Optimizing a Clinical Development Program to Improve ROI
Clinical development proceeds in phases, and each phase contains a set of clinical trials. These trials, including their sample size
sponsors
IRB Review of Social Media Recruitment and Retention Programs
Social media can be a valuable tool for researchers to connect with and recruit potential clinical trial participants. However, US regulations
The Value of Early Engagement with Your IRB
It’s no secret that in clinical research, everything moves at a quick pace – and that doesn’t stop when working
Beginner’s Guide to IND Safety Reporting Under 21 CFR 312(c)
Read about IND safety reporting required under FDA 21 CFR 312.32(c), challenges faced in adhering to the regulation, and strategies to ensure compliance.
Study Activation: Top Four Takeaways from Research Sites
While enrolling subjects is arguably the most crucial aspect of clinical research operations, this cannot be done without activating a
How to Successfully Conduct Virtual Investigator Meetings
In a remote clinical research landscape, a successful virtual investigator meeting can ensure a more cost-effective and compliant clinical trial.
Cell & Gene Therapy vs Drug Research: What’s the Difference?
Cell and gene therapy’s popularity has grown exponentially in the past year. However, it’s important to understand how cell and gene therapy research is different from traditional drug development.
Addressing Barriers to DEI in Clinical Research
Breaking down barriers to participation in clinical research has long been a challenge, affecting every aspect of the industry. As
Making the Most of Site Training: Lessons from the Pandemic
The shift to virtual site training reveals innovative ways to maintain engagement and consistency, enhancing site readiness in remote settings.
The Power Of Patient Advocacy In Drug Development
Recently, we discussed the importance of connecting with advocacy groups in order to create more trial diversity. As a result
Q&A from Remote Monitoring: Study Compliance In A Changing World
In a recent webinar, Advarra experts Emily Eldh and Ben Shankle provided insights and information in Remote Monitoring: Study Compliance
Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation
Developing an investigational new drug (IND) application is a big milestone for organizations, especially small companies bringing their first drug