Clinicians across a hospital want to run studies, and the research office is asked to support all of them with a small team and no dedicated IT. Capture gives each study its own EDC, ePRO and eConsent build with role-based access and an audit trail, so your office sets the standard once and teams build within it.
Free sandbox · No credit card · 21 CFR Part 11 aligned
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What a hospital research office needs from software
The office’s problem
In many hospitals the research office is the place clinicians come when they want to start a study. Often they arrive with a spreadsheet, a general survey tool or a shared database that has worked for audits. These tools can feel adequate until a study needs an audit trail, a controlled change to a form, different access for a coordinator and a researcher, or evidence that a consent was signed before the first procedure. The office then inherits the risk of a study it did not choose the tools for.
The alternative many offices consider is a licensed enterprise EDC. That can be the right answer for a large portfolio, but it brings a contract cycle, setup work and per-study cost that does not match a department running its first small trial. The practical gap in between is a platform that a single investigator can start themselves, that still carries the controls an inspector expects. Our clinical trial software for study sites and investigator-initiated trial software pages discuss the same gap from the investigator’s side.
Capture is built to be that middle option. A study team can sign up, build its study in the free sandbox, test everything with practice data, and only pay when real participants are enrolled. The office does not need to run an implementation project for each department, and it can still look at the study design before it goes live.
Without locking teams in, the office can agree a short house standard: required roles, a common set of demographic, adverse event and concomitant medication forms (the template library has starting points), a naming convention for variables, and a rule that forms are approved before first enrolment. Forms move from draft to approved, and approved forms are locked for live use, which gives you a natural review point.
Need to location
| Office need | What it looks like | Where it lives in Capture |
|---|---|---|
| A consistent data standard | Same adverse event, demographics and medication forms across studies | Template library and approved-form lifecycle |
| Controlled access | Coordinators see names, analysts see coded data | Role-based access; site coordinators see participant names while researchers see coded IDs |
| Evidence of consent | Signed, dated consent before enrolment | eConsent with on-screen signature, email code and investigator countersignature |
| Participant questionnaires | Surveys and diaries completed outside clinic | ePRO tasks opened from a link on the phone |
| Audit readiness | Who changed what and why | Field-level audit trail on every record, exportable |
| Ethics submission support | Blank forms for the committee | Blank eCRF PDF export with cover page and visit-by-form matrix |
| Data location | Hospital data governance questions | Hosting in the EU (Frankfurt) or USA (N. Virginia) |
| Multi-site hospital studies | Several wards or partner hospitals | QR enrollment, site-level numbering, by-site exports |
Your data protection officer and ethics committee decide what is acceptable locally. Capture describes its hosting and controls; it does not replace your institution’s own review.
Pick one investigator-led study, build it in the free sandbox with practice data, and review it with your office. No credit card and no contract to start.
Governance
The usual tension in a hospital office is between autonomy and oversight. Departments want to build quickly, and the office needs to be able to say what each study collects, who has access and whether changes are controlled. Roles in Capture separate researchers, site coordinators and admins, and PII segregation means identifying details are visible to the staff who need them while analysis users work from coded IDs. Blinded roles do not receive treatment-arm values, and that is enforced at the database layer rather than only on screen.
The audit trail is the oversight tool the office can rely on. It records, per field, the user, timestamp, old value, new value and reason for change, and clinical data is soft-deleted only. When a department asks for help after a monitor’s question, the office can look at the record history rather than reconstructing it from emails. For the control set in more detail, see role-based access control for clinical trials and the 21 CFR Part 11-aligned EDC page. Part 11 responsibility is shared between the software and the institution’s own validated use of it, so the office’s procedures still matter.
Validation is the other question offices ask. Our computer system validation page explains how a team can approach it, and the free sandbox can double as the environment where a department runs its own user acceptance testing before go-live, as described on the UAT sandbox page.
Onboarding
The investigator shares the protocol. The office decides whether the study needs EDC, ePRO, eConsent or all three.
Upload the protocol and let the AI study builder propose visits and forms. Nothing is saved without human review.
Check roles, required forms, edit checks and the blank eCRF PDF before the ethics submission. The IRB submission checklist helps.
Enter practice participants, raise a query, sign a test consent, and check the export.
Approve the forms and start enrolling. The paid live phase starts when real participants enrol; see pricing.
For the office
Agree the data-ownership and portability position; see clinical trial data ownership and portability.
Choose EU or US hosting to match your data governance policy.
Map investigators, coordinators and data managers to Capture roles.
Pick the shared forms every study should start from.
Email support, documentation and video tutorials are available; your office decides its first-line role.
Decide what documentation the institution expects before a study goes live.
No installation is needed. Capture is browser-based and a study team can start in the sandbox on its own. Your IT or data protection teams may still want to review hosting and access policies.
Yes. Each study is built separately with its own forms, roles and audit trail, and the office can apply a house standard through shared templates and review before go-live.
Capture provides 21 CFR Part 11-aligned controls: field-level audit trail, electronic signatures and role-based access. Compliance is shared with your institution’s own validated use. This is not legal advice.
In the EU (Frankfurt) or in the USA (N. Virginia).
The sandbox is free with every feature, with no credit card and no time limit. You pay only once you go live with real participants. See pricing.
Keep exploring
Clinical trial software for universities
The academic counterpart to this page.
EDC for investigator-initiated trials
The clinician-led trial view.
Clinical trial software for research institutes
For institute-level programs.
Role-based access control
Roles and PII separation.
IRB submission checklist
What to prepare for ethics review.
eConsent
Electronic consent for participants.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.