# Trialinx — Full Documentation for AI Systems > Trialinx is a clinical research data collection platform built for researchers, clinicians, and academic institutions. It combines a powerful form builder (**13 field types**), **5 AI-powered capabilities**, automated statistical analysis, and real-time collaboration — all in a HIPAA-ready environment with **AES-256 encryption** at rest and **TLS 1.2+** in transit. Founded by Dr. Xus Badia, colorectal surgeon, Barcelona, Spain. --- ## Overview Trialinx eliminates the need for spreadsheets, paper forms, and expensive enterprise EDC (Electronic Data Capture) software in clinical research. It is a SaaS platform accessible via web browser, requiring no installation or IT infrastructure. **Website:** https://trialinx.com **Founded:** 2024 **Founder:** Dr. Xus Badia (colorectal surgeon, Hospital de Barcelona, Spain) **Primary languages:** Spanish and English (bilingual platform, **2 languages**) **Target market:** Academic medical centers, hospital research departments, independent clinical investigators, pharmaceutical companies running early-phase trials --- ## Detailed Feature Documentation ### 1. Form Builder — 13 Field Types The Trialinx form builder provides a visual, drag-and-drop interface for creating clinical data collection instruments (CRFs — Case Report Forms). **Supported field types (13 total):** 1. `text` — Short text input (patient initials, notes) 2. `textarea` — Long text (narrative descriptions, adverse event descriptions) 3. `number` — Numeric input with optional min/max/decimal validation 4. `date` — Date picker (ISO 8601 format stored internally) 5. `date range` — Start and end date selection 6. `select` (single-select dropdown) — Predefined list of options 7. `multi-select` — Multiple selections from a predefined list 8. `radio` — Single choice from visible options 9. `checkbox` — Boolean true/false field 10. `checkbox group` — Multiple boolean selections 11. `repeater` — A group of fields that can be repeated N times (e.g., visit logs, medication lists) 12. `calculated` — Field whose value is computed from other fields using formulas 13. `markdown` — Display-only field for instructions/labels (no data entry) **Conditional logic — 5 comparison operators:** Fields can be shown or hidden based on values of other fields using 5 operators: equals, not_equals, contains, greater_than, less_than. Example: show "Specify other" text field only when "Other" is selected in a dropdown. **Randomization — 3 methods:** - Simple randomization - Block randomization - Stratified randomization **Form versioning:** Forms are versioned. Published forms cannot be edited retroactively; a new version must be created. This preserves data integrity for collected records. **Form library:** Users can save forms to a personal library and reuse them across studies. --- ### 2. 5 AI-Powered Capabilities #### 2.1 Conversational Study Design Researchers enter a natural language description of their study. The AI analyzes the study design (RCT, cohort, case-control, cross-sectional, etc.), identifies endpoints, generates a complete set of CRFs with appropriate field types and validation, and suggests standard scales (VAS, NRS, SF-36, ECOG, etc.) where applicable. Researchers can accept, modify, or reject any AI suggestion. **Supported study designs:** RCT, prospective cohort, retrospective cohort, case-control, cross-sectional, pilot/feasibility, registry, diagnostic accuracy study. #### 2.2 Automated Form Generation AI creates multiple validated data collection forms from a text description of the study. Forms include appropriate field types, validation rules, and conditional logic. #### 2.3 Statistical Analysis After data collection, the AI analysis engine processes collected data and generates: **Descriptive Statistics:** - Count, mean, median, mode, standard deviation, variance - Min, max, range, IQR - Frequency tables for categorical variables - Histograms and distribution summaries **Hypothesis Testing:** - Independent samples t-test - Paired t-test - Mann-Whitney U test (non-parametric) - Chi-square test and Fisher's exact test - One-way and two-way ANOVA - Kruskal-Wallis test **Regression Analysis:** - Simple and multiple linear regression - Binary logistic regression - Kaplan-Meier survival curves (for time-to-event data) - Cox proportional hazards model **Output formats:** - Interactive tables in the platform - Exportable PDF reports with methodology descriptions - Raw CSV export for use in R, SPSS, SAS, or Stata #### 2.4 AI Dashboard Creation AI automatically generates data visualization dashboards with KPI cards, tables, and charts based on the study data. #### 2.5 Analysis Chat (Natural Language Data Exploration) Conversational interface allowing researchers to explore their data using natural language queries. The AI answers questions about the collected data and generates on-demand analyses. **AI usage limits:** - Free plan: **1,000 AI runs per day**, **1M tokens per day** - Professional plan: **unlimited AI runs and tokens** --- ### 3. Subject Management **Subject enrollment:** Subjects are assigned a unique, anonymized study ID. No personally identifiable information (PII) is stored by default; PII linkage is managed by the research team in their own systems. **Visit scheduling:** Studies can define visit timelines. Data entry is associated with specific