Enroll faster and stay audit-ready without adding staff.
AI systems for research sites in metro Detroit and across Michigan: first contact with a referral in seconds, prescreens run and visits booked, the protocol answered from its own pages, the regulatory binder watched, source documents read with a person confirming, and the numbers sponsors ask for in one view. Built beside the CTMS, EDC and scheduling you already run, never in their place.
Talk to usIn short
Eleven systems around a study, none of them a system of record: the referral answered before a coordinator sees it, the protocol that answers itself, the binder that warns six weeks out, the paper form read with a person confirming, and one page that shows every study against its target.
- First contact with a referral in seconds, after hours included
- Protocol and SOP answers with the section cited
- Every expiring credential reminded before it lapses
- Source documents read, every value confirmed by a person
Why the first call decides the study
One site in nine never enrolls a participant. The difference is usually the first call.
Tufts looked at nearly 16,000 sites across 151 trials. One in nine never enrolled anyone; more than a third under-enrolled. The referrals were there. The site was in a visit when they arrived, and by morning they had answered someone else.
We build the systems around the study that nobody has hands for: the referral answered in seconds with the IRB-approved prescreen, the visit booked and reminded, the protocol answered from its own pages, the binder watched, the paper read. Each one sits beside the CTMS, the EDC and the binder, never in their place, and the study team keeps every decision that is theirs.
Illustrative. The script and the questions are the study's own, approved by the IRB; the point is the elapsed column.
- 11%
- of sites in a typical trial fail to enroll a single participant
- 37%
- under-enroll, across nearly 16,000 sites in 151 Phase II and III trials
Tufts Center for the Study of Drug Development, Impact Report, 2013.
Eleven systems
Built around the study, never as a system of record
01 of 11Speed-to-Lead Screening and Scheduling
First contact with an inbound referral in seconds, by text or voice, whether it came from an ad, the study website, ClinicalTrials.gov or a call. The IRB-approved prescreen for that study is run, the answers captured, clear non-fits let down kindly, and qualified candidates booked straight into the site's scheduling system with confirmation and reminders. Coordinators receive completed prescreens rather than names to chase. It works after hours, where a large share of inquiries arrive, and reports time to first contact, contact rate, prescreen completion and show rate per campaign, so recruitment spend is judged on qualified visits rather than clicks.
- Works with
- Study websiteClinicalTrials.govYour phone systemYour scheduling system
- Never
- Decides eligibility. It runs the IRB-approved questions and records the answers; the study team decides.
02 of 11Protocol and SOP Assistant
A conversational assistant trained on the site's own documents: active protocols and amendments, SOPs, work instructions, manuals and training materials. Staff ask in plain language and get the answer with the document and section cited: visit window boundaries, inclusion and exclusion criteria, kit and sample handling, deviation reporting, what changed between versions. It is anchored to the current approved version rather than someone's memory of the last one, and it reads documents only. It never touches participant data, so it sits outside the regulated systems entirely.
- Works with
- Protocols and amendmentsSOPs and work instructionsTraining materials
- Never
- Touches participant data or gives clinical judgement. It reads documents only.
03 of 11Feasibility Response Generator
Sponsor and CRO feasibility questionnaires drafted from a maintained site profile: PI experience and therapeutic areas, staffing, equipment and certifications, laboratory and pharmacy capabilities, population, historical enrollment by indication, past study performance. A new questionnaire produces a complete draft for review instead of a blank form, so responses go back in hours rather than days, and because the same questions recur across sponsors, accuracy improves as the profile matures. The site stops losing awards to slow turnaround.
- Works with
- Site profileEnrollment historySponsor and CRO questionnaires
- Never
- Sends anything unreviewed. Every draft goes back through the PI or the site director.
04 of 11Regulatory Document Tracking
A monitoring layer over the regulatory binder. Every expiration-dated item across every study and staff member, CVs, medical licenses, GCP and protocol training, financial disclosures, delegation of authority logs, 1572s, lab certifications and normal ranges, with escalating reminders before anything lapses. Missing documents flagged per study and per person, and the required packet assembled when a new site or staff member is added to a protocol. Audit readiness without a person reconciling folders, and no lapsed credential discovered during a monitoring visit.
- Works with
- Regulatory binderTraining recordsDelegation logsLab certifications
- Never
- Replaces the binder. It reads dates; the binder stays the record.
