A medtech startup usually needs its first clinical evidence before it has a clinical operations department. Capture lets a small team build forms, consent participants, collect patient-reported outcomes and keep an audit trail in one system, starting in a free sandbox and paying only when the study goes live.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Draft the investigational plan
Visits, endpoints, safety reporting
Build forms and consent
AI draft, human review
Rehearse in the sandbox
Practice cases, queries, export
Ethics and site approvals
Blank eCRF PDF for the committee
Enrol first participants
Live phase begins
What a medtech startup needs from clinical trial software
The startup stage
Medtech startups commonly run on a handful of people and a runway measured in quarters. The first clinical study might be a small first-in-human or early feasibility study with a few sites. Procurement of an enterprise EDC usually assumes a clinical operations team, a statement of work and months of lead time. For a startup the cost is as much the calendar as the money: a month lost to setup is a month of runway.
The cheaper alternative, a spreadsheet or general survey form, fails later and at a worse moment. A first-in-human study will be examined closely by ethics committees, by clinical sites, by investors in due diligence and eventually by regulators. An entry that cannot be traced, a consent not linked to its document version, or an adverse event kept in an email thread are all avoidable. See also our clinical trial software for startup biotech and clinical trial tools for startups pages, which cover the same constraint from the drug side.
Capture is designed for this stage. You sign up, build in the sandbox, test every feature with fake participants and only start paying when you go live. There is no enterprise sales call needed to begin. For teams who want a walk-through anyway, the demo is open.
Device specifics
A device study’s forms revolve around the procedure and the device. Record which unit was used, who used it, when and with what result, and keep problems with the device separate from adverse events in participants. The medical device clinical trials page gives the general use case, and the feasibility studies page covers small first studies.
Startups often rely on patient-reported outcomes and connected device data to show benefit. Questionnaires open from a link in the participant’s phone browser, with reminders, so there is no app to build or maintain. Where a participant’s own wearable matters, Capture supports connecting the account through the vendor’s sign-in and syncing automatically; see the wearable device studies page before you plan around a particular device, since the supported devices are configured per study.
A word on regulation. Capture is a data capture platform. It does not classify your device, submit to a regulator or make your study compliant with a device standard. Your regulatory route (for example, the US IDE process or a CE-marking route) and your quality management system are your own. What the platform provides is the evidence trail: a field-level audit trail, electronic signatures, role-based access and an exportable record, which you can show to your regulatory consultant and to the standard-focused page on ISO 14155 clinical investigation software.
Evening diary
Question 3 of 8
How would you rate your fatigue today?
0 = no fatigue, 10 = worst imaginable
Need to location
| Startup need | Why it matters | Where it lives in Capture |
|---|---|---|
| Move fast on the first study | Runway is short | AI study builder drafts visits and forms from the protocol; a person reviews |
| Control costs | Pay only for live studies | Free sandbox; paid plans start at go-live (pricing) |
| Consent participants properly | Ethics and site expectation | eConsent with email code and investigator countersignature |
| Collect outcomes remotely | Fewer site visits for follow-up | ePRO on the participant’s phone, no app |
| Show data integrity to investors | Due diligence | Audit trail, e-signatures, role-based access, exports |
| Run several sites | Pivotal-size evidence later | Site-level numbering, coordinator portal, by-site exports |
| Hand data to a statistician | Analysis and submissions | CSV/Excel with data dictionary, and SDTM export as SAS XPT with Define-XML |
Upload the draft plan, review the forms the AI proposes, and run practice cases in the free sandbox. No credit card.
Evidence quality
Investors, strategic partners and notified bodies read clinical data critically. A clean dataset has few missing values, queries closed with documented reasons, and a traceable chain from entry to analysis. Edit checks raise an auto-query when a value breaks a rule, so errors are fixed while the participant is still at the site. Calculated fields (for example BMI or the minutes between two date-times) remove arithmetic errors, and source data verification can be set per field so a monitor looks at what matters.
Think early about who will analyse the data. If your plan includes a biostatistician or contract analyst, agree variable naming and export formats before the first case. Our export to R, SAS and SPSS guide and sample size calculator are useful in that conversation.
The last startup-specific point is portability. If a larger partner later takes over the program, you will want to hand over complete data with its history. The data ownership and portability page explains what to expect and ask.
Before first participant
Visits, endpoints, safety definitions and follow-up written down.
Device identifiers, operator, procedure, deficiency and event linkage.
Your consultant confirms the route; Capture does not decide this.
The ethics committee approves the wording before eConsent is switched on.
Investigators, coordinators and admins each have their own login.
Practice case through consent, procedure, an adverse event, a query and an export.
Yes. It is self-serve: you build the study, test it free and go live without an enterprise sales call. Support is by email, typically answered within 24 hours, with documentation and video tutorials.
You build a deficiency form alongside the adverse event form and link the two. They are normally separate records.
No. It supports the data side of your own quality system with an audit trail, signatures and access control. Regulatory classification and compliance stay with you.
Yes. Capture is used from Phase 1 through Phase 3 style designs, with multi-site features for larger confirmatory studies.
The sandbox is free. Paid plans apply when you go live with real participants; see the pricing page.
Keep exploring
EDC for feasibility studies
Small, fast first studies.
EDC for medical device clinical trials
General device use case.
Clinical trial tools for startups
The wider startup toolset.
Clinical trial software without a CRO
Running a study in-house.
Capture platform
EDC, ePRO, eConsent and randomization together.
Pricing
How plans work.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.