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:
Reduces administrative burden
Provides reminders and alerts
Provides status of submission review
Notifies of approval or next steps
Scaleability and flexibility
Expert support team
IRB Committee Members
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
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.
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.
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.
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.
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.
Manage your forms, projects, reviews, and submissions all from one view. See upcoming expirations, start new projects and view pertinent announcements.
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.
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!
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
Support for calculating information based on other form data to support budget preparation, enrollment tracking, approval vs actual comparisons and more.
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
Stop repetitive clicking for every single action! Email stakeholders, assign reviewers, update data fields, revise expirations, and generally follow your SOPs automatically.
Not everyone can see everything, support for internal/external restrictions as well as restricting data to specific named individuals
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
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.
Apply digital signature to PDFs to indicate authenticity and prevent post-approval alteration
Full support for sending, and receiving, emails with outside sources, such as the research team, auditors, legal and oversight, and more
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
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
Automatic emails to keep all stakeholders informed of submission progress
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.
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
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
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.
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
Compare uploaded Word and PDF documents to show changes between versions
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
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
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