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Healthcare & Enterprise
Patient RecruitmentHIPAA CompliantCTMS Integration

Desarrollo de Sitios Web para Ensayos Clínicos

Tu Reclutamiento de Ensayos se Detiene Antes de que los Pacientes Calificados se Inscriban

Recruitment Velocity
vs. legacy trial sites
95+
Lighthouse Score
Performance target
<2s
Time to Interactive
Mobile-first builds
0
Compliance Gaps
HIPAA + 21 CFR Part 11
What Clinical Trial Website Development Actually Delivers — And What Generic Healthcare Sites Can't

A qualified patient lands on your trial page. They tap through a branching screener that checks inclusion criteria in real-time. The system routes them to the nearest participating site, surfaces a video consent explainer, captures their eSignature with a 21 CFR Part 11 audit trail, and syncs everything to your CTMS before your site coordinator even opens Slack. That's clinical trial website development — the engineering discipline that turns recruitment media spend into enrolled participants. Your stack handles patient screening, informed consent workflows, site finder geolocation, and bi-directional data exchange with Medidata, Veeva, or Oracle Clinical. Unlike generic healthcare sites, your platform must satisfy FDA, HIPAA, and ICH-GCP requirements while converting visitors into protocol-qualified enrollees. Every month of delayed recruitment burns $600K to $8M depending on therapeutic area. Your site is either accelerating enrollment or quietly costing you the trial timeline.

Dónde fallan los proyectos

Patient recruitment timelines are slipping because your trial website performs poorly on mobile Each month of delayed enrollment costs $600K–$8M depending on therapeutic area.
Your current site lacks structured eligibility screeners, so call centers end up fielding unqualified leads 80% of screener calls are wasted on ineligible patients, burning through budget and staff time.
Consent forms are static PDFs with no audit trail FDA auditors flag missing documentation under 21 CFR Part 11, which puts trial validity at risk.
The site finder is broken or outdated, routing patients to closed locations Qualified candidates abandon enrollment the moment they can't find a nearby participating site.
Every protocol amendment requires a developer to update the site Delays in refreshing eligibility criteria or site information create real compliance exposure.
There's no visibility into where patients drop off in the enrollment funnel Recruitment media spend continues with no data on what's actually working.

Cumplimiento

HIPAA-Compliant Architecture

All patient data is encrypted at rest and in transit using BAA-covered infrastructure. No PHI touches client-side storage or third-party analytics.

21 CFR Part 11 Audit Trails

Electronic signatures and consent workflows generate timestamped, immutable audit logs. Every interaction is traceable and ready for FDA inspection.

Accessible by Default (WCAG 2.2 AA)

Clinical trial sites need to reach diverse populations, including people with disabilities. We build to WCAG 2.2 AA from day one — not as an afterthought.

Multi-Language Support

Locale-aware content delivery helps you reach patients across demographics and geographies. CMS-driven translations ensure protocol amendments push across all languages at once.

Real-Time Enrollment Analytics

Privacy-respecting analytics show exactly where patients exit the screening funnel. You get clear data to guide recruitment spend — without touching PHI.

Edge-Deployed Performance

Sites load in under 2 seconds globally via edge CDN. That speed directly improves screener completion rates, particularly on mobile in underserved areas.

Qué construimos

Route unqualified leads into branching screeners that check inclusion/exclusion criteria before they ever reach your call center

Branching logic questionnaires pre-qualify patients against your protocol before site staff waste time on ineligible calls

Replace static PDF consent forms with digital workflows that capture comprehension checks, eSignatures, and complete audit trails

Geocoded site search with real-time availability updates drives qualified candidates to the nearest open location with one tap

Fix broken site finders that route patients to closed locations or outdated contact information

Bi-directional API connections sync patient data between your trial site and Medidata, Veeva, or Oracle Clinical without manual entry

Eliminate developer bottlenecks every time a protocol amendment requires updated eligibility language or new site listings

Headless CMS lets your clinical operations team update criteria, site info, and study materials the moment protocols change — no code required

Stop running recruitment media campaigns with zero visibility into where patients abandon the enrollment funnel

eConsent engine delivers multimedia explainers, comprehension checks, electronic signatures, and full 21 CFR Part 11 audit trails in one workflow

