board-certified investigators cover each indication, how many trials they have run, and how long they have been in practice. Names, credentials and trial histories are shared directly with sponsors and CROs, so ask and we will send the profiles for the indications you are assessing.
How do you reach patients that research usually misses?
By starting where patients already are — independent pharmacies and community clinics — rather than asking them to travel to an academic centre. The coverage check publishes who lives around each site, from Census data: age, insurance status, and language at home. Those describe the community around a site. They are not patient counts and not enrolment projections.
Still deciding
Send the synopsis, not the whole protocol.
We will come back with the sites and named investigators that fit, the community data behind them, and what we cannot support.