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Clinical Trial Management Software Services for Scalable Global Trials

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Enterprises & Startups

airmed
healthquest
speclipse
st-michaels
triple-ring
ecarevalut
Oculo
medical
acheolis

Why Legacy Clinical Trial Management Software Tools are Failing Modern Research

Every delayed clinical trial can cost anywhere from $600,000 to $8 million, and that’s not just a financial hit. Behind those numbers are patients waiting for treatments, providers caught up in broken workflows, and sponsors who are trying to make critical decisions. The stakes are high, and legacy CTMS tools are struggling to keep up.
Today’s trials demand more than just software; they need AI-driven insight and interoperable platforms that can actually adapt to their workflow. Unlike off-the-shelf solutions, our clinical trial management system software is specifically built to meet your needs. It connects your systems, surfacing real-time data, and giving your teams the flexibility to move with full confidence in every decision.

Custom Services in Our Clinical Trial Data Management Software

Study & Site Management

  • Real-time tracking of site activation and submissions
  • Tailored workflows that match your SOPs
  • Secure eTMF access through seamless API integrations

Participant Management

  • Linked with EDC, ePRO, and eConsent for smooth decentralized trial execution
  • 21 CFR Part 11-compliant audit trails and user-based access
  • Alerts for missed visits, SAEs, or status changes in real-time

Clinical Trial Financial Management

  • Automate site payments and track contract milestones
  • Multi-currency support for global studies
  • Plug-and-play integrations with NetSuite, SAP, and QuickBooks

Regulatory & Compliance Oversight

  • Manage submissions and version-controlled docs in one place
  • FDA 21 CFR Part 11, ICH-GCP, and HIPAA compliant
  • Built-in eSignatures, timestamped actions, and role-based access

Real-Time Reporting & Dashboards

  • Custom dashboards to monitor enrollment, deviations, and timelines
  • BI tools like Power BI and Tableau are fully integrated
  • Export-ready data formats for accessibility and easy usage

Integration Hub (API-First Architecture)

  • Connect EDC, eConsent, EMR/EHR, wearable devices, labs, and billing systems
  • Sync protocol details, demographics, billing grids, and more
  • RESTful APIs with CDISC ODM, HL7, and FHIR integration ensure secure, real-time data exchange

Investigator & Staff Portal

  • Dashboards, training logs, and task tracking for PIs and CRCs
  • Role-based access with automated reminders and alerts
  • Reduce protocol deviations with centralized oversight

Workflow & Document Automation

  • Drag-and-drop automation for alerts, approvals, and versioning
  • Document locking, expiration tracking, and rollback tools
  • Built-in eSignatures via DocuSign or Adobe Sign

Salient Features of Our Clinical Trial Management Software

AI-Driven Trial Oversight

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AI-Driven Trial Oversight

Predict enrollment trends, site performance, and protocol deviations using built-in AI models. It helps optimize trial execution with intelligent, data-backed insights.

Custom Workflow & Operations Engine

Configure task flows for monitoring enrollment, deviations, timelines, and document approvals. They are aligned with SOPs using drag-and-drop automation and real-time alerts.

Reduced Administrative Burden

Our ERP solutions enhance decision-making, resource allocation, and patient care delivery with healthcare data analytics services that leverage advanced analytics, artificial intelligence (AI) predictive insights, and automated workflows.

Protocol & Regulatory Management

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Protocol & Regulatory Management

Keep IRB approvals, version-controlled submissions, and document lifecycles organized with a clear 21 CFR Part 11 audit trail, making it easier to stay compliant.

Real-Time Reporting & Dashboard

Track key metrics with easy-to-use interactive dashboards. These connect smoothly with Power BI, Tableau, and HL7/FHIR data outputs for streamlined insights.

Clinical Supply & Inventory Control

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Clinical Supply & Inventory Control

Forecast IP needs with AI models, automate depot-to-site shipments, and maintain chain of custody through temperature logs and barcode scanning in clinical trial supply management software.

Participant-Centric Data Integration

Link EDC, ePRO, and eConsent for unified participant tracking in decentralized or hybrid trials. Ensure compliance and continuity across touchpoints.
See Features in Action

What You Gain with Our Clinical Trial Management Software Services

Global Regulatory Compliance

Ensure full compliance with HIPAA, GDPR, ICH-GCP, and FDA 21 CFR Part 11 using our AI-audited clinical trial data management software workflows.

Enterprise-Grade Security

Our clinical trial management system software is ISO 27001 certified with AI-driven access control, field-level encryption, and user-based permissions.

Lower Operational Costs

AI streamlines protocol tracking, subject engagement, and site workflows, reducing resource waste across your clinical trial financial management software stack.

Maximize Data Value

Our automated process unifies EDC, eConsent, and lab feeds, ensuring faster go-to-market via connected clinical trial management software ecosystems.

Optimized Clinical Supply Chain

Our clinical trial supply management software uses AI to predict IP needs, automate resupply, and track global shipments with full traceability.

