Accelerate Clinical Trials With Audit-Ready CTMS
TrialScale unifies study startup, real-time RBQM risk scoring, automated milestone payments, and investigative site workflows into an audit-ready operational platform designed for 21 CFR Part 11.
Engineered for Clinical Trial Velocity & Rigorous Compliance
Eliminate disconnected spreadsheets, delayed monitoring trip reports, and reconciliation bottlenecks. Everything your clinical trial team needs, unified.
Streamlined Study Startup (SSU)
Automate investigator site package dissemination, feasibility scoring, and local IRB/IEC tracking. Accelerate cycle time from site selection to First Patient In (FPI).
- Automated Greenlight Workflow & Checklist
- Dynamic Regulatory Binder Distribution
21 CFR Part 11 & Annex 11 E-Signatures
Strict non-repudiation with cryptographic dual-factor authentication, cryptographic SHA-256 audit trails, and automatic reason-for-change capturing on all field mutations.
- Immutable Time-stamped Audit Trails
- Electronic Signatures with Meaning & Manifestation
Real-Time RBQM & Key Risk Indicators (KRIs / QTLs)
Continuously calculates site-level Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) aligned with ICH E6(R2) standards for targeted centralized monitoring and safety trigger alerts.
- ICH E6(R2) & E6(R3) Modern Framework
- Centralized Statistical Anomaly Detection
Automated Milestone Financial Ledgers
Eliminate complex spreadsheet reconciliations. Trigger investigator grant payments automatically upon subject visit completion, monitoring sign-off, or milestone verification.
- Dynamic Holdback & Pass-Through Accounting
- Automated Invoice & Tax Export Integration
Interoperable Clinical Data Architecture
Designed for bi-directional data exchange with modern EDC, RTSM, and eTMF platforms via CDISC ODM-compatible data exports and structured REST APIs.
- Bi-directional Subject Status Sync
- Structured Data & Document Export
Continuous Verification & CSA Alignment
Built from day one with automated test coverage, regression testing, and traceable requirements documentation aligned with GAMP 5 Category 4 guidance.
- Computer Software Assurance (CSA) Aligned
- Continuous Verification Pipeline
Purpose-Built for Both Sides of the Trial
Sponsors require high-density risk analytics and multi-study oversight. Investigative site coordinators need frictionless simplicity with zero training burden.
Sponsor Clinical Trial Manager (CTM) Command Center
Global oversight: Protocol ONC-302 • 12 Countries • 48 Sites • 420 Subjects
Site Risk & Milestone Matrix
Sorted by Key Risk Indicators (KRIs)| Site | Institution | Enrollment | KRI Status | Trip Report | Status |
|---|---|---|---|---|---|
| SITE-101 | Memorial Sloan Kettering | 18 / 20 (90%) | 0.08 Low | Approved | Activated |
| SITE-104 | MD Anderson Cancer Ctr | 22 / 20 (110%) | 0.11 Low | Signed | Activated |
| SITE-112 | Charité Berlin | 12 / 15 (80%) | 0.42 Medium | Due in 2d | Review Req |
| SITE-128 | Univ. Tokyo Hospital | 5 / 15 (33%) | 0.78 High | Overdue | Targeted Audit |
Monitoring Visit Reports (MVRs)
Milestone Disbursements
Computer Software Assurance (CSA) & GAMP 5 Category 4 Alignment
Traditional CTMS implementations take months of manual validation overhead. TrialScale is architected to align with FDA CSA and GAMP 5 Category 4 risk-based approaches, providing structured verification frameworks for your QA team.
Requirements-to-test mapping maintained through automated testing and continuous integration.
Standardized test scripts and qualification procedures to accelerate your internal IQ/OQ validation.
Strict role-based access control, encrypted data at rest and in transit, and HIPAA BAA availability for PHI protection.
Cryptographic audit trails, non-repudiation electronic signatures, and password complexity controls.
