IRB compliance can be overwhelming and time-consuming, but you can simplify it at every stage and reduce your risk with intelligent workflow automation.

Simplify Protocol Management

Create and manage IRB protocols with dynamic forms, pre-populated data, and real-time approval status visibility.

Simplify Submissions

Make the submission process smoother and faster, reducing errors and eliminating bottlenecks that slow down approval timelines.

Accelerate Approvals

Speed up the approval process by automating routing and notifications, ensuring your protocols get reviewed and approved quickly without unnecessary delays.

Guide Through Compliance

Easily navigate the strict regulatory requirements with built-in guidance, helping investigators and coordinators stay on track and ensuring full compliance at every step.

IRB Module That Adapts To Your Industry’s Needs

Scalable, industry-specific solutions to ensure smooth and compliant human research processes.
01
Simplify Protocol Management
Provide a single portal for protocol submission, modifications, renewals, and adverse event reporting, reducing complexity and improving efficiency for faculty and students.
02
Automate Workflow Routing
Streamline the approval process with automated routing, ensuring protocols are reviewed by the right people at the right time without manual delays.
03
Track Approval Status in Real-Time
Give investigators and administrators access to dashboards that provide real-time visibility into the approval status, ensuring timely progress on research.
04
Maintain Accreditation Compliance
Ensure compliance with AAHRPP and federal oversight by maintaining a built-in audit trail that tracks every protocol action, providing transparency and readiness for accreditation reviews.
01
Simplify Protocol Submissions
Provide an easy-to-use platform for submitting and renewing protocols, making the process simple and efficient for smaller teams handling both research and compliance.
02
Ensure Timely Renewals
Get automated reminders when your protocols are about to expire, ensuring renewals are handled on time.
03
Strengthen Your Institution’s Credibility
Built-in compliance documentation supports your credibility with funders, offering them transparency and assurance that all protocols are handled properly.
04
Reduce Administrative Burden
Streamline both research and compliance workflows with an integrated system, allowing staff to focus on research while ensuring compliance tasks are efficiently managed.
01
Streamline IRB Submissions
Simplify IRB submission and approval workflows, reducing the administrative burden on small teams and accelerating the timeline for early clinical trials.
02
Centralize Compliance Tracking
Consolidate compliance reporting across both internal teams and CRO partners, ensuring all stakeholders are aligned and reducing the risk of oversight.
03
Prevent IND Delays
Set automated alerts for renewals and reporting deadlines, ensuring timely compliance and avoiding delays in IND filings.
04
Ensure Audit-Ready Documentation
Maintain comprehensive, audit-ready documentation that meets FDA inspection requirements, ensuring full transparency and regulatory preparedness.
01
Standardize Compliance Across Sites
Unify IRB compliance workflows across all sites and subsidiaries to ensure a consistent approach to protocol approvals, regardless of location or scale.
02
Monitor Compliance in Real-Time
Leverage centralized dashboards to give compliance leaders real-time access to protocol approval status, enabling quicker decisions and reducing delays.
03
Ensure Regulatory Compliance
Track audit trails aligned with FDA, EMA, and ICH requirements to maintain transparency and safeguard against regulatory risks across global trials.
04
Integrate with Clinical Operations
Align protocol approvals with trial activations by seamlessly integrating with clinical operations systems, speeding up execution and improving efficiency.
01
Streamline Protocol Approvals
Automate protocol tracking to eliminate manual compliance logs and streamline the approval process, reducing legal and technical handoff delays.
02
Reduce Compliance Risks
Centralize oversight by integrating various systems and providing a unified platform to track amendments, renewals, and protocol deviations, ensuring compliance without silos.
03
Enhance Audit Accuracy
Maintain comprehensive audit trails that document every step of protocol submissions
and reviews, ensuring complete, accessible records and mitigating the risk of fragmented audit data.
04
Track Protocol Deviations
Automatically flag protocol deviations and generate alerts, ensuring quick response to issues and preventing compliance gaps.
01
Streamline Trial Activation
Automate protocol submission and review workflows to reduce turnaround times, accelerating trial activations and minimizing delays caused by IRB backlogs.
02
Improve Tracking and Transparency
Provide real-time tracking for IRB approvals, renewals, and adverse event reports, ensuring that all stakeholders are informed and can act promptly.
03
Ensure Patient Safety Oversight
Maintain clear, comprehensive documentation that demonstrates patient safety protections, ensuring compliance and minimizing risks during clinical trials.
04
Enhance Investigator Satisfaction
Reduce investigator frustration by automating routine tasks, providing faster protocol reviews, and offering clear visibility into approval processes.

Streamline Human Compliance At Every Stage & Reduce Risks

Smart Forms

Accelerate submissions with dynamic AI-powered forms that flag compliance issues and reduce revision cycles.

