Written and maintained by CASRAI Editorial Board
Last updated
Medrio is a San Francisco-based software vendor whose electronic data capture (EDC) system is used to collect and manage clinical trial data. This guide is for sponsors, clinical operations staff and data managers who need a neutral description of what the platform covers, what its published claims mean in regulatory terms, and which questions to settle before relying on any EDC system. Medrio’s own description of itself appears throughout; the vendor’s statements are attributed to it, not presented as independent findings. This page is general information, not procurement or regulatory advice.
What is the Medrio system?
Medrio markets itself as “the only EDC for small and scaling clinical teams.” Its core product is a clinical data management system (CDMS) built around electronic data capture: sites enter case report form data directly into a web system instead of onto paper. On its EDC page, Medrio describes the system as validated and audit-ready, with built-in edit checks, real-time validation, query workflows, role-based access controls, audit trails, and flexible data exports including single-click exports and casebook submission (vendor self-description, medrio.com, checked 2026-11-07).
Where is Medrio based?
Medrio’s website lists its headquarters at 345 California Street, Suite 600, San Francisco, California (medrio.com, checked 2026-11-07).
How much does Medrio cost?
Medrio does not publish prices. Its EDC page directs visitors to schedule a demo, so cost is quoted per engagement. No dollar figure is given here because none is published by the vendor. If you are comparing systems, ask each vendor to state in writing what is included in a quote: study build, number of users and sites, change orders after go-live, data export, and archiving at study close.
Modules and what each one does
Medrio lists several products on its homepage (checked 2026-11-07). The abbreviations are used loosely across the industry, so the table gives the plain meaning of each.
| Module (as listed by Medrio) | What this kind of system does |
|---|---|
| CDMS / EDC | Captures case report form data from sites, runs validation checks, manages queries, and stores the audit trail. |
| eCOA / ePRO | Collects clinical outcome assessments and patient-reported outcomes electronically from participants. |
| eConsent | Presents and records informed consent electronically. |
| RTSM | Randomization and trial supply management: allocates participants to arms and tracks study product supply. |
| CTMS | Clinical trial management system: tracks trial operations such as sites and monitoring, as distinct from the clinical data itself. |
| eTMF | Electronic trial master file: holds the essential documents of the trial. |
Medrio also lists clinical trial data services and project management as services alongside the software. Its EDC page says the system can integrate with its eConsent, RTSM/IRT, eCOA/ePRO and safety systems, and supports unplanned offline data capture and an always-on validation environment for testing changes.
Part 11 claims: what the vendor states and what you must verify
Medrio says its EDC aligns with FDA 21 CFR Part 11, with validated electronic records and signatures and full audit trails. “Aligns with” is a vendor statement, not a certification: FDA does not certify software as Part 11 compliant. Under 21 CFR Part 11, the sponsor remains responsible for using systems that meet the rule. The relevant controls in 21 CFR 11.10 include:
- Validation (11.10(a)): “validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.”
- Limited access (11.10(d)): “limiting system access to authorized individuals.”
- Audit trails (11.10(e)): use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records.
- Authority checks (11.10(g)): checks to ensure only authorized individuals can use the system, sign a record, or alter a record.
Source: 21 CFR 11.10 (Cornell Legal Information Institute text, checked 2026-11-07). A practical checklist for any EDC vendor, Medrio included, follows from these controls:
- Request the vendor’s validation documentation and ask how each software release is re-validated.
- Confirm you can view and export the audit trail, and that it records the old value, new value, user and time of each change.
- Check how user roles are set up for your study and who at the vendor can access your data.
- Confirm that your own study-specific build (forms, edit checks, calculations) is tested and the testing is documented before go-live. See edit checks in clinical data management.
- Ask what you receive at study close: data exports, audit trail and the form definitions needed to interpret them.
For a full regulatory checklist see the 21 CFR Part 11 compliance checklist. For the clinical data acquisition standard often used to design case report forms, see CDASH.
Strengths and limits
What the vendor emphasises: a focus on small and scaling teams, a suite that ranges from EDC to eConsent, RTSM, CTMS and eTMF under one vendor, and a testing environment kept separate from live data.
Limits: pricing is unpublished; the claims above are the vendor’s own statements and not independent findings; and the vendor’s EDC page does not name the data-exchange standards the system exports, so ask for a sample export during evaluation.
Where to find the sign-in
Registered users reach the sign-in link from the header of the Medrio website.
Alternatives
These descriptions come from each vendor’s own website (checked 2026-11-07) and are not rankings.
| System | How the vendor describes it | Pricing as published |
|---|---|---|
| Medrio | EDC for small and scaling clinical teams; also eCOA/ePRO, eConsent, RTSM, CTMS, eTMF | Not published; request a demo |
| OpenClinica | eClinical platform uniting EDC, eConsent, eCOA, randomization and EHR-to-EDC; “built for small to mid-size sponsors, CROs, and academic teams” | Main call to action is “Request a Quote” |
| Viedoc | eClinical trial data management solution with EDC, ePRO, televisits, eSignature, randomization, trial supply management and medical coding | “Modular, study-based”; says users are unlimited at no extra cost |
Academic teams that run their own database should also read about REDCap, a different model from vendor-hosted commercial EDC.
FAQ
What is the Medrio system?
A vendor-provided clinical trial software suite whose core is an EDC/CDMS for collecting and managing trial data, with optional eCOA/ePRO, eConsent, RTSM, CTMS and eTMF products.
How much does Medrio cost?
The vendor does not publish prices; costs are quoted on request after a demo.
Where is Medrio based?
San Francisco, California, per the address on its website.
Is Medrio Part 11 compliant?
Medrio states that its EDC aligns with 21 CFR Part 11. FDA does not certify software, so the sponsor should verify validation, audit trail and access controls itself using the checklist above.
Sources
- Medrio homepage: https://medrio.com/ (checked 2026-11-07).
- Medrio EDC page: https://medrio.com/solutions/edc/ (checked 2026-11-07).
- 21 CFR 11.10, Controls for closed systems: https://www.law.cornell.edu/cfr/text/21/11.10 (checked 2026-11-07).
- OpenClinica: https://www.openclinica.com/ (checked 2026-11-07).
- Viedoc: https://www.viedoc.com/ (checked 2026-11-07).
