From the eCRF builder to the database lock: everything a study needs, in one portal and already working. The most important first; every picture is a live screen of a demo study with invented data.
Two short videos of a demo study with captions: from signing in and a new study to the query, the SDV and the investigator’s signature.
Forms, fields, edit checks, answer lists, languages, ePRO screens and the visit schedule in one builder. You build the eCRF in the study's QA environment, try it on test patients, and the live study receives every change as a version, like a protocol amendment.
The site enters the visit, the checks fire as soon as it is saved. Next to the form you see its state: SDV, the data manager's approval, the lock, open queries. Every action is a button with a clear label.
Sex, age, status, open queries and the timeline of visits with their windows: what is done, what is due, what is overdue. From here also the certified copy of the casebook as a PDF and data from the medical record.
Phase, design, population, countries and the enrolment plan in the study passport. Below it, a line from the first patient to the database lock and the report: where the study is today and how far it still has to go.
Questions from automatic checks, monitors and data managers in one list, with the site, the source and the age. Standard query texts, filters by age and site, closing several at once with a reason.
The form is filled in, the monitor verifies it against the source, the data manager approves it. Every step is visible per study, site and patient, in numbers and percentages.
The investigator signs the whole patient with their password. Any later change withdraws the signature, and the patient returns to the “Sign again” list by itself.
Lock clean forms one by one or thousands at once, for example before an interim analysis. The data can no longer change, while queries, SDV and signatures go on; every lock is a record in the audit trail.
Append only: every record is chained to the previous one by a hash, each study has its own chain. The “Check integrity” button shows that nobody has edited the trail. Export to CSV for the inspector.
The portal finds patterns in the audit trail worth a look: data entered at night or long after the visit, changes after the visit. Critical data first; a signal is not a finding, it is a reason to check.
Excel with a sheet per form and a dictionary, CSV for SAS, Stata, R and Python, CDISC ODM 1.3.2 for other systems. Next to it you see what still stands in the way of the lock, and every export is recorded in the audit trail.
Minimisation (Pocock–Simon) or stratified blocks. The scheme is signed before the start, the randomisation log and the balance by site are visible at once, emergency unblinding only with a reason and an audit record.
Patients fill in questionnaires and diaries on their own phones. You see who answers on time, who drops out and what to do now; the patient's access and reminders are on their card.
Completeness of every variable by site, outliers, entry delay, lost and withdrawn patients. All of it before the interim analysis, not after.
Signals starting with the most important, unusual values, often empty fields, trends, cuts and a report for the sponsor. It works on a data delivery from your EDC, and the queries come out as a file for it.
Enrolment, visits, entry delay, open queries, SDV, clean patients, serious AEs, with trend lines and a split by site. Every number opens down to the patients and records.
YouEDC Biostat on live data: who takes part, how the key variables change by visit, adverse events, curves and outliers by patient. A PDF report in one click. It is descriptive statistics: it does not replace the analysis by the statistical analysis plan.
The study in numbers for the sponsor and the team: enrolment, visits, forms, queries, SDV, by site. The portal makes it on a schedule, keeps every report and sends it to the chosen members of the team.
The lock checklist, readiness in percent, the forecast date at the current pace and what blocks it first. The report for the lock meeting is one button away.
Terms are coded the moment the site saves the form: what the dictionary codes by itself is coded at once, the rest waits for the team's decision. Licensed dictionaries (MedDRA, WHODrug) are attached under your licence.
Serious adverse event cases, Day 0 and deadlines, reports to authorities and ethics committees, literature, signals and the DSUR. A case from the EDC reaches YouEDC Safety without retyping.
Each site's data are compared with the other sites by standing statistical tests. A finding is a question for the monitor, not a verdict on the site.
Key risk indicators of every site, thresholds and the history by week (the ICH E6(R3) approach). The SDV sample and the monitoring plan follow the site's risk level.
Critical-to-quality factors, scored risks, control measures and quality tolerance limits. The assessment is signed in versions, and the next review is on the calendar.
The month's calendar: visits done, open windows and overdue visits across all your sites. Visit reminders come in advance.
Versions of the consent form and the list of patients who still have to sign the new one. Electronic consent adds remote signing, comprehension questions and a talk with the doctor.
Adverse events, out-of-range labs and therapy of every patient as the sites enter them. A row that changed after the review comes back to the medical monitor by itself.
The portal computes the response from the lesions the site entered, compares it with the investigator's answer and shows the mismatches worth a query at once.
The endpoint committee classifies the events blind to treatment: two independent assessments, and an arbiter when the experts disagree.
The open part on all patients and the closed part by treatment group, for the committee only. Each part is frozen as a PDF with a SHA-256 fingerprint.
The site uploads copies of source documents without personal data, the monitor verifies them from the office. Once the visit is checked the copies are deleted; only the record of what was shown remains.
The data manager prepares one change for many records, each site checks its records against the source and confirms. Every change is in the audit trail with the request number.
A cut freezes all the study data at one moment: for an interim analysis, a registry report or a publication. A year later it gives the same file, and SHA-256 proves it.
On a schedule: in full or only the changes, on the portal or to an SFTP server, to the statistician, the DSMB or the medical monitor. Every file is made from a frozen cut.
Upload the AE, therapy, visit and patient listings from any EDC, and the portal runs the typical cross-form checks that are hard to program in the EDC itself, with an Excel report.
The SAE listing from the safety database against the AE listing from the EDC: missing SAEs, mismatches in dates, outcomes and seriousness. The previous round's report carries over your statuses and comments.
Essential documents by the zones of the TMF Reference Model: completeness, filed on time, quality control, expiring documents and copies for the sites.
Where every kit is: at the depot, in transit, at the site or with the patient. Shipments, returns and destruction, batch recalls and drug accountability.
Site status and activation, enrolment against the plan, monitoring visits with their reports, action items and protocol deviations, in YouEDC Trials, next to the study data.
Budget, earned, invoiced, paid and withheld, by the study's fee schedule. Statements and advances are visible for every site.
A living DMP draft from the study's own data: what the portal knows, it fills in. A version is issued with signatures, with the differences from the last one and an export to Word.
The study is validated in its own QA environment: the validation documents are made with one button, downloaded as a ZIP or filed in the TMF. What the portal does and what stays yours is said plainly.
A paper form is typed by two people: the second types the same paper into an empty copy without seeing the first entry. The data manager settles differences against the paper; matches go through by themselves.
A tube is taken at the site, packed into a shipment with a manifest, received by the laboratory and checked against its results. You see at once what waits for shipment, what is on the way and what got lost.
A study scale is filled only by a rater with a valid certificate. When a certificate is later revoked, the form lands on the list to check by itself.
Glucometers, blood pressure monitors, step counters: the site uploads the file the device's program exports, and the portal takes the time and value of each reading and checks the range.
The investigator uploads the laboratory PDF, the portal proposes the values for the form, a person confirms or corrects them. You see where a site changed things by hand; the PDFs themselves are not stored.
A public recruitment page with a pre-screening questionnaire: who may fit, whom to call, who is booked for screening. The leads' data are deleted on time.
For a district hospital or a home visit: keep blank forms of your patients on the device and fill them in on the spot. The forms wait on the device encrypted and go to the server once there is a network.
One button makes a study with patients, visits, queries, safety cases and DM tasks. All invented but realistic: try every section before you start your own.
Create an account and make a demo study in one click: patients, visits, queries and safety cases are ready, so you can try each screen from this page.