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.
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.
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).