05 of 11Source Document Digitization
Completed paper forms, scanned or photographed, handwriting included, read into structured records by the meaning of each field rather than its position, so layout variation across form types is tolerated. Every extracted value is shown beside its source image with a confidence indicator, and a person confirms before anything is committed. A transcription accelerator with verification, never an autonomous system of record, which is what keeps it inside data integrity expectations while removing most of the keystrokes.
- Works with
- Scanned and photographed formsHandwritingYour EDC, through its own interface
- Never
- Commits a value nobody confirmed. It is a transcription accelerator, not a system of record.
06 of 11Performance Dashboards
Enrollment and operations from the CTMS, EDC and scheduling systems in one view: screening and randomization against target by study and by site, screen-fail reasons, time from referral to consent, visit completion and no-show rates, query volume and resolution time, workload and throughput per coordinator. Scorecards give staff consistent, visible measures instead of impressions, and leadership sees which study is behind early enough to act.
- Works with
- CTMSEDCScheduling system
- Never
- Writes to any of them. It reads, and the numbers stay where they came from.
07 of 11Visit Adherence Messaging
Reminders and confirmations across the visit lifecycle by text, email or voice, with visit-specific preparation such as fasting or medication holds, confirmations collected, non-responses flagged for a coordinator to call, and rescheduling outreach after a missed visit. A missed visit is a deviation and lost revenue, and most are preventable with contact nobody has time to make by hand.
- Works with
- Scheduling systemText, email and voiceIRB-approved wording
- Never
- Changes a visit window. Rescheduling stays inside the protocol, and a coordinator sees every non-response.
08 of 11Back-Office Request Portals
Procurement, expense reimbursement and timecard corrections as simple submission forms: routed to the right approver, status visible to the requester, stalled approvals reminded, and a complete record of what was requested, approved and paid. Timecards get automatic discrepancy detection, missing punches, overlapping entries and hours that conflict with scheduled coverage, before payroll closes. It replaces the email threads and spreadsheets only one person understands.
- Works with
- Approvers by rolePayroll cut-offYour accounting
- Never
- Approves anything itself. It routes, reminds and records; people approve.
09 of 11Study Startup Tracker
Every activation milestone in one place: budget and contract rounds, IRB submission and approval, the 1572 and delegation log, training, the site initiation visit, the first screen. Owners, dates and what is blocked, with reminders ahead of each date and a weekly status line for the sponsor's contact if you want one, so the site is ready when the study opens rather than three weeks after.
- Works with
- Contracts and budgetsIRB submissionsSite initiation visit
- Never
- Submits to an IRB or signs a contract. It tracks the dates; the people do the work.
10 of 11Recruitment Campaign Management
Study advertising run the way the rest of a business's marketing is: IRB-approved creative only, targeted to the counties and communities the protocol needs, tracked from the click to the prescreen to the qualified visit, and reported per campaign in visits rather than impressions. Budget moves toward the sources that produce qualified candidates and away from the ones that produce clicks.
- Works with
- Google and Meta adsYour study websiteThe prescreen system
- Never
- Runs creative the IRB has not approved, or targets anyone by health status.
11 of 11Monitoring Visit Preparation
Before each monitoring visit, the checklist assembled from the monitoring plan: the source expected for the visits since the last one, queries still open, regulatory items due, deviations to be logged. What is missing is listed for the coordinator with time to fix it, so the visit confirms what is there rather than discovering what is not.
- Works with
- Monitoring planCTMSRegulatory tracker
- Never
- Alters source or closes a query. It lists what is missing; the coordinator fixes it.
Audit readiness
The credential that lapsed was found by the monitor. Now it is found six weeks earlier.
A regulatory binder is hundreds of dated documents kept by a person who also runs visits. The CV that expired last month is not negligence; it is the sixth folder on a Friday. A monitoring visit is the wrong place to learn it.
The tracker reads every date across every study and every staff member, reminds the right person at sixty, thirty and seven days, flags what is missing per protocol, and assembles the packet when a new person or a new site is added. The binder stays the record. The board is how you know it is complete before anyone asks.
Illustrative. The names are invented. The board reads the dates; the people renew the documents, six weeks before a monitor would have asked.
Fitted work
What comes up here, specifically
The research corridor
Metro Detroit runs some of the busiest trial sites in the country, the hospital systems and the independent sites around them, all drawing on the same population. Two sites can be recruiting for the same indication a few miles apart. The one that answers a referral at 9:40 pm is the one that gets the participant.
