Research Compliance
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.
The IND Journey Phase I – Navigating Success
Explore strategies for advancing investigational new drug (IND) submissions and a comprehensive guide through Phase I of the IND journey.
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.
Reuniting and Reconnecting at the 2022 Onsemble Conference
The 2022 Onsemble Conference provided an opportunity for attendees to reconnect in person and collaborate to move research forward.
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.
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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