Above all, you can trust Advarra to provide high-integrity review and feedback regardless of project size, scope, or complexity.
Experienced Project Managers
Advarra’s coordinators help you streamline tasks and reach a full understanding of compliance recommendations.
With web-based technologies that are available anytime, anywhere, you can log in to view projects and plan ahead.
Providing Compliance Without Compromise
Flexible Solutions Tailored for Each Institution
Advarra works with each institution to ensure that institutional policies and other local concerns are appropriately addressed, including development of institution-specific informed consent text and collaboration with local research office requirements. An experienced point of contact is always available to assist with inquiries regarding studies under Advarra oversight.
Leading Intelligence for Every Research Program
Advarra offers extensive expertise across all major therapeutic areas and continues to pioneer highly specialized review services for areas such as oncology. Across all major and niche therapeutic areas, throughout every stage of research, Advarra provides expert-led IRB services.
Speed and Agility for Phase I and Beyond
Collaboration between the primary study contact and the primary IRB reviewer helps streamline the transfer of study materials to the IRB. Pre-review processes can identify potential issues or discrepancies in a submission, giving you time to rectify matters before IRB review. Advarra also offers Performance Data Quicklist (PDQ), the tool that helps sponsors and CROs accelerate study startup and gain unparalleled visibility into site performance.
Advarra understands Phase I research is unique, and we have developed a dedicated set of services to support Phase I trials. With the timelines in Phase I/healthy, a study can start within days of an initial IRB application.
Advarra’s IRB members and staff are familiar with the range of Phase II studies. Our regulatory team can provide assistance in preparing these medium-sized, fast-paced studies for submission, and our operations teams provide guidance in the management and oversight of the ethics review process.
Advarra excels in the management and oversight of Phase III studies. Our early engagement services reduce the time needed to design, organize, and launch a study. Our fast timelines for review and document delivery keep you on schedule, and our knowledgeable staff is there to help when you need it.
Advarra supports a wide variety of Phase IV trials, including registries, observational studies, and online research. Phase IV studies frequently are minimal risk without interventions and can qualify for expedited review.
Broad Institutional Support Experience
Advarra can provide support for academic medical centers (AMCs), health systems, colleges, universities, hospital systems, community hospitals, nursing facilities, and other centers that may or may not have local IRBs. Advarra can also serve as an institution’s IRB where there is not a local IRB with jurisdiction or where the local IRB defers jurisdiction in writing to Advarra.
Public funds account for an important segment of research in Canada and in the United States and lead to crucial discoveries. Advarra pivots smoothly between private and public funding; we apply the same processes and resources to each. Our AAHRPP-compliant IRBs comply with the United States’ Common Rule and Canada’s Tri-Council Policy Statement. We can oversee federally funded studies as a local IRB for a single investigator or as a single IRB for multisite studies. We include grant reviews in each submission to the IRB.
Single IRB (sIRB)
If your institution receives NIH funding for multisite research, then you’ll need a single IRB (sIRB) of record. Set your institution up for success by designating Advarra as your sIRB of record. Benefit from our existing processes, procedures, and resources, including budget planning support for grant applications.
Building your own sIRB or serving as a coordinating center for the first time? Empower your institution to thrive in the new sIRB reality. Let Advarra Consulting assess your sIRB program, processes, and documents to help avoid the stress of noncompliance.
Investigator-initiated studies have some additional considerations before review. Your study may be investigator-initiated if you are the author of the protocol, if you have initiated the research yourself, or if you are assuming all regulatory responsibilities for the research. Contact us if you have any questions.
Community-based research comprises a range of activities in health, education, social, and behavioral science as well as other disciplines designed to systematically gather important information about various aspects of the human condition. Most of these research projects employ qualitative research methodologies, or a mix of quantitative and qualitative methodologies, and often include special circumstances. Community-based research functions work best by engaging and collaborating with communities and their citizens, beginning with defining the research need through collaboration to completion of the research and communication of the results to the various stakeholders.
Advarra has broad experience in reviewing community-based research conducted in virtually every region of the globe; this experience is as diverse as the patient needs assessments, health determinants, and outcomes in various communities and strata of society. These include studies of substance abuse, domestic violence, problem gambling, human factors, and educational intervention innovation, among many others. These projects are often publicly funded or funded by the communities themselves with limited governmental or NGO support.
Going Beyond the Basics
Advarra also offers a variety of customizable training options for investigators and research support staff. Moreover, Advarra’s utmost focus is on review quality. An expert team works with each institution to make sure human subject protection issues are considered appropriately and that proper levels of subject matter expertise are dedicated to study reviews.
Technology Enabled Solutions for Streamlined Processes
Center for IRB Intelligence (CIRBI) Platform
The Online Platform Setting the Gold Standard in Review Quality, Submission Turnaround Time and Document Accessibility
Spend less time on paperwork. Increase visibility into your research with a robust, Part 11 compliant electronic system. Expand and support your research programs in new ways. With Advarra’s expert-led solutions, IRB-Ready® approach, and powerful IRB platform, your investigative team can conduct research with greater efficiency and security.
The Advarra CIRBI Platform, a paperless, cloud-based IRB submission and review system, will enable you to create shared workspaces with customizable settings for relevant stakeholders in your institution, supporting efficiencies across your entire research enterprise.
Throughout the Process:
Dedicated Project Manager, Real-Time Tracking, Direct Communication and Guidance, Data Retention for Fast Follow-Up
Start a Study
Depending on the nature of your submission, you may be considered an investigative site working with a sponsor or a CRO on a multisite study, or you may be submitting a single site study. We consider your research a single site study if you are an investigator working directly with Advarra on a protocol level as well as on a site level, whether that protocol is yours or a sponsor’s.
For either scenario, log in to the Advarra CIRBI Platform to begin the submission process. Our SmartForms collect the information we need to set up your study and ensure we have all the documentation in hand for IRB review, including the size and location of your site, your consenting practices, whether any conflicts of interest exist at the site, and whether the IRB should be aware of any local concerns or regulations. The more we know from the start, the better prepared we’ll be for your site’s particular needs. The CIRBI SmartForm adapts to your answers, only showing you questions that are relevant to your submission.
What to Expect
Single site studies: Once we receive your submission, our team will review it and contact you with any follow-up questions. When the submission is complete, we’ll assign the study to a client services coordinator (who will remain your primary contact throughout the study) and schedule the study for the next available IRB meeting.
We review protocols every day of the workweek, and the IRB will review your protocol within 4 days of receiving a complete submission — we can review qualifying minimal risk studies much more quickly. During those 4 days, your client services coordinator may contact you about any issues; this can include follow-up questions from our IRB members or operational teams.
Within 1-2 days of the IRB meeting, your client services coordinator will let you know of the results and provide any follow-up information. You then will have a chance to respond to any questions and to review any ICF changes that we suggest. Once an IRB approval is final, our standard is to post approval documents within 1-2 business days. Sites can be reviewed while the protocol is under review; just bear in mind that site approvals will be held until the protocol has been approved.
Investigative sites participating in a sponsored multisite study: We review site submissions every day of the workweek. Within a few hours of a review, our team can update you on the results and provide any follow-up information.
Once IRB approval is final, we will post the approval letter and an approved version of the study’s ICF(s) to the Advarra CIRBI Platform. Most of our site approvals post within 2 days.
What to Check
The Advarra CIRBI Platform is your one-stop resource for review status information and approval documentation. Follow-up activities are conducted in CIRBI, so no need to hunt down emails — all correspondence is available in a centralized dashboard.
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