The January visit
A winter visit across Oakland or Wayne County is the one most likely to be missed. The reminder carries the parking and the weather plan, a confirmation is asked for, and the reschedule is offered inside the window before it becomes a deviation.
Prescreening in Arabic and Spanish
Dearborn, Hamtramck and southwest Detroit are under-represented in most protocols. Prescreens run in Arabic and Spanish from the IRB-approved translations, and the coordinator who follows up is told which language to use.
The sponsor two time zones away
A feasibility questionnaire that lands at 4 pm from a sponsor in California is drafted from the site profile that evening and reviewed in the morning, not started next week. Turnaround is the part of feasibility a site controls.
Getting there
Audit, pick the first system, build beside the record, verify, run
- 01
Audit the site's week
Where the referrals arrive and how long they wait, what the coordinators retype, what the binder is missing, what the sponsor's last questionnaire took. Measured, not guessed.
- 02
Pick the first system
Usually the referral response or the binder, because both show a result inside a month and neither touches a system of record.
- 03
Build beside the systems of record
On accounts the site owns, connected to the CTMS, EDC and scheduling through their own integrations, with every write logged and every script the IRB has approved used verbatim.
- 04
Verify with your QA
Test scripts run with your staff, the documentation written for your quality file, access set by role. Nothing goes live because a build finished.
- 05
Run it
Monitored so silence is an alert, repaired when a vendor changes an interface, reported monthly in the numbers a sponsor asks for.
Scope
What we do not build
A system of record
The EDC, the CTMS and the regulatory binder stay the systems of record. What we build reads from them and writes to them only through their own integrations, with the audit trail intact.
Eligibility decisions
The prescreen runs the IRB-approved questions and records the answers. Whether someone is eligible is decided by the study team, on the protocol, at the screening visit.
Consent
No system here obtains, explains or documents consent. It books the visit at which consent happens and reminds the participant to come.
Compliance certification
We do not validate your systems or certify Part 11, GCP or HIPAA compliance. We build to the standards, document what we built, and hand the documentation to your QA.
Clinical judgement
The protocol assistant answers what the protocol says, with the section cited. It never says what to do with a participant.
Training on your participants
Nothing about a participant is used to train anything. Where a system touches identifiable information it does so under a Business Associate Agreement, in accounts the site owns.
Questions
Asked and answered
Does this touch protected health information?
Some of it does, the referral response, the visit messaging and the digitization, and those run under a Business Associate Agreement in accounts the site owns, with access by role and every action logged. The protocol assistant, the feasibility generator, the binder tracker and the request portals read documents and dates, not participants, and sit outside the regulated systems.
Is the source digitization Part 11 compliant?
It is built as a transcription accelerator with human verification, not as a validated system of record: every value is confirmed by a person against the source image before it is committed to your EDC through the EDC's own interface, and the audit trail lives there. We document the build for your quality file; validation of your systems remains yours.
Who approves the prescreen questions and the messages?
Your IRB, as they do now. The system runs the approved questions and scripts verbatim, in the approved languages, and changes to any of them go through your amendment process before they are loaded.
Does it work with our CTMS, EDC and scheduling system?
It is built beside the systems you already run, through their own integrations, and it never replaces them. We do not name vendors until we have connected one for a client; tell us what you run and we will say exactly how it connects and what it cannot do.
Who owns the site profile, the documents and the data?
You do. Everything runs in accounts the site owns, the documentation is written for whoever comes next, and if we stop working together the systems keep running where they are.
We already use a recruitment vendor. Does this replace them?
No. It answers what they send within seconds instead of the next morning, and it measures every source, the vendor included, in qualified visits rather than referrals. Most sites find the measurement changes where the recruitment budget goes.
Goes with
The general pages these are built from
- Every lead gets an answer in under a minute.Lead Follow-Up Automation
- A schedule that fills itself and keeps itself full.Appointment Scheduling and Reminder Automation
- The paperwork handles itself.Back Office Automation
- Ask it instead of interrupting the owner.Internal Knowledge Assistant
- Which of the things you pay for brought the job.Analytics and Conversion Tracking
Tell us about your enrolling studies.
How many are open, where the referrals come from, and how long the last one waited for a reply. We will tell you what the first system would be, what it would change in a month, and what your QA would need to see before it went live.
Talk to us