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Healthcare & Enterprise

Patient RecruitmentHIPAA CompliantCTMS Integration

Desenvolvimento de Site para Ensaios Clínicos

Seu Recrutamento de Ensaio Estagna Antes de Pacientes Qualificados se Inscreverem

3×

Recruitment Velocity

vs. legacy trial sites

95+

Lighthouse Score

Performance target

<2s

Time to Interactive

Mobile-first builds

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.

Onde os projetos falham

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The site finder is broken or outdated, routing patients to closed locations Qualified candidates abandon enrollment the moment they can't find a nearby participating site.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.

Conformidade

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.

O que construímos

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

Nosso processo

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

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

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

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

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

Perguntas frequentes

Quanto tempo leva para construir um site de ensaio clínico?

A maioria dos sites de ensaios clínicos é lançada em 8–12 semanas, dependendo da complexidade da integração CTMS e do número de screeners de elegibilidade necessários. Sites simples de estudo único sem eConsent podem ser lançados em 6 semanas. Plataformas de patrocinador multi-estudo com integrações EDC normalmente levam 10–14 semanas.

Você pode integrar com nossa plataforma CTMS existente?

Sim. Construímos integrações com Medidata Rave, Veeva Vault, Oracle Clinical e Medrio. Se seu CTMS expõe uma API REST ou SOAP, podemos conectá-la. Lidamos com autenticação, mapeamento de dados e tratamento de erros para que os dados dos pacientes fluam diretamente para seu sistema de gerenciamento de ensaios — sem reentrada manual.

O site é compatível com HIPAA?

Sim. Cada site que construímos é compatível com HIPAA por arquitetura. Usamos hospedagem coberta por BAA, criptografamos todo PHI em repouso e em trânsito, aplicamos controles de acesso baseados em função e fornecemos logs de auditoria completos. A documentação de conformidade HIPAA é entregue com o site no lançamento.

Você suporta eConsent e assinaturas eletrônicas?

Sim. Construímos fluxos de trabalho de eConsent que atendem aos requisitos 21 CFR Part 11 — verificação de identidade, trilhas de auditoria com timestamp, conteúdo educacional multimídia, verificações de compreensão e assinaturas eletrônicas vinculantes. O processo completo de consentimento é documentado e exportável para inspeção FDA.

Sua equipe de operações clínicas pode atualizar o site sem desenvolvedores?

Sim. Construímos em plataformas CMS headless como Sanity, para que sua equipe possa atualizar critérios de elegibilidade, locais de sites, materiais de estudo e conteúdo de página através de um editor visual. As mudanças são publicadas instantaneamente em todos os idiomas. Nenhum ticket de desenvolvedor, nenhum atraso quando os protocolos mudam.

Como você melhora as taxas de conversão de recrutamento de pacientes?

Instrumentamos cada passo do funil de inscrição com analytics respeitosos da privacidade — taxas de conclusão de screener, uso de localizador de sites, pontos de abandono de consentimento. Pós-lançamento, executamos testes A/B em UX de screener, copy de página de destino e posicionamento de CTA para manter melhorando o volume de inscrição qualificada.

Clinical Trial Sites from $12,000

Fixed-fee. Compliance documentation included. 30-day post-launch support.

See all packages →

Next.js Development Headless CMS Development Core Web Vitals Optimization Core Web Vitals & Jamstack Guide

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