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InBiotek Data Web Services

IDWS integrates the capture, management, and central monitoring of clinical trial data into a single platform, from patient enrollment to follow-ups, procedures, adverse events, and queries.

FHIR® native
Clinical information is structured from the outset using an international standard, facilitating its integration with hospitals, laboratories, devices, and other systems without relying on closed data models.

AI agents on clinical data
Specialized agents continuously analyze data incorporated into the study to detect omissions, inconsistencies, outliers, and potential protocol deviations. These agents calculate quality and risk indicators, prioritize sites and patients requiring review, and generate alerts and query proposals for the monitoring team.

Each finding remains traceable and is reviewed by qualified personnel. IDWS doesn't just store data: it transforms it into concrete monitoring priorities.

Automatic anonymization layer

The IDWS anonymization agent processes any clinical dataset that may contain personal information, operating in accordance with ISO 14155 standards and the General Data Protection Regulation (GDPR).

  • Automatic pseudonymization and anonymization according to data sensitivity level.
  • Compatible with multicenter studies and exports to sponsors and regulatory authorities.
  • Fully auditable process: all events are logged in the InBiotek QMS log.

Guarantee that no identifiable data is processed outside of authorized environments.

Remote central monitoring

An integrated monitoring agent in the IDWS performs systematic and continuous reviews of the study database, configured with the protocol's validation criteria.

  • Real-time active detection of discrepancies in the study's baseline data.
  • Proactive identification of inconsistencies, outliers, and protocol deviations.
  • Significant reduction in on-site monitoring visits, saving the developer cost and time.

Structured monitoring reports ready for the Trial Master File (TMF).

AI in each phase of the study

01 Study Documentation

  • Protocols, CIP, and economic reports
  • Adapted informed consents
  • MDR / RD 1090/2015 / AEMPS Adaptation

Version control with terminological consistency

02 Analysis and reports

  • Automated tracking reports
  • Descriptive and Inferential Statistical Analysis
  • Executive Summaries for the Developer

Presentations for CEIMs and funders

 

03 Study Design and Feasibility

  • Literature review for scientific justification
  • Benchmarking with competitor studies
  • Item budgeting and schedule

Feasibility assessment for new indications

04 Quality and Compliance

  • Review and update of QMS SOPs
  • Responses to AEMPS / ISCIII requirements
  • Preparation of internal and external audits

Corrective action tracking (CAPA)

05 Data Management (eCRD+)

  • Real-time multi-center databases
  • Integrated FIHRM validation in each record
  • Patient-Device-Center Traceability

Walkways with hospital systems and records

06 Stakeholder Communication

  • Materiales de captación de centros e IPs
  • Propuestas comerciales y pitches a sponsors
  • Comunicaciones periódicas a centros participantes

Materiales de divulgación científica

InBiotek vs. CRO tradicional

CRO tradicional

Equipos grandes con tareas compartimentadas

3-6 semanas por protocolo

Presupuestos elevados por overhead estructural

Interlocutores múltiples, difusión de responsabilidad

Extraccion manual de datos de documentos clinicos

Monitorizacion presencial o revision manual periodica

InBiotek con IA

Equipo ágil con capacidad documental amplificada

Primera versión en 48-72 horas

Costes competitivos sin merma de calidad ISO

Interlocutor único con visión integral del estudio

Captura automatica con InBioREG AI + validación FIHRM

Monitorización central remota continua con agente IA

La IA como herramienta: el criterio experto siempre prevalece

La integración de IA en los procesos de InBiotek se realiza con plena responsabilidad hacia los pacientes, los investigadores y los organismos reguladores.

Revision humana 100 %

Todo output de IA es validado por personal cualificado antes de su uso.

ISO 9001 · ISO 14155

El SGC de InBiotek aplica íntegramente a los flujos con IA, sin excepción.

RGPD compliance

Los datos de pacientes se procesan siempre anonimizados. Ningún dato personal se introduce en herramientas IA externas.

Decision clinica humana

Las decisiones clínicas y regulatorias son siempre responsabilidad del equipo investigador y de InBiotek.

Trazabilidad completa

Todos los procesos con IA quedan documentados y son auditables en el marco del SGC.