End the compliance exposure that comes from missing 21 CFR Part 11 documentation during FDA audits

Recruitment landing pages built for A/B testing across Google, Meta, and programmatic channels with pixel-level conversion tracking

Nuestro proceso

01

Protocol & Compliance Review

We review your study protocol, ICF requirements, and existing CTMS stack. Eligibility criteria get mapped into screener logic, and we identify every compliance requirement upfront.
Week 1
02

UX Research & Architecture

Patient journey mapping, site architecture, and wireframes come next. We validate screener UX against real patient personas and build accessibility compliance in from the start.
Week 2–3
03

Design & Development Sprint

High-fidelity designs move into production Next.js code. CTMS integrations are built and tested in staging. The headless CMS gets configured for your clinical ops team.
Week 4–7
04

Compliance QA & Penetration Testing

We run a HIPAA security assessment, WCAG 2.2 AA audit, 21 CFR Part 11 validation, and third-party penetration testing. All findings are documented for your regulatory files.
Week 8
05

Launch & Recruitment Optimization

Deployment goes to edge infrastructure with full monitoring. You get 30 days of post-launch support, including screener funnel optimization based on live enrollment data.
Week 9–12
Next.jsSupabaseVercelSanity CMSCloudflarePostHog

Preguntas frecuentes

¿Cuánto tiempo tarda en construirse un sitio web para ensayos clínicos?

La mayoría de los sitios de ensayos clínicos se lanzan en 8–12 semanas, dependiendo de la complejidad de la integración CTMS y la cantidad de screeners de elegibilidad necesarios. Los sitios simples de un solo estudio sin eConsent pueden lanzarse en 6 semanas. Las plataformas patrocinadores multi-estudio con integraciones EDC típicamente requieren 10–14 semanas.

¿Pueden integrar con nuestra plataforma CTMS existente?

Sí. Hemos construido integraciones con Medidata Rave, Veeva Vault, Oracle Clinical y Medrio. Si tu CTMS expone una API REST o SOAP, podemos conectarla. Manejamos autenticación, mapeo de datos y manejo de errores para que los datos del paciente fluyan directamente hacia tu sistema de gestión de ensayos — sin re-entrada manual.

¿El sitio web cumple con HIPAA?

Cada sitio que construimos es conforme a HIPAA por arquitectura. Utilizamos hosting cubierto por BAA, encriptamos todo PHI en reposo y en tránsito, aplicamos controles de acceso basados en roles y proporcionamos registros de auditoría completos. La documentación de cumplimiento HIPAA se entrega con el sitio al lanzamiento.

¿Soportan eConsent y firmas electrónicas?

Construimos flujos de eConsent que cumplen con los requisitos de 21 CFR Parte 11 — verificación de identidad, registros de auditoría con marca de tiempo, contenido educativo multimedia, verificaciones de comprensión y firmas electrónicas legalmente vinculantes. Todo el proceso de consentimiento está documentado y es exportable para inspección de la FDA.

¿Puede nuestro equipo de operaciones clínicas actualizar el sitio sin desarrolladores?

Sí. Construimos sobre plataformas CMS headless como Sanity, para que tu equipo pueda actualizar criterios de elegibilidad, ubicaciones de sitios, materiales de estudio y contenido de páginas a través de un editor visual. Los cambios se publican inmediatamente en todos los idiomas. Sin tickets de desarrolladores, sin retrasos cuando cambian los protocolos.

¿Cómo mejoras las tasas de conversión de reclutamiento de pacientes?

Instrumentamos cada paso del embudo de inscripción con análisis respetuosos con la privacidad — tasas de finalización de screeners, uso del buscador de sitios, puntos de abandono de consentimiento. Post-lanzamiento, ejecutamos pruebas A/B en UX del screener, copy de landing page y ubicación de CTA para seguir mejorando el volumen de inscripción calificada.

Clinical Trial Sites from $12,000
Fixed-fee. Compliance documentation included. 30-day post-launch support.
See all packages →
Next.js DevelopmentHeadless CMS DevelopmentCore Web Vitals OptimizationCore Web Vitals & Jamstack Guide

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