Every X on the schedule, done and billed.
Visits slip and completed procedures go unbilled when the schedule, the source and the invoice live in different places. Kyros Trials connects your visit schedule directly to eSource, regulatory binders, and sponsor invoices, at a published $599 a month.
| Procedure | Screening (Day −28 to −1) | Day 1 (Baseline) | Week 2 (Day 15 ±3) | Week 4 (Day 29 ±3) | Week 8 (Day 57 ±5) | Week 12 (Day 85 ±5) | End of study (Day 99 ±7) |
|---|---|---|---|---|---|---|---|
| Informed consent | X | ||||||
| Eligibility review | X | X | |||||
| Vital signs | X | X | X | X | X | X | X |
| ECG | X | X | X | X | |||
| Safety labs | X | X | X | X | X | ||
| Physical exam | X | X | X | ||||
| Study drug dispensed | X | X | X | ||||
| Adverse event review | X | X | X | X | X | X | |
| Concomitant medications | X | X | X | X | X | X |
Week 4 visit, 204-0012
CARD-204
- Vital signsJM 9:14
- Safety labsJM 9:18
- Physical examAR 9:31
- Study drug dispensedAR 9:32
- Adverse event reviewJM 9:40
- Concomitant medicationsJM 9:41
$950 added to the CARD-204 sponsor invoice.
- In window. Done Day 29, two days before the window closed.
- Exam signed. Sub-investigator signed with password re-entry.
- Nothing to re-key. Source, audit trail and billing written once.
Sample protocol. Not real participant data.
Research, cited: 2025 surveys
The pressure on sites is real.
More systems to navigate. Payments to chase. Protocols to keep up with. Recent site surveys put numbers behind the work your team feels every day.
72%
Too many logins
rated managing multiple logins and passwords as a moderate-to-critical challenge.
Global research-site respondents. Surveyed April–July 2025.
Veeva research-site survey, 2025, pp. 1–263%
Payment uncertainty
rated not being paid on time or according to clinical trial agreements as a moderate-to-critical challenge.
Same global Veeva survey, not a separate study or a percentage of late invoices.
Veeva research-site survey, 2025, pp. 1–237%
More complex trials
of US sites selected clinical trial complexity among their three most pressing issues.
US subgroup of WCG’s 611-site survey. Surveyed July–September 2025.
WCG Site Challenges Report, 2025, pp. 5, 15
Third-party research. Not Kyros Trials customer results.
Both reports are vendor-produced, self-reported surveys, not product comparisons. Veeva does not disclose its completed-response count; 58% of its respondents were US-based. WCG’s sample was 80% US-based. These findings do not measure Kyros Trials performance.
The paper in the room
Most sites run a study in two places at once: the system, and a cabinet. The paper has to answer the same questions the software does. Which version of this consent did she sign? Who was authorized on the study in March?
- 01Signed consent originalsThe page with the signature, and the version it was printed from.
- 02IRB approval lettersApprovals, amendments and continuing review dates.
- 03Delegation logWho was authorized to do what, and from which date.
- 04Training recordsCVs and GCP and protocol training, with expiry dates.
- 05Lab and vendor printoutsLab reports, vendor forms, and the paperwork behind a result.
- 06Monitor copiesThe printouts a monitor reviews, signs and takes or leaves.
- 07Deviation paperworkThe form, the signature and the corrective action.
- 08Sponsor correspondenceBudget pages, purchase orders, and the email nobody printed.
Move across the tray to pull a folder.
Kyros Trials keeps the versioned record for all of it: IRB approvals, the delegation log and training records, each with a current version and a history, and every change carries a reason and a signature. Paper stays where it is useful. It just stops being the only copy.
Friday afternoon, before and after
Friday afternoon, before and after
Five chores every site runs at the end of the week, done the paper-and-spreadsheet way and the Kyros Trials way. The difference is whether the visit schedule, the source entry and the sponsor invoice are three separate things or one record.
- Billing the week
- With paper and spreadsheets: Read every visit note and copy procedures into an invoice spreadsheet.
- In Kyros Trials: Completed procedures are already on the unbilled list, grouped by sponsor.
- Next week's windows
- With paper and spreadsheets: Count days from Day 1 on a calendar for each participant.
- In Kyros Trials: Windows are worked out from Day 1 and shown on Today.
- Missing signatures
- With paper and spreadsheets: Flag pages with sticky notes and wait for the investigator.
- In Kyros Trials: Unsigned items sit in the investigator's queue.