Request the CSA & GAMP 5 Architecture & Compliance Whitepaper
A technical guide for QA and clinical ops leaders: risk-based testing methodologies, data integrity controls, and qualification strategy.
Whitepaper Requested
Thank you. Our team will share the latest architectural brief and qualification framework.
Interactive Clinical Trial ROI Estimator
Quantify timeline compression, monitoring cycle savings, and site payment reconciliation efficiency across your active protocol portfolio.
Projected Portfolio Impact
Predictable Clinical Operations Pricing
Transparent subscription tiers without punitive per-seat licensing penalties for site coordinators or investigators.
Study startup and site coordination for emerging biopharma running 1 or 2 active clinical protocols.
- Up to 2 Active Protocols (25 Sites/Study)
- Study Startup (SSU) & Greenlight Tracking
- Essential Document Binder & IRB/IEC Workflows
- Unlimited Site Investigator & Coordinator Seats
- 21 CFR Part 11 Audit Trail & E-Signatures
- Standard CSV & EDC Export
Full operational and financial automation for biopharma sponsors and mid-tier CROs managing multi-center studies.
- Up to 10 Active Protocols (Unlimited Sites)
- Automated Milestone Financial Ledgers
- Real-Time RBQM & Key Risk Indicators (KRIs / QTLs)
- Subject Visit Tracking & Disbursement Triggers
- REST API & CDISC ODM-Compatible Data Sync
- Enterprise SSO (SAML 2.0 / Okta / Azure AD)
Sovereign, dedicated infrastructure for high-volume sponsors and CROs with complex portfolio requirements.
- Unlimited Active Protocols & Global Sites
- Air-Gapped / Sovereign AWS VPC Deployment
- Tailored Data Lake & Legacy EDC Ingestion
- Custom Enterprise BAA & Tailored DPA
- Dedicated Clinical Solutions Architect & 24/7 SLA
- Vendor Audit Support & Qualification Reviews
Modern Clinical Infrastructure, Grounded in Real Trial Experience
TrialScale was founded on years of direct experience inside life sciences, pharma, and clinical trials. We lived the friction of study startup, protocol amendments, and fragmented spreadsheets—so we built the platform we always needed.
Built by Life Science & Clinical Operations Veterans
Domain NativeSoftware built by generalists fails clinical operations because it doesn’t understand the reality of site burden, regulatory inspections, or complex milestone contracts. We spent years in the trenches of clinical research—managing site activations, monitoring visits, and audit preparation. Every workflow in TrialScale reflects that real-world operational memory.
Tired of Legacy Monoliths
Existing CTMS platforms were architected over fifteen years ago. Having used them across trial phases, we saw how brittle integrations, slow release cycles, and punitive per-seat licenses hold back clinical teams.
Compliance Engineered In, Not Bolted On
We understand the scrutiny of GCP and regulatory inspections. TrialScale is engineered from day one to support FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 principles with cryptographic audit trails and automated verification.
Early-Stage Agility, Senior Domain Focus
As an early-stage company, we don't have bureaucratic layers. You partner directly with leadership that speaks clinical trials fluently to tailor workflows to your active protocols.
Our Early-Adopter Design Partner Program
Join a select cohort of biopharma sponsors and CROs working directly with our experienced clinical ops leadership to streamline protocol execution.
Schedule an Executive Platform Walkthrough
See TrialScale configured for your therapeutic area. In this 30-minute tailored session, a Clinical Solutions Architect will review:
Protocol Setup & SSU Configuration
How your active study protocols and site startup checklists map into automated workflows.
Real-Time RBQM & KRI Anomaly Engine
Live demonstration of Key Risk Indicators (KRIs / QTLs) and automated trip report workflows.
GAMP 5 & 21 CFR Part 11 Architecture
Review of system architecture, data integrity controls, and qualification strategy.
Request Qualified Demo & Trial Access
Complete the brief intake below and our clinical team will respond within 4 business hours.
Qualification Request Confirmed
Thank you. A Clinical Solutions Architect has received your study requirements and will reach out shortly.