A university spin-out in the Golden Triangle can have a strong asset, a founder who is also the chief scientist, and a Phase 1 unit waiting for a protocol. Capture gives that team a self-serve EDC, ePRO and eConsent it builds itself, with EU (Frankfurt) hosting and no enterprise EDC contract.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study
DEMO-FIH-01
Cohorts
4 planned
Hosting
EU (Frankfurt)
What the Oxford and Cambridge context changes
The cluster
The Oxford and Cambridge corridor, often called the Golden Triangle with London, is where a lot of UK university science becomes a company. A typical spin-out has a lead programme from an academic lab, a seed or Series A round, rented lab space and an advisory board of clinicians. The clinical function is usually a chief medical officer, perhaps a clinical operations lead and an outsourced CRO or Phase 1 unit. Nobody has the title "data manager", and nobody wants to negotiate a multi-year enterprise EDC contract before the first dose.
That shape suggests a short list of requirements. The system has to be buildable by the people in the room, it has to change when the protocol changes after the scientific advisory board meeting, and it has to be something a Phase 1 unit, an investor diligence team and a regulator can trust. Capture is built for exactly that kind of team: upload the draft protocol, review the AI-drafted visits and forms, add edit checks, approve and lock forms, and rehearse with the site in the free sandbox. The pattern is the same one described in clinical trial software for university spin-outs and clinical trial software for early-phase trials.
If you are a US reader looking for the other Cambridge, see Boston and Cambridge, Massachusetts. This page is about the UK cluster.
The first study
A first-in-human study produces dense safety data at tight time points: vital signs, ECGs, laboratory values, adverse events and concomitant medicines. Capture lets a small team build those forms from templates, link them to the visit schedule and see queries as they arise.
Edit checks / auto-queries
2Type
Range High
Operator
Greater than
Value
180
Priority: High
Type
Range Low
Operator
Less than
Value
80
Priority: Normal
Query raised automatically
Value 192 violates limit (180). Please verify.
Regulatory context
Clinical trials of medicines in the UK are regulated by the MHRA, with ethics review through the Health Research Authority system. The Medicines for Human Use (Clinical Trials) Regulations were amended, and sources report the new rules took effect on 28 April 2026, with changes to approvals, transparency, consent and safety reporting and a reference to ICH E6(R3). Transitional arrangements may apply to applications already in the system. Read the MHRA guidance and our UK MHRA clinical trial regulations guide and confirm the current position with your regulatory adviser.
The data system sits underneath. Capture provides 21 CFR Part 11-aligned controls (field-level audit trail, e-signatures, role-based access) that map well onto the expectations for a validated, auditable electronic system, but validated use is shared with the sponsor and your quality documents carry that. For the technical background see GDPR-compliant clinical trial software and ICH E6(R3) guide for clinical trial teams. This is not legal advice.
Because data is hosted in the EU (Frankfurt) rather than in the UK, a UK sponsor should ask its data protection adviser how that fits its transfer arrangements. Capture does not offer UK in-country hosting, and the page does not claim it.
Upload the draft protocol, review the AI-drafted forms and invite the unit into the sandbox this week. Free, every feature, no credit card.
Need to location
| Need | Why it matters here | Where it lives in Capture |
|---|---|---|
| Fast first-in-human start | Seed runway is tied to a first clinical dataset | AI draft from protocol, visual builder, free sandbox |
| Safety review between cohorts | Escalation decisions depend on clean data | Vitals, ECG, lab and AE forms with edit checks and auto-queries |
| Dose blinding | Placebo or blinded cohorts | In-platform randomization; blinded roles enforced in the database |
| Participant consent | Healthy volunteers and patients | eConsent with email OTP and countersignature |
| Investor and partner diligence | Data-integrity questions from a pharma partner | Append-only, hash-chained audit trail; exportable history |
| Academic collaborators | Co-investigators at the university | Role-based access, by-site data filtering |
Capture is not a CTMS, an eTMF or a regulator-approved service. You keep your clinical trial application, ethics and quality documents.
Start-up
EU (Frankfurt) is the closest region to UK sites; confirm the transfer position with your data protection adviser.
Upload the protocol, review the AI draft, add edit checks and approve the forms. Approved forms lock for live use.
Run test volunteers through screening, dosing and follow-up and raise a query on purpose.
Export the blank eCRF PDF for ethics review and build the eConsent version of the participant information.
Invite site staff and start enrolling. Paid plans apply from go-live; see pricing.
No. Capture is self-serve and remote, with email support, documentation and video tutorials. Data is hosted in the EU (Frankfurt) or the USA (N. Virginia). It does not offer UK in-country hosting.
Yes. Teams build forms from templates and an AI draft, test them in the sandbox and go live when ready. MHRA, ethics and monitoring remain with you or your CRO.
Capture provides 21 CFR Part 11-aligned controls such as a field-level audit trail, e-signatures and role-based access. Validated use is shared with the sponsor. This is not legal advice.
The regulations govern the trial, not the software. Sources report they took effect in April 2026. Check MHRA guidance and your regulatory adviser for what applies to your application.
Yes. CSV or Excel with a data dictionary, and SDTM datasets as SAS XPT with Define-XML.
The sandbox is free and paid plans apply when you go live. See the pricing page.
Keep exploring
Clinical trial software for university spin-outs
The spin-out view.
EDC for first-in-human studies
Dose escalation data.
UK MHRA clinical trial regulations guide
The UK rules explained.
Clinical trial software UK
UK overview.
Boston and Cambridge (US) biotech
The other Cambridge.
GDPR-compliant clinical trial software
Where data should live.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.