IRB Management System

Make Research Ethics Review
Faster, Transparent & Compliant

Harasoft's IRB system has stably served healthcare institutions for over 10 years. It has served the TMU Joint IRB since 2015, during which TMU's three affiliated hospitals have maintained AAHRPP international accreditation. From application to approval, fully digitized management dramatically improves your IRB operational efficiency.

10+
Years Running
24x7 Uninterrupted
500+
Workflow Nodes
184 Node Types
21
System Roles
Precise Permissions
8
Case Categories
One-stop Management

Trusted by leading medical centers, university hospitals, and research-active universities in Taiwan

Designed for multi-site joint IRBs, Taiwan c-IRB (joint ethics review) cases, and AAHRPP-aligned operations.

Why Harasoft IRB

Are You Facing These Challenges?

Harasoft IRB system is designed to solve research ethics review pain points

Long Review Cycles

Manual tracking is time-consuming, cases get stuck, PIs frequently inquire about status, increasing administrative burden

Automated workflows & smart alerts
Document Chaos

Email exchanges, attachments scattered everywhere, can't find latest versions, causing review delays or errors

Complete version control
Accreditation Prep

AAHRPP accreditation and Joint Commission of Taiwan (JCT) IRB inspections require massive manual data compilation, overtime to prepare reports

AAHRPP case-statistics report export
Lack of Transparency

PIs can't check case status in real-time, admin staff exhausted answering progress inquiries

Real-time self-service status
Core Benefits

Why Choose Harasoft IRB?

International Standards

Designed around ICH-GCP, with a built-in AAHRPP case-statistics report that can be filtered and exported to support accreditation record-keeping.

Flexible Workflow Engine

Quickly adapt to SOP changes, old and new workflows can run in parallel, ensuring in-progress cases aren't affected by system updates.

10+ Years Proven Track Record

Taking Taipei Medical University (1 university, 3 hospitals) as example, system running 24x7 uninterrupted for over 10 years, handling growing case volumes.

Three Core Values

Efficiency

Automated case assignment, online review voting, digital meeting management - dramatically shorten review cycles.

Transparency

Real-time status queries, single source of truth, complete history tracking - eliminate information asymmetry.

Compliance

Version control, digital signatures, COI management, complete audit trails - support research ethics compliance.

Covering All 8
IRB Review Workflows

From new applications to site visits, the main IRB case types are managed in one place. 500+ workflow nodes (184 node types) help the office handle a wide range of review scenarios.

Request Full Workflow Guide
1
New Application
Full/Expedited/Exempt
2
Amendment
Change Tracking
3
Continuing Review
Renewal Management
4
Final Report
Complete Archiving
5
Withdrawal / Suspension / Termination
Status-based Handling
6
NC/UAP
Non-compliance/UAP
7
SAE Reporting
Timeline Management
8
Site Visit
Audit & CAPA
Extended Modules

Additional Capabilities

Beyond core IRB functions, we offer integrated solutions for clinical trials and research management

Clinical Trial Finance
  • Budget planning & settlement
  • Invoice & payment tracking
  • Transparent finance dashboard
  • Multi-site financial integration
Biobank Management
  • Specimen storage & requests
  • eConsent integration
  • Specimen tracking & audit
  • Supports human research record-keeping
University Admin
  • Industry-academia cooperation & personnel secondment
  • Patent, technology transfer & licensing
  • Meeting management
  • Official-document system integration
System Integration
  • SSO single sign-on
  • Document system integration
  • Third-party API integration
  • E-signature service

Ready to Upgrade Your IRB Review Process?

Schedule a free demo to see how Harasoft IRB can help your organization
improve efficiency and support compliance and accreditation record-keeping.

Usually responds within 1-2 business days