A regional CRO wins work on responsiveness, local knowledge and price. Your EDC should not undermine any of those. Capture lets a small team build a client’s study in the sandbox, run it with roles for sites and monitors, and deliver exports, with one audit trail across EDC, ePRO and eConsent.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Forms approved
9 of 11
Sites ready
2 of 4
What a regional CRO needs from its EDC
The CRO position
Regional and boutique CROs typically win on proximity to sites, familiarity with local regulators and ethics committees, and the ability to give a small sponsor real attention. The cost to protect is the platform: a large EDC licence, a validation burden per sponsor, and weeks of build before the first screening visit can all erode the margin on a modest study.
A self-serve platform changes the arithmetic. A data manager can upload the client’s protocol, review the AI-drafted visits and forms, then adjust edit checks and visit windows in a visual builder. The same person can rehearse the study in the sandbox with the client, so user acceptance testing happens on the real build. See EDC build speed and UAT for how to use a sandbox that way. The fixed cost of starting a client study falls, and you can bid on studies that previously did not justify an enterprise setup.
We cover related pages from the CRO side too: CRO EDC, best EDC for CRO small studies and EDC for CRO independent trials. If you serve site networks, see SMO and site network software.
Operations
A CRO usually has at least four kinds of people in a study: its own data managers and monitors, the client’s staff, site investigators and site coordinators. Capture’s roles separate researcher, site coordinator and admin access, with PII segregation so coordinators see participant names while researchers work from coded IDs. Blinded roles do not receive treatment-arm values. For the model in depth, see role-based access control and blinded and unblinded role management.
Multi-site operation is built in: QR-code enrollment (site-specific or study-specific, with no app install), site-level participant numbering such as 001-0042, a separate site coordinator portal and by-site filtering and exports. Monitoring work uses query management, source data verification configurable per field, and a monitoring dashboard; the risk-based monitoring and SDV page and protocol deviation tracking describe the workflow. The monitoring visit report template gives a document structure for visits.
Be realistic about scope. Capture is an EDC, ePRO, eConsent and randomization platform with safety reporting and monitoring workflows. It is not a CTMS or an eTMF; see EDC vs CTMS and EDC vs eTMF. Most CROs already have their own tools for trial master file and operations tracking, and Capture sits beside them.
Need to location
| CRO need | What it looks like | Where it lives in Capture |
|---|---|---|
| Fast study build | Protocol to working forms in days, not weeks | AI study builder from PDF, DOCX or DOC; visual form editor; human review before saving |
| Data cleaning | Fewer manual queries | Edit checks raise auto-queries; manual queries in the action list |
| Monitoring | Targeted verification | SDV configurable per field; monitoring dashboard |
| Site operation | Several sites with local staff | Site coordinator portal, site-level numbering, QR enrollment |
| Randomization and blinding | Allocation without a separate system | Randomization in-platform; blinded roles enforced at database layer |
| Participant tools | Consent and diaries | eConsent and ePRO in the same study |
| Client deliverables | Datasets for statistics | CSV/Excel with automatic data dictionary; SDTM as SAS XPT with Define-XML |
| Audit readiness | Client and inspector questions | Field-level audit trail, e-signatures, exportable history |
Sponsors remain responsible for validated use under Part 11. Capture provides 21 CFR Part 11-aligned controls; your SOPs and the sponsor agreement govern how you use them.
Take one real protocol, upload it, review the AI draft and show the client a working study. Free, with every feature and no credit card.
Workflow
Agree which modules are in scope (EDC, ePRO, eConsent, randomization) and who owns each role.
Upload the protocol, let the AI propose visits and forms, and review every field with the data manager.
Edit checks, calculated fields, visit windows and SDV settings.
Invite the sponsor to the sandbox, rehearse entries and queries, and record sign-off in your own documents.
Approve forms, invite sites and start enrolling. Paid plans start at go-live; see pricing.
Commercial fit
CROs price studies by scope, and platform cost is one input. A free build and test phase means you can show the client a working study before the contract is final, and payment starts only when the study is live. For the cost principles, see EDC per-patient pricing explained and hidden EDC fees; the exact plan that fits your volume is something to confirm with us on the pricing page or in a demo.
Also decide what you tell clients about data ownership. Exports are available with a data dictionary, and the data ownership and portability page lists the questions a sponsor should ask any vendor, including us.
Before the first CRO study
Your own validation and SOP position for using a new EDC.
Who is data controller, who is processor, where data is hosted (EU Frankfurt or USA N. Virginia).
Monitors, data managers, site staff and sponsor users each have a role.
A house set of adverse event, demographics and medication forms from the template library.
A sample export and data dictionary opened by your biostatistician.
Email support and documentation, with enterprise options for training and validation documentation.
No. It is an EDC, ePRO, eConsent and randomization platform with safety reporting and monitoring workflows. Most CROs run their trial master file and operations tracking in separate tools.
Yes. Each study is built separately with its own forms, roles and audit trail.
Speed depends on your protocol. The AI study builder drafts visits and forms from an uploaded protocol, and a person reviews before anything is saved, which shortens the first build.
Yes. The free sandbox has every feature, so a sponsor can rehearse entries, queries and signatures before go-live.
Capture provides 21 CFR Part 11-aligned controls. Compliance is shared with the sponsor’s own validated use, and your SOPs apply. This is not legal advice.
The sandbox is free, and paid plans apply when a study goes live. See the pricing page or book a demo.
Keep exploring
CRO EDC
EDC for contract research organisations.
Best EDC for CRO small studies
Small and mid-sized client studies.
EDC for CRO independent trials
Independent and sponsor-led trials.
Risk-based monitoring and SDV
Monitoring workflow.
Multi-site clinical trial management
Sites, numbering and exports.
Capture platform
The whole platform.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.