- Filing new documents
- With paper and spreadsheets: Print, sign, file in the binder and update the log.
- In Kyros Trials: Upload once to the binder, with version and signature history.
- Monitor visit prep
- With paper and spreadsheets: Pull charts and copy pages for the monitor.
- In Kyros Trials: Give the monitor access to their study and dates.
| The chore | With paper and spreadsheets | In Kyros Trials |
|---|---|---|
| Billing the week | Read every visit note and copy procedures into an invoice spreadsheet. | Completed procedures are already on the unbilled list, grouped by sponsor. |
| Next week's windows | Count days from Day 1 on a calendar for each participant. | Windows are worked out from Day 1 and shown on Today. |
| Missing signatures | Flag pages with sticky notes and wait for the investigator. | Unsigned items sit in the investigator's queue. |
| Filing new documents | Print, sign, file in the binder and update the log. | Upload once to the binder, with version and signature history. |
| Monitor visit prep | Pull charts and copy pages for the monitor. | Give the monitor access to their study and dates. |
A coordinator's Tuesday
Five moments from one day at a site, in one system. Pick a time to see the screen.
See today's visits and which windows close this week
Consent a new participant on the current IRB-approved version
Enter source at the visit. The monitor can review it the same day.
Each completed procedure with a fee in your clinical trial agreement becomes an unbilled item. Source and audit history stay linked to the visit; the fee accrues on its configured trigger. Pick a procedure from the sample Week 4 visit.
Vital signs, Week 4, 204-0012
Window Oct 24 to 30. Done Oct 27, in window.
- Source
- BP 128/82, HR 71, temp 98.4 °F. All fields complete.
- Audit trail
- Entered by JM, Oct 27 9:14 AM. Server time stamp.
- Sponsor billing
- $75 unbilled item added to the CARD-204 fee schedule.
Sample protocol. Not real participant data.
Sign off as investigator with re-authentication
Send the sponsor an invoice built from today's completed procedures
Everything a site runs on
Site CTMS
Read about the CTMSStudies, participants, visit windows and one calendar for the whole site.
eSource and eCRF
Read about eSourceSource entered at the visit, with queries on the field and SDV status.
eRegulatory binder
Read about the binderIRB approvals, delegation log and training records in one versioned binder.
eConsent
Read about eConsentConsent on the current approved version, with re-consent after amendments.
Recruiting and prescreen
Read about recruitingA prescreen for each study, with your staff deciding who comes in for screening.
Sponsor invoicing
Read about invoicingCompleted procedures build the sponsor invoice, tracked until it is paid.
Monitoring
Included in every planMonitors review source remotely with study-scoped access.
Data export
Included in every planExport to CDISC ODM 1.3.2 and SDTM-aligned CSV, plus PDF and CSV of everything.
Pricing
No onboarding fee and no annual contract. The founding Site offer is $399 a month for twelve months under its published terms. Accounts are by invitation and start with a 20-minute demo. Full pricing and terms
Starter
$299
per month
Billed monthly
- 1 location
- Up to 8 active studies
- Core site workflows
- Unlimited users
Site
Most sites choose this$599
per month
Billed monthly
- 1 location
- Unlimited studies
- Core site workflows, plus AI drafting, prescreen and assistant
- Unlimited users
Network
$499
per location, per month
Billed monthly
- 2+ locations
- Everything in Site
- One company across all locations
- Per-location billing
- Shared fee schedules
Records you can stand behind
What the system does for Part 11, where AI helps and where it stops, and what happens to your data.
How Kyros Trials supports 21 CFR Part 11 controls
Supports 21 CFR Part 11 controls (audit trail, e-signatures with re-authentication, access controls). Compliance depends on how each site validates and uses the system.
Read the full details
Part 11 is shared work: the system has to do some things and your site has to do others. This splits the eight rules that come up most, so you can see which parts arrive with Kyros Trials and which stay yours.
