The Triangle is unusual: a small sponsor can find a CRO, an academic medical centre and a recruitment site within a short drive. Capture gives that sponsor a data system it controls, so working with local partners does not mean accepting someone else’s EDC and timeline.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Sponsor study owner (admin)
Approves forms, sees coded data
Local CRO monitor and data manager (researcher)
Queries, SDV, listings
Academic medical centre site (site coordinator)
Enters data, sees names
Community research clinic (site coordinator)
Second recruitment site
Contract statistician (read-only exports)
SDTM and data dictionary
What is different about running early studies in the Triangle
The ecosystem
Research Triangle Park sits between Raleigh, Durham and Chapel Hill and is one of the largest research parks in the United States. Around it, university medical centres, a large pharmaceutical and contract research presence, and a steady stream of university spin-outs create an environment where a first-time sponsor can meet its investigators, its statistician and its CRO within a few miles. Industry reports rank the Raleigh-Durham market among the biggest life-science clusters in the country, helped by NIH funding and talent supply.
For an early-stage sponsor that concentration cuts two ways. It makes site selection and recruiting practical: a Phase 1b or Phase 2 study with an academic site and a community clinic is easy to assemble. But a CRO that offers everything often brings its own platform, and the sponsor can end up with a dataset and a build it cannot easily move. If you are weighing that, read clinical trial software without a CRO and how to choose a CRO before you sign.
The other recurring pattern is university spin-out science. A company growing out of a Triangle lab usually needs a regulated data system for its first investigator-sponsored or company-sponsored study without an in-house clinical operations group. Clinical trial software for university spin-outs and software for investigator-initiated trials describe that route.
Working with local partners
A typical Triangle study mixes a sponsor, a CRO, one or more academic or community sites and a statistician. Capture assigns researcher, site coordinator and admin roles, so each organisation sees what it needs and nothing more.
Study owner
Builds and configures the study
Principal investigator
Oversees the site, signs off the casebook
Sub-investigator
Enters and signs clinical data
Study coordinator
Screens subjects, enters visit data
Monitor (CRA)
Verifies data, raises queries
Data manager
Reviews, freezes and locks data
Participant
Completes their own questionnaires
Regulatory and ethics context
Academic medical centres in the Triangle typically run their own institutional review boards and clinical trial offices, and a sponsor working with several sites may use reliance arrangements or a commercial IRB so that review is not repeated at each institution. Which route applies is a conversation with each site’s research office and is not something software decides. The IRB glossary entry explains the role, and the blank eCRF PDF export gives the review board the forms in the format they expect.
On the data side, the sponsor’s responsibilities under 21 CFR Part 11 and ICH-GCP apply whichever site collects the data. Capture provides Part 11-aligned controls and an append-only, hash-chained audit trail; the audit trail software page shows what is recorded. For site operations, hospital research offices are a common stakeholder, and clinical trial software for hospital research offices covers how they evaluate a tool.
North Carolina participants are not all in one place, and many Triangle studies recruit regionally. Consent that is signed on a phone or tablet and countersigned by site staff can reduce travel and paperwork; see eConsent. Whether remote consent suits a given protocol is for the IRB to decide.
Build the study yourself, invite your CRO monitor and one site coordinator, and compare what they see. Free, every feature, no credit card.
Choosing
| Question | If the CRO supplies the EDC | If you run a self-serve EDC |
|---|---|---|
| Who owns the build? | Usually the CRO’s team; changes go through them | You, with the CRO as a user role |
| Time to change a form | Depends on the CRO’s change process | Edit a draft and approve; approved forms lock for live use |
| Switching CRO mid-study | Often means migration | Add or remove users; the study and audit trail stay |
| Dataset at close-out | Delivered by the CRO | Exported by you with data dictionary and SDTM |
| What you still need | Oversight of the CRO’s system | Your own validation position and SOPs |
Many sponsors use both: the CRO monitors in the sponsor’s EDC. Check the CRO contract before you decide. Capture is not a CTMS or eTMF.
Start-up
Name the person responsible for forms and edit checks, inside the sponsor or at the CRO under a role.
Upload the protocol and review the AI-proposed visits and forms. Add edit checks and calculated fields.
Invite the academic site coordinator into the sandbox and rehearse screening, dosing and an adverse event.
Export the blank eCRF PDF and build the eConsent version of the approved consent form.
Approve forms, invite all users and enroll. Paid plans apply from go-live; see pricing.
No. Capture is self-serve and remote, with email support and documentation. Book a demo online.
Yes. CRO monitors and data managers get researcher access with queries and source data verification, while the sponsor keeps admin control.
Site coordinators are invited by email and use the portal in a browser. Your site’s own policies on software still apply.
The audit trail is field-level, append-only and exportable, with timestamp, user, old value, new value and reason for change.
Capture provides 21 CFR Part 11-aligned controls. Compliance is shared with the sponsor’s validated use. This is not legal advice.
The sandbox is free and paid plans apply once you go live. See the pricing page.
Keep exploring
Clinical trial software for university spin-outs
Lab to first study.
Clinical trial software without a CRO
Running data yourself.
How to choose a CRO
Selecting a partner.
Software for investigator-initiated trials
Academic sponsors.
Clinical trial software for Bay Area biotech
The California hub.
EDC for Phase 1 trials
Early-phase safety data.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.