Advarra® combines a dedicated project management team with powerful online tools to simplify collaboration.
Deep Therapeutic Expertise
Advarra is a long-standing leader across all major therapeutic areas and continues to set the standard in new and expanding fields.
With web-based technologies that are available anytime, anywhere, you can log in to view projects and plan ahead.
Providing Review Without Roadblocks
Advarra gives you faster access to information, easier record management, and secure communication tools. This helps you provide greater value to research sponsors and study participants. Advarra’s fully validated submission and review platform, CIRBI, also gives you the power to manage your project anytime, anywhere. With the CIRBI Platform, version-controlled document tracking and access are simple. By outfitting your team with always-accessible tools, you can keep data security and regulatory compliance in check all while driving more action with less bureaucracy.
Leading Intelligence for Every Research Program
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.
Flexibility for Large and Multinational Megatrials
Even as trials progress through Phase IV, Advarra can scale review and compliance services and tap an outstanding network of experts for particularly large, unique, or complex projects. Advarra’s processes and technology ensure transparency while simplifying system/site onboarding, while a collaborative approach to project management helps coordinators stay engaged and informed throughout the submission and review process.
By applying deep expertise across all major therapeutic areas, Advarra continues to pioneer highly specialized review services for areas such as oncology. Across all major and niche therapeutic areas, throughout every phase of research, Advarra provides expert-led IRB services.
Support for Pharmaceutical, Medical Device, and Diagnostic Products
Leveraging deep regulatory expertise and broad therapeutic experience, Advarra will help you navigate the changing regulatory requirements and ensure appropriate human subject protections regardless of the product being studied. Beyond supporting pharmaceutical and biopharmaceutical product studies, Advarra has reviewed all categories of device studies, with IRB review experience including implantable and portable devices, diagnostic tools, mobile medical devices, human factors testing, and HUD/HDE studies.
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.
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
Shorten Your Site Activation Timeline
Traditional site activation can take up to two-thirds of your enrollment cycle, which often forces studies to be delayed. Advarra’s unique IRB-Ready® approach and proprietary CIRBI Platform can cut your site activation time in half.
Improve Your Communication
Advarra delivers on the promise of time-saving technologies with the CIRBI Platform, the fully electronic platform that provides secure, direct communication of critical information and a real-time view of the review process and status, keeping you connected and facilitating your work on the go.
Make Informed Decisions
The CIRBI Platform will empower you to track your research sites’ approvals in real time. On-demand reporting via CIRBI will also help you identify issues and make decisions that keep your trial moving.
eConsent technologies can improve subject understanding and help research participants make informed decisions about participation in your research study. In many cases, eConsent solutions may also streamline the consenting process and reduce operational complexity. Advarra can support the development of your eConsent with your internal team as well as third-party vendors. Advarra is fully eConsent-capable and has the experience to help you navigate the electronic informed consent review process. We understand the technology’s potential, its limitations, and how it fits within the regulatory requirements.
- Experienced IRB: Our IRB has years of experience with eConsent and its unique requirements and IRB considerations.
- Streamlined Review: Our industry-leading process for reviewing eConsent is easy and in sync with oversight agency recommendations, including the FDA Guidance: Use of Electronic Informed Consent, Questions and Answers.
- Technological Expertise: IRB members include leading experts in developing eConsent-enabled trials. They understand the process and the technology, and they serve to ensure the ethical review thoroughly covers technological elements. Plus, IRB members see an eConsent document just as a participant would — whether by PC, tablet, or other device.
- Platform-Agnostic Approach: Advarra can review electronic consents developed by any industry vendor in any format. We do not limit ourselves to working with a single vendor or operating system.
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.