Research Operations
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.
Developing Models to Scale Your Training Program
This webinar covers strategies for adapting your training program using in-person, live virtual, and virtual/asynchronous approaches.
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.
Clinical Trial Superheroes
Download this eBook to learn about the individuals who dedicate their talents to give patients an opportunity for healthier and longer lives.
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.
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.
mRNA Clinical Trials: Key Regulatory Considerations
Responses to the most frequently asked questions regarding mRNA technology and clinical trial regulatory requirements.
Expedite Study Startup: Four Strategies to Optimize Site Activation
Learn how organizations can expedite study startup by streamlining site selection, training, ethics review, and site initiation.
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