Reporting Requirements
Navigating the FDA Emergency Use Filing Process
Partnering with Advarra, one nonprofit successfully obtained an Emergency Use Authorization from the FDA within five weeks.
Considerations for Transitioning from Paper to eSource
Explore the benefits of switching from paper to eSource, tips for implementation, and how to maintain compliance.
James Riddle and Willie Muehlhausen Discuss Digital Technology and Virtual Data Collection in Clinical Research
In this episode, we discuss the growth of decentralized clinical trial technology and how IRBs evolved to account for technology advancements.
For FDA Inspection Readiness, Accountability is Key
An Advarra expert provides insight in this Q&A session on the FDA inspection readiness process, including how to improve current workflows.
Q&A: FDA Updates: BIMO – What Sponsors Need to Know
Advarra experts Joan Versaggi and Leslie Paul answer questions from the webinar- FDA Updates: BIMO – What Sponsors Need to Know.
Maintaining Data & Reporting Integrity with Mobile Health
Understand how to properly handle and evaluate incoming data gathered using mobile health (mHealth) apps and technologies.
SiteIQ
SiteIQ leverages site performance and patient availability insights to gain unparalleled visibility into site performance
Encouraging Site Centricity and Collaboration at Onsemble
At the 2021 Fall Onsemble Conference, attendees learned about putting site centricity and collaboration at the helm of research operations.
The Importance of Keeping DSMBs Independent
By ensuring the DSMB is truly independent from study conduct, sponsors make trial data more trustworthy and enhance public confidence.
US Medical Device Regulation 101
Speed the review process by understanding how medical devices are classified & what the IRB must review to approve device research.
IRB Review of Phase I Research: Balancing Ethics and Efficiency
Find out how to address Phase I research challenges to enable efficient IRB review and timely study startup.
Understanding eSource, ePRO, and EDC
eSource, ePRO, and EDC are integral to efficient clinical research. This blog explores how they work together and their differences.
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