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
Typically, Advarra can perform a full board review of a new protocol and informed consent for a multisite trial within four business days. Expedited review of a new minimal risk protocol and informed consent can be completed within two 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.
New protocol and initial informed consent for multisite studies (full board review)
4 business days
New protocol and initial informed consent (minimal risk review)
1–2 business days
New site for a multisite study
1 business day
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 and neurology. 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.
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.
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.
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.
Throughout The Process:
Dedicated Project Manager, Real-Time Tracking, Direct Communication and Guidance, Data Retention for Fast Follow-Up