IRB Services for Sponsors and CROs
Regardless of your project’s scope, therapeutic niche, or number of investigators, Advarra will support your studies with the right people, processes, and technology to help you advance clinical research: safer, smarter, faster™.
Advarra has been an excellent partner to PRA as we work to streamline the study startup process, improve transparency, and maintain the highest standards of human subject protection.
Jen Watford
Global Study Startup, PRA Health Sciences
Global CRO Drives Study Startup Efficiency by Converting Local IRB Sites to Central IRB Review
Optimizing Research Performance and Enabling Compliant, Safe, and Transparent Trials
Rely on outstanding service, real-time reporting, and consistent reviews
A central point of contact who knows you and your studies
Clear, coordinated communications
One study startup process for all sites
Web-based technologies available anytime, anywhere
Meet Critical Study Milestones with Rapid Turnaround Times
Advarra provides prompt, accurate, and thorough reviews. We can work with you to meet demanding timelines.
business days from submission to review
New protocol and initial informed consent for multisite studies (full board review)
business days from submission to review
New protocols and initial informed consent (minimal risk review)
business days from submission to review
New site for a multisite study
Please note: Turnaround time is dependent upon complete and accurate submission of study documentation. Any follow up requiring a response may extend this turnaround time.
Expert Oversight
Ensure Expert Oversight for All Types of Research
Leveraging deep regulatory expertise and broad experience across all major therapeutic areas and research phases, including specialized review services for oncology research, Advarra helps you navigate the changing regulatory requirements, ensuring appropriate participant protections.
In addition to supporting pharmaceutical and biopharmaceutical product studies, Advarra has reviewed all device study categories. Our IRB review experience includes implantable and portable devices, diagnostic tools, mobile medical devices, human factors testing, and HUD/HDE studies. Our experts are also adept at decentralized trial modalities and early phase research.
Scalable Services
Simplify Startup 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.
Study Feasibility
Study Feasibility and Site Selection Support
Advarra offers SiteIQ, the tool helping sponsors and CROs accelerate study startup and gain unparalleled visibility into site performance. More than a list of sites, SiteIQ provides detailed site performance metrics synthesized from actual completed studies.
Study Startup Efficiencies
Our early engagement services help you start studies faster and enroll more sites to meet critical milestones.
- The greatest institutional reach of any IRB: Advarra has working relationships with over 3,500 institutional sites, more than any other central IRB. 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, or craft a compliant ICF for the trial.
- Site identification and feasibility support: Augment existing site databases and increase study resources to identify high-performing sites with Advarra’s SiteIQ service. More than just a list of sites, SiteIQ simplifies study startup and offers 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.
- Efficient and effective site training: engage and prepare investigators and site staff with engaging, study-specific training via the Longboat Platform
- Draft review and advisory opinion: Increase the likelihood of a smooth, efficient review with your formal study submission. This robust review of your draft protocol 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 Advarra’s CIRBI Platform. No need to search through your emails — CIRBI manages IRB communications.
- Securely exchange documents: Advarra’s Longboat Platform centralizes the exchange of documents between your study team and your study sites, monitor status of documents in transit, and ensure documents and amendments are always up-to-date.
