Skip to main content

OneAegis for IRB

OneAegis for IRB (formerly IRBManager) is a SaaS solution that supports full lifecycle management of IRB submissions from initial project ideas through reviews, meetings, ongoing submissions, and of course reporting.

Leveraging the OneAegis flexibility we bring best practices to the table while supporting the individual IRB differences, ensuring that your policies, state and federal regulatory requirements, and your institutional ethos is represented in your processes.

OneAegis benefits all participants in the IRB review process:

Researchers

Reduces administrative burden
Simplifies submissions
Quicker approvals
Provides reminders and alerts
Provides status of submission review
Notifies of approval or next steps

IRB Administration

Process efficiency
Process transparency
Quicker approvals
Robust reporting
Scaleability and flexibility
Expert support team

IRB Committee Members

Easier reviews
Standardized review process
Automated notifications and alerts

“OneAegis’ workflow tools and reporting have been imperative to the flow of our business processes.  The Research Administrators, College and Department Administrators, and Investigators have all benefited from the ease of being able to create and submit proposals and protocols in a timely manner.  Also, our vast suite of modules has enabled us to create data integrations between Grants, Compliance and COI records.”

IRB OPERATIONS DIRECTOR RESEARCH UNIVERSITY

Structured Flexibility

OneAegis provides the structure but also provides the flexibility. A scaleable solution that can handle the specific requirements of any organization’s IRB, whether it is in a Healthcare, Academic, Educational, Governmental or Commercial environment. OneAegis is unmatched when it comes to the flexibility.

Security & Compliance

Your data is housed in encrypted, secure locations in the US.  We meet the highest requirements for security and privacy with application-level security, server redundancy and continual monitoring.  We can support all the documentation and audit logs needed to manage regulatory and publications risks.

Process Automation

OneAegis has a powerful set of tools for automating workflows and streamlining the experience for all users – Administrators, Researchers, Board Members, etc. This includes powerful and flexible automated notifications, routing of forms and communications, report generation, etc.

Information Repository

Everything you need to meet regulatory requirements in one central repository for compliance, funding and study related documents and data.  OneAegis ensures that users are notified of continuing review requirements, training requirements and conflict of interest reminders.

Risk Management

OneAegis helps organization manage regulatory risk, including audits, and research publication risk. The benefits are clear: good performance sites get more studies and avoid negative press.

Reporting and Metrics

OneAegis is unmatched in reporting capabilities. In addition to a wide range of standard reports that can be modified with sorting and filtering, we offer a unique, slef-managed ad-hoc reporting tool. The platform can provide direct read-only access to the client’s full database to pull data for use in third-party reporting tools.

Platform Independence

The OneAegis solution can be accessed by users anytime, anywhere, and on any device. It is available 24/7/365 not only in the US, but globally. Our platforms has been accessed by users across 169 countries on 6 continents.

Expert Support Team

The OneAegis Support team is an impressive group of people with graduate degrees and certifications. You will find a team of former compliance admins, research coordinators, program directors, etc. who are ready to guide you through your set up and support your day to day operations.

OneAegis provides a wide range of features that can be customized to fit any IRB process.

 

Friendly Dashboards

Manage your forms, projects, reviews, and submissions all from one view. See upcoming expirations, start new projects and view pertinent announcements.

Document Generation

Upload your document templates and allow OneAegis to automatically populate merge fields and generate as either word documents or PDF. Use data from OneAegis fields, your own User Defined Fields or answers from forms.

Smart Forms

More than just asking your users questions; OneAegis xForms encompass the entire submission workflow, from creation of the form, through the entire review processes including revisions, communications with the researcher, board notifications and assignments and finally the approval documentation. And xForms are versioned so you can change them without impacting existing submissions!

Form Collaboration

Invite other research personnel to review or answer forms before submittal. Allow faculty advisors to review and comment on applications as they’re being developed in order to encourage the best first submission possible

Calculated Fields

Support for calculating information based on other form data to support budget preparation, enrollment tracking, approval vs actual comparisons and more.

CITI Integration

Integrate the CITI daily feed to notify research personnel when required trainings are due to expire and also inform form submitters of needed training for personnel ASAP instead of waiting for feedback from office personnel. You can choose to prohibit submissions containing personnel needing training.

Standard and Ad Hoc Reports

Full set of standard reports online and exportable as well as an ad hoc report writer where you can save and schedule reports

Workflow Automation

Stop repetitive clicking for every single action! Email stakeholders, assign reviewers, update data fields, revise expirations, and generally follow your SOPs automatically.

