Research Compliance
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.
Let’s Get Ethical
Advarra's IRB Chairs Luke Gelinas and Amanda Higley discuss hot topics in clinical research, including cannabis studies and data ownership.
A Look at the Processes Behind Clinical Endpoint and Event Adjudication
Take a closer look at how and why we leverage proprietary, custom, and intelligent technology in our EAC program
Top-Tier University Stays Compliant with Advarra’s HRPP Assessment
A top -tier university worked with Advarra’s Institutional Research Center of Excellence to assess HRPP compliance with federal regulations
Why Device, Diagnostic, and Digital Therapeutic Research Needs Endpoint Adjudication
This blog outlines when a device clinical trial sponsor should engage an EAC or CEC to provide specific medical expertise & safety oversight.
Understanding the EU Clinical Trials Regulations Updates
The new European Union regulations have significant implications for sponsors submitting trials in the EU.
Improving Regulatory Workflows in Study Startup
This newsletter outlines the Consortium's efforts to improve regulatory workflows in study startups.
Addressing Research Technology Challenges to Gain Sponsor Buy-in
Encouraging site-owned technology platforms enables site staff to produce their best work, increasing the likelihood of a study’s success.
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