Skip to main content

Clinical Trials

Less stack. More trial.

  • Turn the protocol into a working study.
  • Keep sites and participants on protocol.
  • Build the analysis while the study runs.

Electronic data capture with the work around it in the same system: start-up and site onboarding, eConsent and the participant portal, payments, devices and biospecimens, monitoring, and a workspace where the protocol becomes the study and the data come back into the report. 21 CFR Part 11 controls and an audit trail across the study.

Book a 5-minute fit check

Bring the protocol. We’ll show you what start-up looks like.

See our research partners

Built for the trials that shouldn’t need six vendors.

Multi-site trials, sponsored studies, device studies with wearable data, and registries that sit next to trials.

MediciNova · Napo Pharmaceuticals · Aoti · SMART-BD · Diabetes 2 Discovery · TRUST

What you don’t have to buy next.

eConsent, ePRO, payments, devices, specimens, and analysis are often separate products. In Studytrax, they’re part of the same research environment.

eConsentConsent and re-consent, with signatures
ePROParticipant portal and outcomes from home
Participant paymentsIssued automatically when a visit is done
Device dataWearables and external devices
BiospecimensBiotrax: collection, tracking, storage
Analysis and writingDatasets, tables, reports, manuscripts
Studytrax
Built in, not bolted on.
One participant record·One audit trail·One login

Six workstreams. One record.

Start-up and sites.

Protocol to schedule, roles, SOPs, training materials, multi-site access.

Participants.

eConsent, the Study Portal, reminders, patient-reported outcomes, messaging, payments.

Capture.

Staff forms, validation as data are entered, queries, source verification, external data.

Devices and samples.

Wearable and device feeds, and Biotrax specimens tied to the clinical record.

Oversight.

Adverse events, monitoring, audit trail, study documentation.

Analysis and reporting.

Datasets, tables, on-demand reports, and the writing workspace.

Start-up. Protocol in, study out.

The build doesn’t start from a blank database. The protocol and schedule go in; forms, visit windows, branching, notifications, and site access come out, drafted with AI in days rather than weeks and reviewed with you before anything opens.

A repeatable path.

The same start-up sequence every time, with people who have run it hundreds of times available when the protocol does something unusual.

Sites, onboarded.

Role-based access per site and per study, with SOPs and training materials available to each site the day it opens.

eConsent, configured.

Consent versions, signatures, and re-consent in the portal, with the audit trail already in place.

Reviewed before the first participant.

The AI drafts; your team and ours walk the study end to end before it opens. Nothing goes live unreviewed.

Conduct. Both sides of the trial. One record.

The study team runs the trial. Participants experience it. Studytrax connects both.

Study teamBuild, monitor, and analyze
StudytraxOne participant record
ParticipantEngage, complete, and stay in
Start-upWeeks 0 to 6
Protocol to schedule
Sites activated
Staff trained
Learn about the study
Screened online
Portal account created
EnrollmentBaseline
Baseline forms
Eligibility confirmed
Randomized
eConsent on phone
Baseline PROs from home
Know what’s next
Visit 2Month 3
Visit forms
Specimen collected
Query resolved
PROs completed at home
Device data synced
Payment issued
Visit 3Month 6
Adverse event logged
Device data reviewed
Interim table updated
PROs completed at home
Message to coordinator
Payment issued
Close-outMonth 12
Data lock
IRB report generated
Manuscript tables
Final visit
Final payment issued
Study complete
One participant recordClinic data·PROs·devices·specimens·payments·queriesNothing re-keyed. Everything stays connected.

Sites.

Staff enter at the visit; queries and source verification run in the same place; adverse events log against the visit they happened in.

Participants.

One account for consent, reminders, outcomes from home, and messages to the coordinator. Payments issue when a visit or form is complete, without a spreadsheet.

Devices and samples.

Wearable and device readings land on the participant’s record next to the visit. Biotrax records each specimen against the same subject and visit, collected on the study schedule.

Results. Build the analysis while the study runs.

The protocol, the study, and the report live in one loop, and the analysis doesn’t have to wait for collection to end. Datasets, tables, and reports are built and validated during the study, then rerun against the right data at cutoff. Safety summaries, progress reports, and IRB reports come from the live study rather than being assembled by hand. Teams use the same reports to prepare DSMB packets.

Protocol
Design
Schedule, forms, arms, randomization, consent, IRB package
Studytrax
Run the study
Sites, participants, visits, PROs, devices, specimens, queries
Studytrax
Live data
Clean, monitored data ready for analysis
Report
Results
Tables, figures, safety summaries, progress reports, manuscript

The next protocol starts from everything this one produced.

Previous protocols, the live study, and the write-up don't sit in three tools. They're connected in Studytrax.

If you’re running a drug trial.

Visits and windows, arms and randomization, adverse and serious adverse events, queries, multi-site monitoring, and safety reporting from the live data.

If you’re running a device study.

Device and wearable streams, procedure plus follow-up schedules, specimens, long follow-up, and patient-reported outcomes from home, with sites that may have thinner research infrastructure.

Same platform. Same fit check.

Compliant by default.

21 CFR Part 11 audit trail and electronic signatures. HIPAA, with a BAA. Role-based access scoped per study and per site. One compliance posture across the trial, the portal, the devices, and the samples in Biotrax.

Compliance

Bring us your protocol.

We’ll show you how it becomes a working Studytrax study.

Book a 5-minute fit check