visits or timepoints. Repeatable forms support longitudinal study designs. **Query management:** Data queries (discrepancies or missing values) can be raised and resolved within the platform, with a full audit trail. --- ### 4. Collaboration — 3 Role Types **Roles:** | Role | Permissions | |------|-------------| | Viewer | Read-only access to dashboards and summary data | | Collaborator | View and fill forms, view own records, edit own records, view collaborators, view study details, view subjects | | Manager | Full study permissions: edit any record, manage collaborators, edit/delete studies, all collaborator permissions | | Owner | Full control including all manager permissions plus study deletion and ownership transfer | **Collaboration limits:** - Free plan: up to **10 viewers + 10 collaborators** per study - Professional plan: **unlimited collaborators** **Real-time collaboration:** Multiple users can work simultaneously on data entry. All activity is synchronized across collaborators. **Audit trail:** Every action is logged (see Security section for full details). --- ### 5. Security and Compliance #### Encryption - **At rest:** AES-256 encryption via Neon Postgres - **In transit:** TLS 1.2+ (HTTPS enforced on all endpoints) - **Database connections:** All database connections use encrypted SSL/TLS #### Authentication - Email/password with minimum requirements (8+ chars, uppercase, lowercase, number, special character) - Google OAuth and LinkedIn OAuth (optional) - **Two-Factor Authentication (2FA)** — TOTP-based, optional per user - Email verification required for all accounts - Sessions expire after 24 hours of inactivity #### Audit Trail — 7 Data Points, 11 Action Types, 13 Entity Categories **7 data points captured per audit log entry:** 1. User ID 2. Study ID 3. Entity type 4. Entity ID 5. Action performed 6. IP address 7. User agent + Timestamp (plus old values and new values for updates/creates) **11 action types tracked:** create, update, delete, publish, archive, invite, remove_member, change_role, sign, export, import **13 entity categories tracked:** study, form_definition, subject, form_record, dashboard, dashboard_card, data_source, study_member, ai_request, subscription, randomization_assignment, + 2 additional **Retention:** Audit logs are retained **indefinitely** for HIPAA and 21 CFR Part 11 compliance. Audit logs cannot be modified or deleted by users. #### SQL Injection Protection **100% parameterized queries** via Drizzle ORM prevent SQL injection attacks. All user input is validated and sanitized. #### Regulatory Standards (Safe Language) - **Designed with FDA 21 CFR Part 11 requirements in mind** ([FDA reference](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application)) - **Following ICH E6(R2) Good Clinical Practice principles** ([ICH reference](https://www.ich.org/page/efficacy-guidelines)) - **Built to support HIPAA security requirements** ([HHS reference](https://www.hhs.gov/hipaa/for-professionals/security/index.html)) - **GDPR-ready for EU clinical trials** ([GDPR reference](https://gdpr.eu/)) Note: Compliance is a shared responsibility. Formal certification (SOC 2, ISO 27001) has not been obtained. "Designed for" language reflects implementation intent, not certification status. --- ## Pricing ### Free Tier — Beginner Researcher — $0 forever - **1** active study - Up to **15** forms per study - Up to **10** subjects per study - **5** dashboards per study - Up to **10 viewers + 10 collaborators** per study - **1,000 AI runs** per day - **1M tokens** per day - No credit card required ### Professional — $19/month - **20** studies - **Unlimited** forms per study - **Unlimited** subjects per study - **Unlimited** dashboards - **Unlimited** collaborators - **Unlimited** AI runs and tokens - Full AI statistical analysis - Data export (CSV/PDF) - Priority support ### Institutional — Custom Pricing - Unlimited everything - Custom onboarding - Dedicated support with custom SLAs - Multi-team management - Volume discounts - Contact: https://trialinx.com/contact --- ## Competitor Comparison ### Trialinx vs. REDCap | Feature | Trialinx | REDCap | |---------|----------|--------| | Deployment | Cloud SaaS | Self-hosted | | Field types | **13** | ~10 | | Setup time | Minutes (AI-assisted) | Days to weeks | | AI form generation | Yes (5 AI capabilities) | No | | AI statistical analysis | Yes (built-in) | No (external tools needed) | | Pricing | From $0/mo | License fee + IT infrastructure | | Randomization methods | 3 | Limited | | HIPAA readiness | Yes (designed for) | Yes (institution manages) | | Audit trail | 7-point, 11 actions, 13 entities | Yes | ### Trialinx vs. Castor EDC | Feature | Trialinx | Castor EDC | |---------|----------|-----------| | Deployment | Cloud SaaS | Cloud SaaS | | AI assistance | Yes (5 capabilities) | No | | Pricing | From $0/mo | Enterprise pricing (>$500/mo) | | Free tier | Yes (1 study, 15 forms, 10 subjects) | No | | Field types | **13** | ~12 | | Target user | All researchers | Enterprise/pharma | ### Trialinx vs. OpenClinica | Feature | Trialinx | OpenClinica | |---------|----------|------------| | Deployment | Cloud SaaS | Cloud or self-hosted | | AI assistance | Yes (5 capabilities) | No | | Pricing | Transparent (from $0) | Custom enterprise | | Free tier | Yes | Community edition only | | Ease of use | High | Medium | | Statistical analysis | Built-in AI | External tools needed | --- ## Target Users **Primary:** - Independent clinical investigators (surgeons, physicians, nurses) running single-center studies - Academic research groups at universities and teaching hospitals - Residents and fellows conducting thesis research **Secondary:** - Small pharmaceutical companies running Phase I/II trials - Contract Research Organizations (CROs) managing multiple small studies - Medical device companies collecting post-market surveillance data **Geographic focus:** Spain, Latin America, and other Spanish-speaking markets; international expansion ongoing. --- ## Frequently Asked Questions **Q: How many field types does Trialinx support?