Taru.one Taru.one

Screening and pre-dose eligibility workflow

A screening and pre-dose eligibility workflow system for Phase 1 clinical trials. From a volunteer’s first consent to Ready for Dosing, every eligibility conclusion is made by the right person, on the evidence, signed, and recorded in a way an inspector can follow.

The right people. The right evidence. The right decision.

Taru.one helps clinical trial teams screen, assess and document eligibility with confidence.

  • ConfidenceEvery eligibility conclusion is signed by the person who made it.
  • AccuracyAnswers are checked against permitted values, and every state change against the compatibility matrix.
  • CollaborationQC queries are discussed with clinicians, in a thread on the exact item.
  • Better outcomesSubjects reach dosing on a complete record an inspector can follow.

Foundations

Five principles everything else rests on

  • Two states, kept apart

    Operational workflow is separate from eligibility

    Each subject carries two states: where they are in the process, and what has been concluded about their eligibility. A published compatibility matrix states which pairs may coexist, and every change to either is checked against it.

  • Clinical accountability

    Clinicians own every clinical decision

    Every eligibility conclusion is a human act by an authorised role, signed by that person. Taru.one lays out the evidence and checks the rules; it never reaches a clinical conclusion itself.

  • Immutable snapshots

    Every decision rests on a frozen record

    The criteria a decision was based on are frozen in a snapshot at that moment. A later change produces a new snapshot; the one the decision used is never altered.

  • Append-only auditability

    The record can be added to, never rewritten

    The audit trail is append-only, and the database itself refuses any edit or deletion. Each action records who did it and the role they held at that moment.

  • Deliberately narrow scope

    Screening and pre-dose eligibility, done thoroughly

    Taru.one does one part of a trial and does it in depth, from consent to Ready for Dosing. It works alongside the systems that run the rest of the study.

The screening path

From consent to dosing, one verified, authenticated step at a time

A subject moves forward only when a person signs a step off, with their electronic signature. Results arriving do not move anyone: someone has to judge them complete and usable.

  1. 1Pending Evaluation

    Moves on whenthe evaluation is signed off

  2. 2Pending Results

    Moves on whenresults are reviewed and accepted

  3. 3Screening Complete

    Moves on whenthe investigator records the eligibility decision

  4. 4Pending Pre-Dose Confirmation

    Moves on wheneligibility is confirmed before dosing

  5. 5Ready for Dosing

Built on those foundations

Clinical judgement, supported by the system

Most systems describe the rules. Taru.one checks them.

Electronic signatures

Decisions, evaluation sign-offs, results reviews and overrides are signed. The record shows who signed, when, and what the signature means.

When it happened, and when it was recorded

Taru.one offers a distinction between the moment an event occurred and the moment it was documented. A consent signing, a dosing or a call with a volunteer carries the time it actually happened, and the record shows separately when it was entered.

Safety asymmetry

Losing eligibility is immediate and unrestricted. Gaining it requires evidence: a decision is refused while required criteria are still unresolved.

Reasonable safety flags on vital signs

Vital signs outside reasonable limits are flagged automatically, whatever the protocol says. The flag is a system safety heuristic: it draws no clinical conclusion, but crossing the threshold makes a clinical review mandatory.

Corrections never erase

A same-day correction to an assessment needs a reason and keeps the values it replaced. Editing a communication keeps every earlier version; after a set period a change is a linked correction.

QC as a conversation with clinicians

A flag beside every piece of data opens a query on that exact item, discussed in a thread with the clinicians and tracked on one dashboard.

A query never decides anything itself. When it brings a clinical issue to light, the clinician may determine that the subject is not eligible, or that an assessment needs to be repeated.

Pauses that match how sites work

Deferral is the site pausing: the subject keeps their eligibility and resumes where they stopped. Optionally, withdrawal can be split by consent, so one kind requires re-consent and the other does not.

Reconsent, handled deliberately

When a new ICF version arrives, the team records what it means for subjects already enrolled: who must be informed, who must re-consent, and who cannot continue until they have. A new version alone puts no one on hold.

Secure by design

Taru.one follows current industry-standard security practice: every connection is encrypted, sessions close when left idle, sensitive credentials are encrypted at rest, and the administrator can turn on logging of access to personal data.

An audit trail built for review

Every stored value is shown under a plain name, never an internal code. A reference page explains what causes each kind of audit event, and the trail can be searched by volunteer, subject, study, event type, staff member or date.

Everything a screening unit expects

The day-to-day work, in one place

Volunteers

  • Searchable volunteer registry with photo, identity and contact details
  • A medical profile kept current during screening: medications, allergies, medical history, substance use, contraception
  • Medical entries are retired, never deleted, with their full history

Communications

  • Every phone call, email, text or visit with a volunteer, inbound or outbound, kept in one searchable log
  • Linked to the study the person is in, with tags such as Important
  • An entry made more than 24 hours after the exchange needs a reason and is flagged as a late entry; the administrator can adjust this window

Study setup

  • Studies, cohorts and versioned protocols: draft, active, superseded
  • Inclusion and exclusion criteria per protocol version, including parent and sub-criteria
  • Cohort targets, places filled, and a dosing-calendar timeline

Screening

  • Enrolment of a volunteer into a cohort
  • BMI Verification, Medication Review, Medical Conditions Review, Vital Signs, ECG, Laboratory Results Review
  • Criteria review, with every answer and every change to it recorded
  • Screening and Day -1 data kept apart, never mixed

Consent

  • Versioned Main ICF documents per study
  • Signing records per subject
  • Consent status gates every protocol action

People and access

  • Admin, PI, Sub-Investigator, Subject Safety Reviewer, Clinical Study Manager, QC, Screening Staff
  • Every change is checked against the user’s role
  • Two-factor sign-in, which the administrator can require for any account

Reporting

  • Audit search built for monitors and inspectors, with a plain explanation of every kind of event
  • CSV export of the audit trail and of QC queries
  • Query age in days on every list and export

Scope

Focused on screening, and built to fit in

Taru.one covers

  • Volunteer onboarding, consent, medical profile and communications
  • Enrolment into cohorts and screening assessments
  • Structured eligibility review and signed decisions
  • Day -1 pre-dose confirmation through Ready for Dosing

Works alongside your other systems

  • Your EDC and CTMS for post-dose study conduct
  • Your safety systems for AE / SAE and pharmacovigilance
  • Your clinicians for every diagnosis and eligibility conclusion

Interested in Taru?

Demonstrations are available on request - contact us.

If the link does not open your email, write to us at info at taru dot one info at taru dot one