Version Control

Track changes effortlessly with automatic versioning of protocols, ensuring the latest version is always available.

Renewals & Amendments

Manage updates easily by tracking protocol renewals, amendments, and adverse events in real-time.

Centralized Access

Ensure transparency by giving all stakeholders one version of the application, eliminating data silos and human error.

Automated Workflow

Automate protocol approval routing, document review chains, and automated task assignments for compliance checks.

Meeting Agendas

Create agendas automatically, saving time and ensuring no details are missed in review meetings.

Audit Trail

Maintain compliance with a complete, accessible history of forms, comments, and meeting records for full visibility.

Meeting Minutes

Record meetings automatically, with complete documentation of discussions and decisions.

Custom Reports

Generate insights with both standard and ad-hoc reports to track protocol status and performance.

Electronic Submissions

Simplify submission with fully electronic protocols, eliminating paperwork and manual tracking.

Seamless Integration

Connect systems easily with integrations that sync your protocol data across platforms.

Connect Your IRB Module To Everything That Matters

Easily connect the IRB module with other compliance systems such as IBC, RSC, SCRO, CS, CSC. Additionally, you can also connect with your existing systems, such as patient health records, HR, or finance, to access the real-time data you need. With our platform's open architecture, you can seamlessly plug into your HR and finance systems without burdening your IT team.

Our Research
Compliance Modules

IACUC (Institutional Animal Care & Use Committee)

Facilitate the review and monitoring of all animal research protocols, ensuring full compliance with IACUC regulations for both USDA and non-USDA species.

IBC (Institutional Biosafety Committee)

Protect personnel, human subjects, and society from biohazards by efficiently reviewing research protocols involving carcinogens, infectious agents, and allergens.

SCRO (Stem Cell Research Oversight)

Streamline the approval and documentation process for stem cell research, ensuring consistent oversight and compliance with SCRO guidelines.

CSC (Chemical Safety Committee)

Simplify CSC compliance by automating protocol submissions, ensuring safer use of hazardous chemicals and stronger oversight in research environments.

CS (Controlled Substances)

Simplify CS compliance by guiding research teams through complex regulations governing the use of drugs and controlled substances.

RSC (Radiation Safety Committee)

Ensure safe and compliant use of radioactive materials in research through structured RSC protocol review and enforcement.

PAM (Post-Approval Monitoring)

Facilitate regular inspections of approved protocols and swiftly implement corrective actions to ensure continuous compliance with established safety and research standards.

Events

Explore our upcoming events and see what’s next in compliance and digital solutions.

Latest Insights

Discover fresh perspectives from global leaders with our collection of blogs on research compliance, administration, animal care, and more.

Frequently Asked Questions

1.  How easy is it to complete the protocol application with the IRB module?

It’s much easier. The IRB module offers smart forms that streamlines the compliance process and can be adjusted as per your requirements. It allows you to reference relevant details from other systems, such as IACUC and IBC, eliminating the need for repetitive manual entry. Plus, it flags potential compliance issues early, helping you stay on track and save time.

2. Can the IRB module integrate with other systems we already use?

Yes, the IRB module integrates smoothly with the systems you already rely on. Whether it’s your clinical trial management system (CTMS), electronic health records (EHR), laboratory management systems (LIMS), or document management platforms like SharePoint or cloud storage solutions, everything connects effortlessly. This smooth integration capability of our IRB module enables data flow across departments, reducing the need for manual data entry, minimizing errors, and providing real-time, accurate information to support faster, more efficient decision-making.

3. How does the IRB module help reduce compliance risks?

The module provides real-time alerts for any potential compliance issues, ensuring all submissions and amendments meet regulatory standards before they are submitted. AI-driven workflows guide users through every step, flagging any discrepancies early in the process.

4. Can I track protocol amendments and renewals with the IRB module?

Yes, the module tracks protocol amendments and renewals by keeping a centralized record of all changes, ensuring compliance with ongoing research requirements and preventing missed deadlines.

5. How does the IRB module help speed up the approval process?

The IRB module helps speed up the approval process by verifying that all required components of the protocol submission have been completed before submission, ensuring all relevant details are in place. It keeps things moving with real-time notifications and document tracking, reducing the time spent waiting for approvals and making the whole process more transparent.

6. How does the IRB module handle protocol versioning?

The IRB module takes care of protocol versioning automatically. Every time there’s an amendment or update, the system keeps track and ensures that only the latest version is being used. This way, you’re always working with the right, compliant version, without worrying about missing or outdated information.

7. What security measures are in place to protect sensitive data in the IRB module?

The IRB module uses top-tier security protocols, including data encryption, secure cloud storage, and role-based access controls, to ensure that sensitive research data remains protected throughout the submission and review process.

Discover What an Intelligent Integrated Research Compliance Platform Can Do For You

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