Start Streamlining Your Trials

Simplified System Connections with Custom Clinical Trial Management Software

EMR/EHR Integration
Patient Demographics Interface
Protocol Billing Grid Integration
General Ledger Systems (ERP) Integration

EMR/EHR Integration

  • Sync protocol and subject data using HL7 RPE and FHIR standards
  • Automatically flag research participants through Epic integration and other EMR systems to streamline research coordination

Patient Demographics Interface

  • Auto-import demographic fields (DOB, ID, contact) from EMR to CTMS to improve speed and data consistency
  • Reduces staff workload and enhances accuracy in decentralized environments

Protocol Billing Grid Integration

  • Transfer billing designations to EMR for automated charge routing, medical insurance integration, and compliance
  • Smooth communication between the study and financial teams

General Ledger Systems (ERP) Integration

  • Reconcile CTMS-initiated invoices with healthcare ERP systems like Microsoft Dynamics 365 and NetSuite.
  • Align research and finance teams with a single source of truth in your clinical trial financial management software

eConsent & EDC Integration

Why Choose Folio3 for Clinical Trial Management Software Services

Healthtech Expertise
  • Backed by two decades of experience in digital health, we bring deep domain knowledge to every clinical trial management system software we develop.
  • We accelerate clinical trial timelines with AI-driven workflows for data capture, monitoring, financial management, and supply chain management in one intelligent platform.
  • We don’t offer a one-size-fits-all solution. Our clinical trial software services are fully tailored to your protocols, SOPs, and integration needs.
  • With an API-first foundation and support for HL7, FHIR, and CDISC ODM, we ensure smooth data flow across your systems.

Testimonials

Folio3 Digital Health Testimonial

Team Folio3 brought my dream app to reality, they explained every step to our non technical team professionally. wireframe and design processes were outstanding  & they built stunning and perfectly integrated application. I think both patients and clinic will be significantly benefited.

Folio3 Digital Health Testimonial
Folio3 Digital Health Testimonial

Working with the folio3 team has been a great experience. Your dedication, creativity, and adaptability in overcoming challenges for the Moodology app project are truly commendable.

Folio3 Digital Health Testimonial

I appreciate your remarkable work during the  recent Laboratory service phase. Your determination, analytical thinking, and continuous efforts were crucial in overcoming challenges and achieving success. I appreciate your help as we collaborate to create fantastic items.

Kudos to your team for outstanding work in the discovery phase! Your team understood our business and workflows by asking the right questions and extracting the most useful information. Your team's ownership and results-oriented approach are commendable.

Our Tech Stack

Python

Vue.js

FAST API

Django

.Net core

Nest.js

Node JS

Swift

Angular

Flutter

React

Ruby On Rails

TensorFlow

Scikit Learn

PyTorch

Google BigQuery

Apache Spark

Power BI

Azure Cognitive

OpenAI API

Amazon SageMaker

Apache Superset

Tableau

Hadoop HDFS

HL7 V2

FHIR

Smart on FHIR

Epic App Orchard

Docker

Jenkins

Terraform

Github Actions

Kubernetes

GitLab CI/CD

AWS

Microsoft Azure

Google Cloud

How We Deliver Seamless Clinical Trial Management Software Solutions

01.

Planning & Needs Assessment

We evaluate your study workflows, tech stack, and compliance goals to create a roadmap tailored for your organization.

02.

Interoperable Framework Design

Our experts plan integrations with EDC, EMR, eConsent, and ERP using HL7, FHIR, and RESTful APIs.

03.

Tailored Solution Engineering

Each module, from site management to financials and supply chain, is custom-built to match your clinical operations.

04.

QA & Compliance Checks

We validate your solution against regulatory standards such as HIPAA, 21 CFR Part 11, and GCP, ensuring full audit trails and strengthened security.

05.

Launch & Continuous Support

Once deployed, your clinical trial management software is backed by training, documentation, and ongoing support from our experts.

Frequently Asked Questions

What is clinical trial management software, and how does it benefit sponsors and CROs?
Clinical trial management software helps streamline the planning, execution, and monitoring of trials. It improves data visibility, site coordination, and compliance while cutting operational overhead for sponsors and CROs.
Our clinical trial management software is highly customizable and is built to align with your unique workflows, study phases, and SOPs. We also offer a clinical trial financial management software module to handle contracts, budgets, and automated site payments.
Yes. Our software supports HL7, FHIR, and API-based integration with EDC, EMR, and clinical trial supply management software to ensure seamless logistics, inventory tracking, data consistency, and reduce manual effort.
Yes. Our clinical trial management software is fully compliant with FDA 21 CFR Part 11, HIPAA, ICH-GCP, and GDPR. The clinical trial management system software features audit trails, e-signatures, and secure access controls tailored to every role.
Yes. Real-time dashboards and configurable KPIs are built into our clinical trial management software. Combined with our clinical trial data management software capabilities, we enable better forecasting, monitoring, and sponsor reporting.

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