Reporting Requirements
Beginner’s Guide to Pre-IND Meetings
This blog provides a beginner’s overview of what the pre-IND meeting is and how to prepare for one.
Establishing and Operating a DSMB: Tips for Clinical Trial Success
This white paper shares what a data safety monitoring board's (DSMB's) role is in clinical research and how it works.
What do I do About Incidental Findings in Research?
Each incidental finding has an impact on how research professionals handle the result and whether it should be shared with participants.
What Goes into a Charter for DSMB or Endpoint Adjudication?
This blog outlines the key elements of a DMC/EAC charter document, explaining its importance in conducting safe and compliant research.
When Do I Need an EAC?
View this infographic to learn when do you need an endpoint adjudication committee (EAC) and what types of studies an EAC reviews.
Planning Organizational Design for Clinical Development Organizations (CDOs)
The white paper outlines key elements for clinical development organizations’ organizational redesign to improve productivity.
Cosmetic Research and IRB Review
Download the info sheet to learn about IRB review of cosmetics research, including applicable regulations and the IRB’s role.
5 Considerations for Evaluating an eIRB System
Provide guidance for research requests to the IRB, identify the appropriate regulations, and simplify the process from submission to review.
The Powerful Potential of Open Collaboration
Explore key takeaways from the Consortium’s first in-person meeting at the Onsemble Conference and welcome new members.
Advarra Releases Expanded Secure Document Exchange Capabilities as Part of Longboat Platform Release, Connecting Sites and Sponsors
Centralize the secure exchange of regulated documents between research stakeholders, streamlining study startup.
Clinical Endpoint Adjudication Committees: Not Just for “Endpoints”
This blog outlines critical events where EACs are used to look at more than just “endpoints” in clinical research.
Canadian Medical Device Regulation 101
Canadian medical device regulations can be tricky to navigate. View this infographic to learn the REB review process for medical devices.
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