- 11.10(a) Validation
- What Kyros Trials does: Validation documentation for the system (in progress; available to customers under NDA)
- What your site still owns: Your risk-based validation and SOPs
- 11.10(d) Limited access
- What Kyros Trials does: Role-based access within your company, invite-only accounts
- What your site still owns: Who you invite and which roles they get
- 11.10(e) Audit trail
- What Kyros Trials does: Computer-generated, time-stamped audit trail of creates, changes and voids, with user, before/after values and reason
- What your site still owns: Reviewing audit trails per your SOPs
- 11.10(f) and (g) Operational and authority checks
- What Kyros Trials does: Locked records, investigator-only sign-off, delegation log
- What your site still owns: Keeping delegation current
- 11.50 Signature manifestation
- What Kyros Trials does: Printed name, server date/time and meaning on every signature
- What your site still owns: Training signers on what each meaning commits them to
- 11.70 Signature and record linking
- What Kyros Trials does: Signatures bound to the record they sign
- What your site still owns: Not sharing records outside the system as signed copies
- 11.200 E-signature components
- What Kyros Trials does: Credentials re-entered at signing
- What your site still owns: Making sure people sign only for themselves
- 11.300 Credential controls
- What Kyros Trials does: Password rules, lockout, optional two-factor sign-in
- What your site still owns: Your 11.100(c) certification letter to FDA
No software meets Part 11 on its own. Compliance depends on how each site validates and uses the system.
Monitoring day without staging a binder
Give the study monitor their own sign-in, limited to the study they monitor and to the dates you set.
They review source, signatures and the regulatory binder on screen and raise queries where they find them. Your coordinators answer in the same place.
Monitor access, CARD-204
Until Nov 14
Can
- Open source and signed forms
- Review the regulatory binder
- Raise and close queries
Cannot
- Edit or sign records
- See other studies
- Use access after the end date
How AI is used in Kyros Trials
A first draft, not the final word. Your staff stay responsible for what is approved and used.
Decisions stay with your team
- Never decides eligibility
- Never signs
- Never sends on its own
Read the full details
Assistive AI. Human accountability.
From first draft to reviewed record
AI prepares a draft
AI writes first drafts of routine documents, such as adverse event narratives and sponsor emails.
Your staff review and approve
A named staff member reviews, edits and approves every draft before it is used.
The work is logged
Every AI request and output is logged with the model version and the approving user.
Your data stays yours
We never sell your data. Not to advertisers, not to data brokers, not to anyone.
Your data is never used to train AI models, ours or anyone else's.
Read the full details
- We never sell your data. Not to advertisers, not to data brokers, not to anyone.
- Your data is never used to train AI models, ours or anyone else's.
- Kyros Trials staff don't access your records unless you ask us for support or the law requires it. That access is limited to named people and recorded.
- You can export everything, including audit trails and signatures, at any time.
Your records. A reviewed transition.
Switching in three steps
Bring your existing records
Send us an export from your current system, or your paper binders.
Review the mapping
We map studies, participants, visits and documents, and you check a sample.
Move with confidence
Go live with your team. Your old system stays read-only until you're satisfied.
Migration is free on every plan.
How migration worksYour export, mapped to Kyros Trials
Familiar columns. Connected records.
Participant column mapping
Sample export| In your export | In Kyros Trials |
|---|---|
| subject id | Subject number |
| first name | First name |
| last name | Last name |
| date of birth | Date of birth |
| study | Study protocol number |
| consent date | Consent date |
| day 1 | Day 1 date |
| subject status | Status |
You review before saving. Unknown studies, unknown visit codes, duplicate subjects and bad dates are flagged by row.
Product names belong to their owners.
Who is Kyros Trials for?
Independent US clinical research sites and small site networks that run sponsor-funded studies. Kyros Trials is not built for sponsors or CROs.
What does it cost?
Starter is $299, Site is $599 and Network is $499 per location per month. There is no onboarding fee and no annual contract. See pricing.
Does Kyros Trials meet 21 CFR Part 11?
Kyros Trials supports 21 CFR Part 11 controls: a time-stamped audit trail of every change, with user, before/after values and reason; e-signatures with re-authentication; and role-based access. Compliance depends on how each site validates and uses the system.
How does migration work?
Send us an export from your current system, or your paper binders. We map studies, participants, visits and documents, you check a sample, and then you go live. Migration is free on every plan.
Where is data hosted and will you sign a BAA?
Kyros Trials will sign a BAA once our HIPAA-eligible hosting and AI infrastructure are fully in place. Contact us for the current status.
Can we export our data and leave?
Yes. Export everything, including audit trails and signatures, at any time. Plans are month-to-month.
See your own protocol in Kyros Trials.
Walk through your visit schedule, source records and sponsor billing with our team.
Week 4 Visit
Sample record- Window
- Day 29 ±3
- Source
- Vital signs, safety labs and examination recorded
- Review
- Named investigator signature required
- Billing
- Completed procedures linked to the sponsor invoice