CTMS and eTMF

End-to-end study management

Clinical trial management system

Manage every aspect of your research studies from protocol design through to close-out. Trialflare CTMS brings together your sites, teams, and participants in a single platform built for modern study delivery.

  • Multi-site coordination
  • Live enrolment tracking
  • Participant screening, pre-screening and scheduling
  • Automatic randomisation and eligible participant allocation
  • Visit management and reminders
  • Role-based access and team management
  • Real-time analytics and reporting
  • Automatic alerts for safety and safeguarding
Scorch AI

Supercharge your trials management

Everything you need to manage participants, sites, and study operations from start to finish.

Participant onboarding and retention

Screening, eligibility checks, eConsent, and enrolment in one seamless flow. Automated reminders, scheduling, and multi-channel communications keep participants engaged throughout the study.

Monitoring, visits and reporting

Live dashboards for enrolment, compliance, and site performance. Schedule and track monitoring visits, manage queries, and generate audit-ready reports without leaving the platform.

Filing, site and personnel management

Configure sites, assign roles, and manage team permissions across your entire study. The built-in eTMF keeps all trial documentation centralised, version-controlled, and inspection-ready, so nothing falls through the cracks at audit.

Seriously secure

Enterprise-grade encryption, UK/EU data residency, and full compliance with GDPR, HIPAA, and 21 CFR Part 11. Cyber Essentials Plus certified.

Site performance dashboards

Track enrolment rates, query volumes, and protocol deviations across every site in real time. Identify underperforming sites early and take action before timelines slip.

Automated visit scheduling

Define visit windows and let Trialflare handle the scheduling. Participants and coordinators receive automated reminders so visits stay on track.

Inventory and supply tracking

Monitor investigational product stock levels across sites and maintain a complete chain-of-custody record for every item.

Complete audit trails

Every action is logged with timestamps, user identity, and IP address. Inspection-ready from the moment your study goes live.

Scorch AI

Built for trust, designed for oversight

Every layer of Trialflare CTMS is designed to protect your data, streamline your operations, and keep your studies inspection-ready.

GDPR & HIPAA

Full regulatory compliance with data stored in UK/EU centres.

21 CFR Part 11

Electronic signatures and validated systems for FDA submissions.

ICH GCP

Workflows structured around Good Clinical Practice guidelines.

Cyber Essentials Plus

Independently verified cyber security controls and infrastructure.

Scorch AI

Intelligent study coordination

Study coordination

Trialflare uses AI to take the manual work out of study management. From automated scheduling and smart task assignment to enrolment forecasting, your team spends less time on admin and more time on research.

Automated task assignment

Tasks are automatically created and assigned based on study milestones, visit schedules, and team roles. Nothing falls through the cracks.

Smart enrolment forecasting

AI-driven predictions based on your screening pipeline, site capacity, and historical data help you spot enrolment risks before they become delays.

Kanban workflow boards

Visualise participant journeys, task progress, and site activities on intuitive drag-and-drop boards. Keep your entire team aligned at a glance.

Trialflare eTMF document management Trialflare manual queries Trialflare automatic queries Trialflare personnel management Trialflare site management Trialflare packs Trialflare task management
eTMF

Built-in electronic trial master file for centralised document management and audit readiness.

Manual queries

Create manual triggers for data input queries to flag issues for review by coordinators.

Automatic queries

Let the system create query triggers automatically based on data validation rules and thresholds.

Personnel management

Manage study team roles, permissions, and responsibilities across all sites.

Site management

Coordinate across multiple sites with centralised oversight and performance tracking.

Pack management

Organise and distribute study materials, supplies, and resources to sites efficiently.

Task management

Kanban boards, task assignment, and workflow tracking to keep your study team on track.

Automated scheduling

Visit schedules and appointment reminders are managed within Trialflare. Coordinators and participants always have the latest schedule at hand.

Email notifications

Automated email alerts for upcoming visits, overdue tasks, enrolment milestones, and protocol deviations keep your team informed without manual chasing.

Sponsor reporting portals

Give sponsors and monitors secure, read-only access to live study dashboards. No more compiling status reports or sending spreadsheet updates by email.

Scorch AI

Connected study operations

Optimised Comms

Keep every part of your study connected. Trialflare integrates with the tools your team already uses, so information flows automatically and nothing gets lost between systems.

Scorch AI

Compliant and secure by default

GDPR, HIPAA, 21 CFR Part 11, ICH GCP, and Cyber Essentials Plus certified. UK/EU data centres, 2FA, role-based access, and full audit trails on every action.

GDPR HIPAA FDA 21 CFR Part 11 ICH GCP Cyber Essentials Plus

Learn more about

Scorch AI

How CTMS works

From initial configuration to final report, Trialflare CTMS guides your study through every stage. Four steps from setup to close-out.

Faster setup

Configure your study in days, not weeks. Templates, role presets, and guided workflows get you live faster.

Better oversight

Real-time dashboards give sponsors, PIs, and coordinators instant visibility into study progress and site performance.

Reduced cost

Automating scheduling, task management, and reporting cuts administrative overhead and frees your team to focus on research.

Faster insights

Live analytics and automated reporting mean you always know where your study stands, without waiting for manual data pulls.

01

Configure your study

Set up your protocol, define visit schedules, configure roles and permissions, and add your sites. Trialflare's guided setup walks you through every step.

02

Recruit and enrol

Screen participants against eligibility criteria, manage consent workflows, and track enrolment progress across all sites in real time.

03

Manage visits and data

Coordinate visit schedules, capture data, track protocol deviations, and manage queries. Automated reminders keep participants and coordinators on track.

04

Monitor, report and close

Access real-time analytics, generate regulatory reports, and manage study close-out with complete audit trails and data export.

Who we work with

Ready to streamline your study management?

Get started with Trialflare CTMS today.

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