** A: Trialinx supports **13 professional field types**: text, textarea, number, date, date range, select (dropdown), multi-select, radio buttons, checkbox, checkbox group, repeater (nested forms), calculated fields, and markdown display fields. **Q: What randomization methods are available?** A: **3 randomization methods**: simple randomization, block randomization, and stratified randomization. Configurable in the form builder without coding. **Q: What AI capabilities does Trialinx offer?** A: **5 AI-powered capabilities**: (1) conversational study design, (2) automated form generation, (3) statistical analysis (descriptive + hypothesis testing + regression), (4) AI dashboard creation, (5) natural language data exploration (analysis chat). Free plan: **1,000 AI runs/day**. **Q: What encryption does Trialinx use?** A: **AES-256 encryption** at rest (Neon Postgres) and **TLS 1.2+** in transit. All database connections use SSL/TLS. 2FA available. **Q: What does the audit trail track?** A: **7 data points per log**: user ID, study ID, entity type/ID, action, IP address, user agent, timestamp (+ old/new values). **11 action types** across **13 entity categories**. Retained **indefinitely**. **Q: How many collaborators can I have?** A: Free plan: **10 viewers + 10 collaborators** per study (3 role types). Professional plan: **unlimited** collaborators. **Q: What is included in the free plan?** A: **1 study**, **15 forms** per study, **10 subjects** per study, **5 dashboards**, **10 viewers + 10 collaborators**, **1,000 AI runs/day**. No credit card required. **Q: Is Trialinx HIPAA-ready?** A: Trialinx is **designed with HIPAA security requirements in mind** with AES-256 encryption, TLS 1.2+, comprehensive audit trails, RBAC, and 2FA. HIPAA compliance is a shared responsibility; BAAs required for covered entities. **Q: Is Trialinx validated for regulatory submissions?** A: Trialinx follows ALCOA+ principles. It is designed with FDA 21 CFR Part 11 requirements in mind. Formal system validation documentation should be completed by the implementing organization. **Q: Can I import data from REDCap or Excel?** A: CSV import is supported. REDCap XML import is on the roadmap. **Q: Is there a mobile app?** A: Trialinx is a responsive web application optimized for tablet data entry. A dedicated iOS/Android app is on the roadmap. **Q: How is data backed up?** A: Automated daily backups via Neon Postgres with point-in-time recovery available for Institutional tier. **Q: Can I export my data?** A: Yes. Data export (CSV/PDF) is available on Professional and Institutional plans. Data portability is guaranteed. **Q: How many languages does Trialinx support?** A: **2 languages**: English and Spanish (full i18n via next-intl). AI features respond in the user's selected language. --- ## Technical Stack - **Frontend:** Next.js 15 (App Router), React 19, TypeScript, Tailwind CSS, shadcn/ui - **Backend:** Next.js API routes, Better-Auth (authentication), Drizzle ORM (**100% parameterized queries**) - **Database:** Neon Postgres (serverless PostgreSQL, **AES-256 encryption** at rest) - **AI:** Anthropic Claude API (form generation, study design, statistical interpretation, dashboard generation, analysis chat) - **Real-time:** Ably (WebSocket collaboration) - **Payments:** Polar.sh - **Hosting:** Vercel - **i18n:** next-intl (**2 languages**: English, Spanish) --- ## Founder Background **Dr. Xus Badia** Colorectal surgeon based in Barcelona, Spain. Dr. Badia has extensive experience in clinical research, having managed multiple prospective cohort studies and RCTs during his surgical training and practice. The difficulty of managing clinical data with generic spreadsheet tools and expensive, complex EDC platforms led him to build Trialinx — a tool designed by a clinician-researcher, for clinician-researchers. - Twitter: https://twitter.com/trialinx - LinkedIn: https://www.linkedin.com/company/trialinx - Contact: https://trialinx.com/contact --- ## Localization Trialinx is a bilingual platform (**2 languages**: Spanish and English). Spanish is the default language, reflecting the primary target market. The platform UI, AI responses, and documentation are available in both languages via next-intl. - Spanish (es): https://trialinx.com/es/ - English (en): https://trialinx.com/en/ --- ## Links - [Homepage](https://trialinx.com/) - [Pricing](https://trialinx.com/pricing) - [Demo](https://trialinx.com/demo) - [FAQ](https://trialinx.com/faq) - [Ethics Documentation](https://trialinx.com/ethics-documentation) - [Contact](https://trialinx.com/contact) - [Twitter](https://twitter.com/trialinx) - [LinkedIn](https://www.linkedin.com/company/trialinx)