Field-Level Security

Not everyone can see everything, support for internal/external restrictions as well as restricting data to specific named individuals

Site Management

Track master list of places research occurs (buildings, hospitals, institutions) based on need. Maintain information about these sites including inspection dates, phone numbers, billing details, and more. Automate reviews of sites for quality and regulatory compliance

PDF Stamping

Apply PDF stamps to documents to indicate “approved” copies of a document. Stamps can contain data elements such as approval and expiration date, committee, PI, etc.

Digital Signing

Apply digital signature to PDFs to indicate authenticity and prevent post-approval alteration

Integrated Email

Full support for sending, and receiving, emails with outside sources, such as the research team, auditors, legal and oversight, and more

Initial Submissions

Starting at the very beginning users complete smart electronic forms to request reviews of new projects. These forms are specific to your institutional needs and can be changed, by you, at any time

Amendments

Users can submit amendments either by copying their previous submission (copy for amend) or completing a stand-alone amendment form depending on your needs

Continuing Review / Annual Check-in

Researchers submit smart forms for CR and annual check-in needs. Supported across all types of approvals including full board, expedited, and even exempt

AEs, Closures, Deviations, and more

Support any type of process or oversight need including adverse events, UPIRTSOs, study closures, etc.

Events and SOP Management

OneAegis reflects your standard operating procedures and ensures you follow them with documentation necessary for auditor review

Automated Agenda Build

One-click build of your agenda for upcoming meetings with flexibility to rearrange or remove items to reflect business priorities

Minutes, Attendance, Voting

Track your meeting including attendance, voting, and generating minutes documents

Notifications

Automatic emails to keep all stakeholders informed of submission progress

Online Reviews

Assign your reviewers (committee or otherwise) and have them complete their reviews through smart review forms with automated notification of assignment and completion

Project Home Page

Single page to view current status of a project including overview, contacts, approvals and expirations, notes, events, and more.

Flexible Roles

Out of the box support for “standard” roles like PI, Coordinator, Research Staff, etc. But also the freedom to define additional roles to meet business needs.

Role and Attribute Based Security (RBAC & ABAC)

Robust security model ensuring the right people see the right projects at the right time.

Single Sign On (SSO)

Integrate with institutional identity management solutions (AzureAD, Okta, Shibboleth, etc.) and stop having to manually provision and maintain user accounts.

Sponsor Submissions and Study Management

Sponsors and CROs are first-class users with access to their sponsored projects and visibility across performance sites

Change Tracking / Audit

Full history of all changes made, who made them, and when. Exactly what’s needed for 21CFR11 and other compliance requirements

Metrics

Track turn around time and other metrics at both a high-level and micro-detailed level depending on need. OneAegis also supports tracking times before and after an “acceptable” submission is received

User Defined Fields

Extensibility to save, report, and reuse information about a project that is unique to your organization. Including support for repeating data through user defined tables

Cross-Project Relationships

No project is an island, reflect relationships between your projects with ease. For example, link IRB approvals to grant submission, IBC projects to IACUC projects, Conflict Disclosure to research approval, etc.

Document Upload

Smart xForms are great, but sometimes just an upload is what’s needed. Upload any size documents from small PDFs to high-definition video files including a full version history

Document Comparison

Compare uploaded Word and PDF documents to show changes between versions

Multi-Committee

Support unlimited committees including both internal and external ones. Easily report on which committees have which projects

Note and Email Templates

Why write the same text over and over? Store frequently used notes and emails for easy reuse

Submission Reminders

OneAegis will automatically remind PIs that forms are awaiting their signature and reviewers of assignments awaiting completion. Also useful for any other stakeholder (legal, department chair, nursing, finance, etc.) whose feedback is required process an application

Expiration Reminders

OneAegis automatically sends reminder emails for upcoming expiration dates to help ensure renewal submissions are submitted on a timely basis

Third Party Reporting Tools

Extend our great reporting support with 3rd party reporting tools like Tableau, Power BI, SSRS, Crystal Reports, etc.

Multiple Project Types

Institutions can configure as many project types as needed to support their business needs (IRB, IACUC, IBC, Scientific Review, Drone Safety, etc…)  Each project type can have their own dashboards, administrators and security to limit access appropriately

APIs and Integrations

Integrate with other systems to keep the entire research enterprise moving in the same direction

Cloud Security, Compliance, and Performance

The people, processes, and technology to ensure the confidentiality, integrity, and availability of the data and processes you entrust to us

 

 

Send us a Message

Get in touch with us