Software and AI for clinical research
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Clinical research

Software and AI for clinical research

Clinical trials are complex, regulated and critical processes. We build software that accelerates participant recruitment, digitises data capture (eCRF), enables remote patient follow-up and guarantees GCP, 21 CFR Part 11 and GDPR compliance at every step.

“For research teams where one badly captured data point can invalidate years of work.”

50+Studies digitised
1,000+Patients recruited
25%Reduction in recruitment time
100%Data in the EU, GCP compliant
The real problem

What holds companies back
de este sector

Patient recruitment is the bottleneck

Eighty per cent of clinical trials are delayed by recruitment problems. Inclusion and exclusion criteria are complex, eligible patients are scattered across sites, and screening is manual.

The sponsor's eCRF does not fit the investigator's workflow

The principal investigator has to interrupt the consultation to enter data into a system designed by the sponsor, which knows nothing about their workflow. The result is data entered hours later, with errors and without context.

The audit arrives when nothing can be fixed

Monitor queries appear weeks after the visit. By then the investigator no longer remembers the missing detail, and the documentary amendment costs more than doing it right in the first place.

Use cases

What we build
para este sector

Automated screening and recruitment platform

The system cross-references the protocol's inclusion and exclusion criteria against EHR data to identify eligible patients automatically. The investigator gets a filtered list; the patient, a personalised invitation.

Adaptive eCRF with real-time validation

Forms that adapt to the trial protocol. Range checks, cross-visit consistency and protocol checks at the moment of data entry. Queries are raised instantly, not weeks later.

Remote patient follow-up app (PRO)

Patients report symptoms, quality of life and treatment adherence from their phone. The data reaches the eCRF directly, timestamped and with no intermediaries. Ideal for decentralised trials.

Monitoring portal for CROs

The trial monitor sees the status of every site in real time: enrolment, open queries, pending visits and protocol deviations. The monitoring visit is prepared on data that is up to the minute.

Capabilities

Solutions we deliver

eCRF platforms for electronic clinical data capture
Patient recruitment and screening systems
Remote follow-up and PRO (Patient Reported Outcomes) apps
Portals for investigators and trial monitors
Integration with EDC systems and central laboratories
AI to identify trial candidates in EMR databases

Regulatory compliance

Our clinical research platforms comply with ICH E6(R2) GCP, 21 CFR Part 11 for electronic signatures and records, GDPR for participant data and the computerised system validation requirements of EMA Annex 11.

Services applied

Technology we use en este sector

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IA aplicada

Inteligencia artificial para empresas

Consultoría e implantación de IA para empresas: agentes de IA, automatización, asistentes con tus documentos y visión artificial. Del diagnóstico a producción.

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Software

Desarrollo de software a medida

Construimos aplicaciones y plataformas digitales adaptadas exactamente a tus procesos y objetivos de negocio.

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Integraciones

Integraciones & APIs

Conectamos tus sistemas y aplicaciones para crear flujos de trabajo automatizados y eficientes.

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Frequently asked questions

Everything you need to know

Do you comply with 21 CFR Part 11 and GCP?
Yes. Our clinical research platforms implement electronic signatures, complete audit trails, software validation and access controls that meet 21 CFR Part 11 and the ICH GCP guidelines.
How do you guarantee trial data integrity?
We build ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate) into the system design, with immutable audit records and real-time data validation.
¿Trabajas en clinical research?

Tell us your challenge.
We design the solution together.

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