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.
Advarra provides prompt, accurate, and thorough review, and we can work with you to meet demanding timelines.
Delivering Insight Without Inconvenience
Simplified Communication to Support Faster Submission and Review
With Advarra’s One-Touch Collaboration, your research team benefits from an outstanding service experience, a single point of contact, and consistent reviews from our integrated, single IRB. It is our goal to proactively facilitate your study experience and deliver unmatched support. Benefits include:
- One central point of contact who knows you and your study(ies)
- One stream of clear, coordinated communications
- One study startup process for all sites, whether an institution or an independent research site
- One set of forms, processes, and document templates for clear document management
Unlike other IRBs, Advarra offers a truly single IRB review and delivers white-glove service to our clients. We also guarantee an outstanding, streamlined process from submission to final documentation.
Typically, Advarra can perform a full board review of a new protocol and informed consent for a multisite trial within 4 business days. Expedited review of a new minimal risk protocol and informed consent can be completed within 2 business days or even less depending on your need. Advarra also provides rush review services to help you meet demanding timelines. As your partner, Advarra is committed to getting your trial started on time and helping you reach critical study milestones quickly.
Leading Intelligence for Every Research Program
In addition to offering expert guidance across all major therapeutic areas, Advarra provides 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 to drive ethical research.
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 IRB 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
Advarra recognizes the unique needs associated with large clinical trials: high-volume site reviews, milestone achievements, priority sites, fast turnaround, steady communication with the IRB, and more. 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, and our collaborative approach to project management helps coordinators stay engaged and informed throughout the submission and review process. Our study startup services, which combine personalized service, submission assistance, and comprehensive reporting, can help your large, high-priority study reach every milestone.
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. Our regulatory team can help determine the appropriate classifications for your product.
Study Startup Efficiencies
Our early engagement services help customers start studies faster and enroll more sites to meet critical milestones.
- The Greatest Institutional Reach of Any IRB: Advarra has working relationships with over 3,100 institutional sites, more than any other central IRB. Simplify study management and speed startup by engaging Advarra as the IRB of record for all of your sites. Request our institutions list to see if your preferred sites already work with us (chances are, they do).
- Regulatory Consultations/Protocol Writing: Advarra Consulting can help design or write your study protocol.
- Site Identification and Feasibility Support: Augment existing site databases and increase study resources to identify high-performing sites with Advarra’s Performance Data Quicklist (PDQ) service. More than just a list of sites, PDQ helps sponsors and CROs simplify study startup and gain unparalleled visibility into site performance.
- Rapid Site Activation: Onboard sites in less than one day and shrink total IRB review and approval time with Advarra’s IRB-Ready® approach.
- Draft Review and Advisory Opinion: Submit a draft protocol for full board review and increase the likelihood of a smooth, efficient review with your formal study submission. This pre-review can address questions about study design, participant protections, and regulatory requirements.
- Real-Time Study Information and Reports: Stay up to date on the IRB review process with real-time data from the Advarra CIRBI® Platform. No need to search through your emails — IRB communications are managed through your CIRBI account.
Technology Enabled Solutions for Streamlined Processes
The 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 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
Get a Quote
As part of our continued effort to help clients achieve reduced fulfillment time, Advarra offers a complimentary quote request feature to help you quickly and accurately budget for your next study.
Try out this new, no-obligation feature today: Get a quick quote
After submitting your study details, we will contact you within 1 business day.
Start a Study
If you are from a sponsor or a CRO and are managing a multisite study, 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 therapeutic area, the phase of the study, how many sites you expect will submit to Advarra, and how you would like us to handle certain tasks (safety reporting, site submissions, translations, advertisements, etc.). The more we know from the start, the better prepared we will be for your study’s particular needs. The CIRBI SmartForm adapts to your answers, only showing you questions that are relevant to your submission.
What to Expect
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.
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.