One surface, one record. It starts with eSource and a site CTMS where every visit is captured once and locked by the investigator, and DIRECT, which delivers that record into the sponsor's EDC. Every other application runs on the same record.
Entered once, by the person who saw the patient. Server-timestamped at the moment it is born. Locked by the investigator as a numbered, fingerprinted version. The sponsor reads the same record the site wrote.
| Step | The legacy stack | smartSOURCE |
|---|---|---|
| Capture | Chart, paper source, then EDC: keyed three times | Entered once, at the visit, attributed at entry |
| Verification | A monitor flies in months later to compare copies | The monitor reads the live record, read-only |
| Sign-off | Wet ink on paper, scanned later | Investigator signs with their password; the version is frozen |
| To the sponsor | Transcribed into the EDC by hand | DIRECT delivers the locked visit as an attributed entry |
| Database lock | Pending, months after last patient out | Nothing to reconcile, so nothing to wait for |
DIRECT pushes the locked visit into your EDC as an attributed entry. Sponsor eSource reads the live record from the first visit.
The investigator locks the visit. That version, with its fingerprint, is what leaves the site.
Each question is mapped to the sponsor's EDC field once, approved, and reused for every subject.
DIRECT writes the locked visit into the sponsor's EDC, attributed to the person who entered it.
A correction is a new locked version with its reason, sent the same way. Nothing is overwritten.
Password at every signature, the signer's printed name, date, time and meaning, recorded with the record.
A code by email at every sign-in, account lock after repeated failures, automatic sign-out when idle.
Who changed what, when, from where and why, for every record, readable by the people who need it.
Separate instances for the United States and Australia, with Europe to follow. Your data never leaves the region you choose.
Each application has its own website. Here is how they fit together.
Use it as your eSource and site CTMS for every study you run. No license, no per-seat fee.
DIRECT pushes the locked visit into your EDC as an attributed entry. Sponsor eSource reads the live record from the first visit.
Sites use smartSOURCE free. Choose your region to sign in, or talk to us about the applications for your site.