Research Compliance
5 Questions to Ask Your Sponsor for DCT Implementation
Sponsors are uncertain about how to design a DCT to ensure efficient performance delivery, learn how to set your organization up for success.
Regulatory Considerations for Pharmaceutical Product Lifecycle Management
New FDA guidance (ICH q12) applies to pharmaceutical drug substances and products requiring a marketing authorization.
CBD Research: A Dive into the Regulations of Cannabis Research
With cannabis usage becoming more popular, there’s an uptick in research surrounding its therapeutic effects.
Bridging the Gap: A Standardized Approach to Clinical Trial Document Management
Representatives from the Advarra Site-Sponsor Consortium will discuss a standards-based integration and automation of research technology.
Beyond Pharmaceuticals: Research Involving Cosmetics, Conventional Foods, and Dietary Supplements
Explore regulatory frameworks applicable to research involving cosmetics, conventional foods, and dietary supplements.
Regulatory Pathways: When to Follow a 505(b)(2) or an ANDA
Critical insights and key considerations for selecting the best regulatory pathway to ensure success for new drug application submissions.
Short Form Consents and the Unexpected Non-English Speaking Participant
What happens when an unexpected non-English speaking participant shows up, and there isn’t enough time to obtain a translated study consent?
Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents
Global & FDA regulations dictate how researchers organize & store trial documents. Learn the basics of eTMF & eISF clinical research tools
Developing an Enterprise Roadmap to Post Authorization Safety Studies
Learn how an organization achieved organization-wide compliance and managed its post-authorization safety studies.
Common Pitfalls in Preparing an IND Application
While the IND application process may be straightforward to some, we explore the most common pitfalls as sponsors prepare for submission.
IRB Review of Decentralized Trial Technology
Explore the current regulatory landscape governing mHealth and virtual trial applications in clinical research.
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