San Diego biotech runs on lean teams, shared lab space and CRO-heavy development. Capture is the study system a clinical lead can set up alone: forms, diaries, consent and queries in one place, hosted in the USA (N. Virginia), with no enterprise EDC contract and a free sandbox first.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Protocol draft from CRO partner
Uploaded as PDF or DOCX
Forms and visits drafted by AI, reviewed by clinical lead
Nothing saved until approved
Sandbox rehearsal with two sites
Edit checks, queries, e-signatures
IRB package: blank eCRF PDF, eConsent text
Go live and enrol first participant
What the San Diego context changes
The landscape
San Diego is known for life sciences clustered around research institutes, a major public university and a long tail of venture-backed companies. A common model is the virtual biotech: a small core team, a CRO running the trial, and a handful of specialist vendors. The risk in that model is the hand-off. Data lives in the CRO's EDC, the sponsor sees it in a monthly extract, and questions about a query take days to resolve. A system the sponsor controls directly shortens that loop, even when a CRO runs monitoring.
For a company that wants to hold its own study build, the practical steps are small. Draft the forms from the protocol, add edit checks that raise queries at entry, give the CRO and sites role-based access and keep the sponsor in the audit trail. If you work with a CRO that has its own EDC, compare the approaches in best EDC for CRO small studies and clinical trial software without a CRO. For the founder view, see clinical trial software for biotech founders.
The speed argument is real. Capture lets you build in a free sandbox without a contract, so the decision is made on a working study rather than a slide deck. Compare that to the cost and timeline picture in edc implementation timeline.
Beyond the site visit
Phase 2 programmes in dermatology, metabolic, CNS and pain often depend on what the participant reports between visits. Capture's ePRO opens from a phone link with reminders, and eConsent uses an on-screen signature with email OTP confirmation. Both sit in the same study and audit trail as the site forms.
Regulatory context
A US-sponsored drug or biologic study typically runs under an IND with FDA and ethics review by an institutional or commercial IRB, and the data system sits under the sponsor's 21 CFR Part 11 responsibilities. Capture provides Part 11-aligned controls, but validated use is shared with the sponsor. Device companies should see EDC for medical device clinical trials.
California adds state-level privacy and health-information rules on top of HIPAA at clinical sites. How those apply to research data is a question for your counsel and privacy officer. Capture describes its infrastructure as HIPAA-ready and GDPR-ready, with AES-256 encryption at rest and TLS in transit; read HIPAA vs GDPR for clinical trial data before you decide where data should live.
For academic collaborators at local institutions, the FDA IND application guide for academics is a useful companion. This is not legal advice.
Upload your draft protocol, review the AI-drafted forms and invite a CRO colleague into the sandbox. Free, every feature, no credit card.
Choosing a model
| Option | Typical fit | Trade-off |
|---|---|---|
| CRO's own EDC | Large multi-country trial fully outsourced | Sponsor sees data through extracts; changes go through CRO change orders |
| Enterprise EDC contract | Large pivotal programme with a data management team | Long build and contract cycle |
| Self-serve platform (Capture) | Phase 1-3 with a small team that wants control | Sponsor owns the build; CRO and sites are users with roles |
Phase 1, 2 and 3 are all suitable on Capture. Pick on team shape and timeline, not phase.
Start-up
USA (N. Virginia) for a US-only study; EU (Frankfurt) if European sites join.
Upload the protocol and review the AI-drafted visit schedule and forms.
Run test participants end to end; trigger a query on purpose.
Export the blank eCRF PDF and build the eConsent version of the consent form.
Invite site coordinators. Paid plans apply from go-live; see pricing.
No. Capture is self-serve and remote, with email support, documentation and video tutorials. You can book a demo online.
Yes. A CRO can be given role-based access to your study. Role design is yours to set up with the CRO.
In the USA (N. Virginia) or the EU (Frankfurt), chosen at study setup, encrypted at rest and in transit.
Yes for the clinical study data: site forms, patient-reported data and consent. Regulatory strategy stays with you. See the medical device EDC page.
Capture provides 21 CFR Part 11-aligned controls. Validated use is shared with the sponsor. This is not legal advice.
The sandbox is free and paid plans apply when you go live. See the pricing page.
Keep exploring
Clinical trial software for biotech founders
The founder view.
Clinical trial software for San Francisco Bay Area biotech
The northern California hub.
Best EDC for CRO small studies
Working with a CRO.
EDC for Phase 2 clinical trials
Phase 2 build.
HIPAA vs GDPR for clinical trial data
Where data should live.
EDC for medical device clinical trials
Device studies.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.