Source data verification (SDV) confirms that the data in your electronic data capture system matches the original patient records at the site. Remote SDV lets your team do that review online, without going on site.
SDV is one piece of a monitoring plan, and most sponsors have already narrowed it through risk-based monitoring, verifying fewer fields on fewer patients. What that did not change is how the remaining verification gets done. Teams still plan around a full schedule of on-site visits, struggle for direct access to dozens of electronic medical records, or chase source documents through email and shared drives.
On site or through direct record access, monitors can perform SDV but cannot preserve the records they reviewed. The visit is documented; the review is not.
Judi is a secure platform for collecting patient records electronically, validated to support your 21 CFR Part 11, HIPAA and GDPR obligations. Every document reviewed stays with the review, so you get fewer site visits, faster data cleaning, lower monitoring costs and proof of exactly what was verified.
Most SDV still runs on-site. Travel costs add up. Resource burden is high. Manual attempts to perform SDV off-site are problematic. Source documents move through email and shared drives. Status lives in spreadsheet trackers. It’s expensive, invites friction and is hard to defend at audit.
Verify source data online and cut the travel, time and budget that on-site visits consume. AI-assisted redaction, built-in query management and side-by-side EDC comparison reduce labor, increase accuracy and speed data cleaning. Centralizing the work means a smaller team can cover more sites at lower cost.
Collect the exact patient records each protocol requires, without waiting on a monitor to travel. Compare critical EDC fields against the patient records that document them. Sites and your SDV team work in one shared workspace, so comparison and queries happen in the same pass rather than as separate steps weeks apart. Data cleaning runs on a rolling basis instead of in bursts around visits.
Every document reviewed is collected, preserved and stored with the review that used it, so you can show exactly what was verified, by whom and when. Uploads, redactions, comparisons, queries: each action is captured as it happens, with the before and after of anything that changed. When an inspector asks what was verified, the answer is the file itself, not a reconstruction.
Configure source collection to match your monitoring plan.
Collect patient records straight from sites, on a platform built for global privacy law.
Compare critical EDC fields against source documents in one view.
AI finds all protocol-defined PHI, with human review of every redaction.
Non-English source documents can be translated inline through our TransPerfect integration.
Raise and resolve queries on patient records in the same pass.
Retain the exact records used for SDV as proof the work followed your monitoring plan.
Every action is captured and timestamped in real time, keeping the record complete and always inspection-ready.
Monitor trial-wide SDV status, cycle times and site performance in real time.
Native tools built in Judi include AI-assisted PHI redaction. In remote SDV, redaction is a gate: every hour spent masking records by hand is an hour verification waits. Judi scans patient records for required identifiers and a human reviewer approves each one, so documents move straight into verification.
AI needs somewhere to work. Judi is that place, for its own AI tools and for any proprietary or third-party models you bring. The guardrails come with it. Each model is governed exactly like a human team member: assigned to specific duties with defined steps, managed under the same permissions and tracked in the same audit trail, with human-in-the-loop oversight throughout. The technology handles the heavy lifting; humans own the decision.
Source data verification, or SDV, is the process of checking that the data recorded in a trial’s electronic database matches the original source records at the site. Remote SDV performs that same check online, so verification no longer depends on someone traveling to each site.
They answer different questions. Remote SDV checks whether specific data points in the trial database match the source records. Remote source document review looks at the source documents themselves for quality, completeness and protocol compliance, without a field-by-field comparison against the database. Most monitoring plans use both, with SDV targeted at critical data and document review applied more broadly.
Remote SDV cannot replace 100 percent of your on-site monitoring visits. What it does is re-allocate the time spent performing the data verification portion of traditional on-site visits to remote visits. That means you can plan on a significantly smaller pool of costly on-site visits, and you can shift the focus of the visits that remain to the activities that must be done on site.
Judi is a clinical trial optimization platform that supports the full remote SDV workflow in one place. Source collection is built to your monitoring plan. Sites submit the specific patient records documenting the critical fields that require SDV directly into the platform. PHI is redacted online with AI assistance and human approval. Your SDV team compares source against EDC data side by side, and discrepancies result in queries for data cleaning. Every action is captured as the work happens, in a complete audit trail.
Any of them. Judi connects to your EDC through an open API, so source data flows straight into remote SDV with nothing re-keyed. Integrations are live now, with more underway. Contact us for the current list.
Savings come from three places: less travel, less manual effort, and the ability to centralize the work so appropriately qualified clinical staff can perform it rather than sending CRAs on site. In a remote monitoring case study, Judi cut cost per visit by 86 percent and labor per visit by 60 percent, for a 43 percent reduction in overall monitoring cost. Travel cost per visit fell to zero for remote visits. Remote SDV does not eliminate travel entirely, since some on-site visits remain necessary, but it removes SDV as the reason to make them.
No. Remote SDV depends on judgment about whether a source record supports the data recorded in the trial database, and that determination belongs to qualified clinical staff. AI does the work around that judgment rather than the judgment itself. In Judi, every AI output lands where a person reviews it and makes the call, and the record shows what AI proposed, who reviewed it and what they decided.
Judi can support any and all clinical trial workflows, each configured to the protocol and project plans it serves, on one validated platform. Most trials run eligibility, imaging, DSMB, remote source data verification and adjudication. Also running today: user qualification, IRB, screening coordination, document development, 24/7 medical monitoring, clinical safety, protocol deviations and steering committee. We continually roll out new workflows. Need a workflow that isn’t here? If you can draw it, we can build it.
Yes. Judi is SOC 2 Type 2 certified and holds active certification under the EU-U.S. Data Privacy Framework, including the UK Extension and the Swiss-U.S. DPF. The SOC 2 examination is an independent CPA review of the design and operating effectiveness of our security controls, performed every year since 2021, with no exceptions noted in the most recent report. Judi operates as a data processor and business associate on behalf of sponsors and CROs, and is designed and validated to support your 21 CFR Part 11, HIPAA and GDPR obligations, covering electronic records and signatures, audit trails and access controls. Source documents are collected, redacted and reviewed in a validated, access-controlled platform, with every action captured in a timestamped audit trail. AG Mednet supports client security questionnaires, vendor assessments and audits as part of standard engagement, and can share evidence on request.