IRB Services for Private Research Sites and Site Networks
Manage regulatory requirements, simplify reporting, and streamline project communications with Advarra’s experts, processes, and technology.
Why Advarra
Streamlined Communication
Advarra combines a dedicated project management team with powerful online tools to simplify collaboration.
Real-Time Reporting
With web-based technologies that are available anytime, anywhere, easily log-in to view projects, gain visibility into the status and timelines of your reviews, and plan ahead accordingly.
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, including dedicated expertise for oncology research.
Responsive Service
Advarra’s dedicated team members spend more time focused on you because they’re supported by the transparency and efficiency of the IRB-Ready® approach and the Center for IRB Intelligence (CIRBI®), Advarra’s unique cloud-based submission and review platform.
Meridian Site Network Builds Robust Gene Therapy Research Program Leveraging Integrated IRB and IBC Services
Partnering with Advarra’s Institutional Biosafety Committee, Meridian Clinical Research established a program for conducting clinical trials with cutting edge, genetically engineered vaccines.
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Empowering Clinical Sites
Start Faster with Streamlined Submission and Review Support
- A central point of contact who knows you and your study(ies)
- Clear, coordinated communications
- One study startup process for all sites
- Web-based technologies that are available anytime, anywhere
Conduct More Trials
Stay in control while initiating new research studies with Advarra’s IRB-Ready® approach. Your team at Advarra will maintain a dialogue with you, supporting quicker recruitment and enrollment and reduced time from site activation to first patient/first visit.
Meet Critical Study Milestones with Rapid Turnaround Times
Advarra provides prompt, accurate, and thorough reviews, and we can work with you to meet demanding timelines.
- New protocol and initial informed consent for multisite studies (full board review): 4-5 business days
- New protocol and initial informed consent (minimal risk review): 1-2 business days
- New site for a multisite study: 1-2 business days
Please note: Turnaround time reflects timeline from receipt of submission to IRB review. Turnaround time is dependent upon complete and accurate submission of study documents. Any follow up requiring a response may extend this turnaround time.
Efficient Collaboration
Advarra gives you faster access to information, easier record management, and secure communication tools. With the fully validated Advarra CIRBI Platform, version-controlled document tracking and access are simple. 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 early phase research 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. We also offer dedicated, expert capabilities to meet the unique needs of early phase research.
Support for pharmaceutical, medical device, cell and gene therapy, and diagnostic products
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 research, 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
Advarra can help sponsor investigators meet the unique challenges and responsibilities of investigator-initiated studies. Your study may be investigator-initiated if you are the primary author of the protocol, if you have initiated the research yourself, or if you are assuming all regulatory responsibilities for the research (i.e, serving as both investigator and sponsor).
Technology-Enabled IRB Processes for Streamlined Reviews
Advarra’s industry-leading IRB utilizes experience and technology to ensure streamlined ethical review of your research. Enabled by our electronic IRB management platform, CIRBI, you’ll gain transparent access to real-time review statuses, efficient submissions with easier processes, and accelerated activation and review timelines.:
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Advarra can support the development of an eConsent process with your internal team as well as third-party vendors. Advarra’s IRB 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.
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Advarra Integrated Solutions
Your collaborative partner for advancing clinical research: safer, smarter, faster.
Gain comprehensive visibility into your research operations, increase your financial viability, enhance compliance across your enterprise, and enable strategic decision-making with our comprehensive portfolio of standards-based solutions.
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Increase your research productivity, maximize your investment, and experience breakthrough efficiencies with our technology-enabled and professional services.
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Join Advarra’s Gene Therapy Ready network to make sure your site is prepared to conduct cutting-edge research.
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Ready to make your researchprogramsafer, smarter,faster?
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