When you are the whole CRO, the EDC has to be something you can build, test and hand over yourself. Capture lets one person draft a client’s study from the protocol, rehearse it in a free sandbox with the sponsor, and run it with roles for sites and monitors, on one audit trail.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Live client studies
3
Open queries
17
Forms awaiting approval
2
Sites enrolling
5
queries open
queries open
queries open
What a one-person CRO needs from an EDC
The consultant position
An independent consultant is typically hired for one of three things: to run clinical data management for a small sponsor, to act as the sponsor’s representative alongside sites and a CRO, or to set up and oversee a study end to end. In all three the client is paying for your experience, and any tool cost lands on a small project budget or on your own margin. An enterprise EDC with an annual platform fee, a statement of work for the build and a contract longer than the study does not fit that model.
The practical requirement is therefore to run the work alone. You write the specification, build the forms, add edit checks and visit windows, test with the sponsor and train the sites. That is a lot for one person, and it is the main argument for an AI-assisted first draft that you review rather than a blank screen: upload the protocol, check the proposed visits and forms, and spend your time on the parts that need clinical and data-management judgement. For how a small team does this without a CRO, read clinical trial software without a CRO and how to run a clinical trial without a CRO. If the client is considering hiring a full CRO instead, how to choose a CRO frames that decision fairly.
Be explicit about the arrangement with each client. Who is the sponsor, who is the data controller, who signs off the specification, and who owns the final dataset? A consultant is not the sponsor unless the contract says so, and the tool should make that separation easy to show: the client’s staff get their own roles, and the dataset leaves in a standard format. The data ownership and portability page lists the questions to put to any vendor.
Study build
Upload the protocol as PDF, DOCX or DOC and the AI study builder drafts the visit schedule and forms. You review each one, add edit checks and calculated fields, and approve forms before they can be used live. The same person can then invite the client into the sandbox.
Stage 1
DraftBuild and edit freely
Stage 2
ApprovedLocked for live use
Stage 3
In the casebookOnly approved forms
SDV requirement changed on Systolic BP
Data manager · Reason: critical safety value
Form approved: Vital Signs (VS) v2
Study owner · Locked for live use
Answer changed: Weight 68.0 to 68.5 kg
Site coordinator · Reason: transcription error
Task to tool
| Consultant task | What it involves | Where it lives in Capture |
|---|---|---|
| Specification and build | Turn the protocol into forms | AI draft from protocol, visual builder, template library |
| Data cleaning rules | Limit bad data at entry | Edit checks, calculated fields, visit windows |
| Sponsor UAT | Let the client try it first | Free sandbox with every feature |
| Site training and access | Get coordinators working | Site coordinator portal, QR enrollment, site-level numbering |
| Query management and SDV | Keep the data clean | Auto-queries, manual queries, SDV configurable per field |
| Randomization | Allocate without a second system | In-platform randomization with blinded roles |
| Close-out deliverables | Hand the dataset over | CSV/Excel with data dictionary; SDTM as SAS XPT with Define-XML |
| Audit questions | Show what happened | 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 client contract govern how they are used.
Take a protocol you are quoting, upload it, and show the client a working study before they sign. Free sandbox, every feature, no credit card.
Boundaries
Capture does not replace your trial master file, a CTMS or the sponsor’s regulatory submissions; see EDC vs CTMS and EDC vs eTMF. It also does not replace your own quality system. A one-person firm still needs SOPs for specification, testing, user access and close-out, and a clear statement of what validated use means for each client. The computer system validation guide describes a proportionate approach.
Working alone also means single points of failure. Agree a continuity plan in the contract: a named backup, who holds admin access if you are unavailable, and how the client can reach their data. Role-based access helps you keep your own admin rights separate from the client’s study owner role, and exports are always available to the people who should have them. For monitoring-heavy studies, a monitoring visit report in your own format works alongside the platform; see the monitoring visit report template and risk-based monitoring and SDV.
If you grow beyond one person, the same studies carry over to a small team without migration, and clinical trial software for regional CROs describes that stage.
Workflow
Agree modules (EDC, ePRO, eConsent, randomization), role owners and what you are and are not responsible for.
Upload the protocol, review the AI draft and build the forms from templates where you can.
Invite the sponsor into the sandbox, rehearse entries and queries, and keep sign-off in your own records.
Invite site coordinators and run a short session on entry, queries and consent.
Approve forms, enroll, clean data and deliver exports with the data dictionary at close-out. Paid plans apply from go-live; see pricing.
Before the first engagement
Your validation and user-access SOPs mention the platform and your sponsor-facing responsibilities.
Who is controller, who is processor, which hosting region (EU Frankfurt or USA N. Virginia).
A real export and data dictionary opened by the client’s statistician.
Email support, typically under 24 hours, plus documentation and video tutorials.
A second admin or a documented handover plan for each live study.
For many small studies, yes. The AI study builder drafts visits and forms from the protocol, and you review and refine them in a visual editor. Complex studies still need clinical and data-management judgement, which is the part you bring.
Yes. Each study is built separately with its own forms, roles and audit trail.
Yes. Exports include a data dictionary, and SDTM datasets are available as SAS XPT files with Define-XML. Agree data ownership in your contract.
No. It is an EDC, ePRO, eConsent and randomization platform with safety reporting and monitoring workflows. Keep your trial master file and operations tracking in your own tools.
Capture provides 21 CFR Part 11-aligned controls. Compliance is a shared responsibility with the sponsor’s own validated use. 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 to discuss your volume.
Keep exploring
Clinical trial software for regional CROs
When the practice grows into a team.
Clinical trial software without a CRO
Sponsors who run studies themselves.
Best EDC for CRO small studies
Small client studies.
EDC for CRO independent trials
Independent and sponsor-led trials.
Software for clinical data managers
Data manager workflow.
EDC UAT in the sandbox
Rehearse with the sponsor.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.