CONTRACT RESEARCH ORGANIZATION (CRO) · DOES IT FIT US?

SOP, CSV, audit:
evidenced and reviewable.
Your trial systems remain untouched.

traqx prepares SOP, system-validation and audit work inside a defined source room — as a Word file with tracked changes and source comments that your experts review and decide on. CTMS, eTMF, EDC and clinical data stay in their responsible systems.

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WHAT YOUR TEAM GAINS

Quality work alongside running trials — without touching your systems.

CTMS, eTMF and EDC remain untouched
traqx works on SOPs, validation and audit documents — not inside your trial systems.
Answers with evidence
Quality questions are prepared with evidence from project and sponsor records.
Assessment stays with your experts
traqx prepares; professional assessment and decision stay with the responsible expert.

THREE CONCRETE SITUATIONS

How traqx prepares groundwork in CRO quality work.

Agent work remains limited to internal quality processes and provided sources — trial operations and clinical data stay in their systems.

01Review an internal QMS SOP against a selected ICH E6(R3) requirement

CONTROLLED INPUTSInternal quality SOP, CRO policy, current template, controlled ICH E6(R3) source and documented reason for change.

WHAT TRAQX DOESSOP Agent · Compares the SOP, internal requirements and the selected external source and prepares a justified revision.

REVIEWABLE RESULTThe reviewed QMS SOP as a Word file — every change tracked and commented with source and rationale.

WHAT YOUR TEAM DECIDESThe CRO expert determines applicability and interpretation and releases the SOP in the organisation's own quality process.

02Prepare documentation for a system that actually requires validation

CONTROLLED INPUTSSystem requiring validation, approved validation plan, process description, supplier documentation and test evidence.

WHAT TRAQX DOESValidation Agent · Compares requirements, risks, tests and traces within the defined system and validation scope.

REVIEWABLE RESULTDeltas, a gap list, and requirement, test and traceability candidates.

WHAT YOUR TEAM DECIDESThe validation expert assesses and decides; traqx does not replace CTMS, eTMF or EDC and does not manage clinical data.

03Answer one concrete quality question from project and sponsor documents

CONTROLLED INPUTSProject and sponsor documents for the documented quality question, approved internal records, marked source status.

WHAT TRAQX DOESAudit Agent · Researches inside the provided files and separates evidenced answers from missing evidence and open questions.

REVIEWABLE RESULTCited answer draft, evidence list and clearly identified open points.

WHAT YOUR TEAM DECIDESThe CRO expert reviews the answer; this creates neither a sponsor portal, trial control nor clinical data management.

traqx works on the quality work object — trial management, the trial master file and clinical data remain in their responsible systems.

01SCOPEBound quality and project sources
SOPs, policies, templates, provided sponsor documents and guidance are selected for the work object.
Result · defined quality context
02GENERATEPrepare research, draft or update
traqx works only inside the defined source room and prepares reviewable groundwork.
Result · source-bound suggestion
03VERIFYCheck evidence passages, status and gaps
Source references and open points remain visible; no management as clinical data or trial records.
Result · visible work state
04REVIEWLet quality experts review and decide
The responsible experts correct, accept or reject within the existing quality process.
Result · human decision

FIT / BOUNDARY

A fit for internal CRO quality work. Not for trial or data operations.

The boundary protects against a false product picture and unsupported inference of GCP capabilities.

✓ FITS

SOP, CSV, audit and quality-document work

The contract research organization defines sources and quality scope, needs reviewable groundwork and retains subject-matter assessment and decision with the responsible expert.

— DOES NOT FIT AS

CTMS, eTMF, EDC, LIMS or trial management

traqx does not manage trial operations, clinical data or laboratory processes and promises no sponsor or trial portal.

EVIDENCE, NOT A MARKETING CLAIM

Inspect source and review logic without a trial-platform promise.

traqx is EU-hosted and works in controlled source rooms; customer documents stay within the agreed tenant and hosting scope and are not used for model training. Experts review and decide. The product dossiers show real system views with synthetic demo data—not CRO customer outcomes.

View practice case & product dossiers →Trust System →

VISIBLE PRIMARY SOURCE

GCP context is used only where it actually applies.

ICH · E6(R3) Good Clinical Practice
ICH E6(R3) is the international ethical, scientific and quality standard for trials involving human participants. On this page, it establishes no CTMS, eTMF, EDC or trial-management capability for traqx.

FAQ

CRO fit remains bounded to quality work.

Is traqx a fit for quality work in a contract research organization—and does it replace a CTMS, eTMF or EDC?

traqx fits a contract research organization's internal quality, SOP, system-validation and audit work when project or sponsor documents are used as sources inside a defined work context. traqx does not replace a CTMS, eTMF, EDC or LIMS and performs no trial management or clinical data management.

Can traqx use sponsor documents as sources without being a sponsor portal?

Yes. Provided sponsor or project files can serve as controlled sources inside a defined work object. That does not imply a sponsor portal or CTMS or eTMF integration.

How does traqx work with an existing Word SOP in the CRO QMS?

traqx can revise the SOP against approved internal and external sources and return it as a Word file with tracked changes, source and rationale comments, and an updated version history. Review and release remain in the CRO QMS.

Does traqx manage clinical trials or clinical data?

No. This page promises neither trial management nor CTMS, eTMF, EDC or LIMS functions. traqx prepares quality and document work inside the defined source room; experts review and decide.

SOP, CSV, audit:evidenced and reviewable.Your trial systems remain untouched.

Quality work alongside running trials — without touching your systems.

How traqx prepares groundwork in CRO quality work.

Mapped traqx use cases for this industry.

SOP management

Audit readiness

Change Control

CAPA

Supplier Assessment

CSV / CSA

IT infrastructure qualification

Equipment qualification

Defined quality sources in. Reviewable groundwork out.