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Healthcare & Enterprise
Patient RecruitmentHIPAA CompliantCTMS Integration

臨床試験ウェブサイト開発

適格患者が登録される前に試験募集が停滞していないか

3×
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.

プロジェクトが失敗する理由

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The site finder is broken or outdated, routing patients to closed locations Qualified candidates abandon enrollment the moment they can't find a nearby participating site.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

コンプライアンス

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.

構築する内容

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

私たちのプロセス

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

よくある質問

臨床試験ウェブサイトの構築にはどのくらいの期間がかかりますか?

ほとんどの臨床試験サイトは8～12週間で起動します。これはCTMS統合の複雑さと必要な適格性スクリーナーの数によって異なります。eConsentなしの単純な単一研究サイトは6週間で配信可能です。EDC統合を備えた多研究スポンサープラットフォームは通常10～14週間かかります。

既存のCTMSプラットフォームと統合できますか?

はい。Medidata Rave、Veeva Vault、Oracle Clinical、Medrioとの統合を構築してきました。CTMSがREST APIまたはSOAP APIを公開している場合、接続できます。認証、データマッピング、エラー処理を処理し、患者データが試験管理システムに直接流入するようにします — 手動再入力はありません。

ウェブサイトはHIPAA準拠ですか?

当社が構築するすべてのサイトはアーキテクチャレベルでHIPAA準拠です。BAA対象ホスティング、保存時と転送中のすべてのPHI暗号化、ロールベースのアクセス制御、完全な監査ログを使用します。HIPAA準拠ドキュメンテーションはサイト起動時に配信されます。

eConsentと電子署名をサポートしていますか?

当社が構築するeConsentワークフローは21 CFR Part 11要件に適合しています — 本人確認、タイムスタンプ付き監査証跡、マルチメディア教育コンテンツ、理解度チェック、法的拘束力のある電子署名。完全な同意プロセスは文書化され、FDA検査用にエクスポート可能です。

開発者なしで臨床オペレーションチームがサイトを更新できますか?

はい。SanityなどのヘッドレスCMSプラットフォームで構築しているため、チームはビジュアルエディタを通じて適格性基準、サイト場所、研究資料、ページコンテンツを更新できます。変更はすべての言語で即座に公開されます。開発者チケットなし、プロトコル変更時の遅延なし。

患者募集のコンバージョン率をどのように改善しますか?

登録ファネルのすべてのステップをプライバシーを尊重した分析で計測します — スクリーナー完了率、サイトファインダーの使用状況、同意ドロップオフポイント。起動後、スクリーナーUX、ランディングページコピー、CTA配置に関するA/Bテストを実施して、適格な登録ボリュームの向上を継続します。

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

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