A spin-out inherits academic habits: a founder who ran studies on a university tool, a small team and a first investor. The next study is a company study, with new obligations. Capture bridges that move with Part 11-aligned controls, a free sandbox and no enterprise contract.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study overview and data flow
Forms, variables and edit checks
Roles, access and audit trail
Confirm who holds which role
Query management and SDV
Exports and database lock
Hand-over to partner or CRO
What changes when a project leaves the university
The transition
Inside a university, a study runs under the institution’s umbrella: its ethics office, its data governance, its shared infrastructure and often its own licensed research database. When a technology is licensed to a spin-out and the company takes the next study forward, that umbrella is gone or reduced. The company becomes the sponsor and has to show that its data system supports the study without relying on the university’s tooling.
Many academic groups use REDCap, and it is a good tool for many academic purposes. Our REDCap alternatives and REDCap for commercial industry trials pages discuss when teams look beyond it, and How to migrate from REDCap shows the practical path. Capture is also a more regulated alternative to REDCap for teams that need Part 11 controls, with a field-level audit trail, electronic signatures, role-based access and query management in the same system.
Whether the university’s licence or hosting agreement extends to a company is a legal question for your technology transfer office and counsel, and we do not advise on it here. The practical point is to plan the data system separately from the licence: pick a tool the company can own an account for, with exports it can take with it.
Keep the forms, the variable naming and the protocol wording that already survived peer review. The form templates and the AI study builder can start from them. A founder who already wrote the protocol can upload it and review the drafted visits and forms; nothing is saved until a person approves it.
Sponsor duties
A sponsor is responsible for the quality of the data and for oversight of everyone who handles it. Capture does not do that for you, but it supplies the parts a small team cannot easily build: an audit trail that cannot be changed through the interface, e-signatures with re-authentication, roles that separate who can see identifying details, and a query workflow where open items are visible. Monitoring workflows, including source data verification set per field and a monitoring dashboard, help the one person who is both the clinical lead and the data manager.
Safety reporting needs structure early. Use the adverse event form and SAE report form as starting points and agree causality and seriousness definitions with your medical monitor. The adverse event reporting software page describes the workflow. Regulatory and ethics requirements depend on the country and the product; the FDA IND guide for academics and the UK MHRA regulations guide are general orientations, not advice.
The company also needs its own paperwork. A data management plan template and a clinical trial protocol template are available as editable documents. If an investor or partner sends a security or vendor questionnaire, our vendor security questionnaire page and the security page describe what we can and cannot attest to today.
Need to location
| Spin-out need | Academic starting point | Where it lives in Capture |
|---|---|---|
| Controlled, auditable data | Shared database or spreadsheet | Field-level audit trail, e-signatures, role-based access |
| Reuse existing forms | Existing instrument and data dictionary | Form builder, templates and AI drafting from a file (CSV, XLSX, PDF, DOCX), reviewed by a person |
| Participant consent | University consent template | eConsent with countersignature and signed PDF export |
| Patient-reported outcomes | Survey tool | ePRO on the participant’s phone with reminders |
| Randomization | Spreadsheet or statistician-supplied list | Randomization in the same platform, with blinded roles |
| Partner or CRO hand-over | Ad hoc data transfer | CSV/Excel with data dictionary, SDTM export (SAS XPT with Define-XML) |
| Grant or investor reporting | Manual summary tables | Dashboards and exports from the study |
Institutional licences, intellectual property and data-transfer agreements are legal matters for your technology transfer office.
Bring your protocol or data dictionary into the free sandbox and see the forms, consent and audit trail as an investor or partner would. No credit card.
First 90 days
List forms, instruments and data from the academic study that the company can reuse, and the licences or permissions each requires.
Draft visits and forms from the protocol, add edit checks and calculated fields, and approve the forms.
Data management plan, monitoring plan and safety plan, using templates as a starting point.
Run in-house, or work with a regional partner. See clinical trial software without a CRO and how to choose a CRO.
Approve forms, invite sites and start enrolling. Paid plans begin at go-live; see pricing.
Before first participant
The company, not the university, is named as sponsor where that is the case.
Questionnaire terms checked with their rights holders and filed with study documents.
Who holds the original academic data and what may be reused.
The clinical lead, data manager and monitor each have a role with the right access.
How data will be exported and handed to a partner.
Practice participants through consent, a visit, an event and an export.
Yes. Many teams rebuild forms in Capture and export historical data from REDCap for reference. See the migration guide linked on this page. Whether the old data may be reused is a question for your agreements.
Yes. It provides Part 11-aligned controls and runs studies from Phase 1 through Phase 3 style designs. Compliance is shared with the sponsor’s own validated use.
You can upload a CSV, XLSX, PDF or DOCX and the AI drafts questions or tables for review. Nothing is saved until a person approves it, and it only works on draft forms.
Not necessarily. Capture is self-serve, and many small teams run without one. Whether you need one depends on your capacity and the study.
The sandbox is free with every feature, and you pay once you go live with real participants. See the pricing page.
Keep exploring
REDCap alternatives
When teams look beyond REDCap.
How to migrate from REDCap
A practical migration path.
Clinical trial software for startup biotech
The seed-stage view.
Data management plan template
An editable starting point.
Clinical trial software for universities
Before the spin-out.
Capture EDC
The EDC product page.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.