Consulting
Growth Mode: Developing a Fit-for-Purpose QMS Model
Learn successful strategies for a stepwise implementation of a clinical QMS, tailored to companies in growth mode.
Rare and Orphan Diseases: Choosing a Path to Regulatory Approval and Market Success
Explore the regulatory challenges and pathway guidance for sponsors bringing innovative rare and orphan therapies to market.
Regulatory, Clinical, and Quality Considerations for Device Research
Medical device manufacturers are facing increasingly complex pathways to successfully bring their innovative ideas to the market.
Oncology Innovations and Other Trending Topics from IRB Experts
Join colleagues from NCI-designated cancer centers to discuss the unique ways oncology has pioneered clinical trial advancements.
An Evolving Regulatory Environment for Rare and Orphan Diseases
By 1983, only 38 orphan drugs received FDA approval. Since then, the FDA has significantly changed its approach to rare and orphan diseases.
Tips for Accelerating Your Medical Device through the Product Lifecycle
Explore the latest strategies to accelerate your medical device throughout the product development lifecycle.
Advarra Trend Report: Current State of Trial Opportunity and Selection
Insights into the site selection process and the information sites provide as part of site feasibility questionnaire completion.
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.
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.
Q&A: The IND Journey Phase I – Navigating Success
Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success.
The Revolving Door of Research: The Resourceful Way to Run Trials
Examine the current state of industry resources, resourcing implications, and the way we can now think of work: remote, hybrid, or on-site.
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