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Webinar

Inspection Readiness: Before. During. After

Upcoming: October 13

This webinar will cover successful strategies for a proactive approach to FDA inspections before, during, and after.

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Blog

How the IND 30-day Hold Impacts Clinical Trial Activities

Find out what research activities can and cannot be conducted during the Investigational New Drug (IND) 30-day hold period.

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6 min. read
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Webinar

A Guide for Successful Cell and Gene Therapy Research

Upcoming: November 1

Understand the unique regulatory, clinical, and manufacturing requirements for cell and gene therapy research.

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Webinar

Growth Mode: Developing a Fit-for-Purpose QMS Model

Upcoming: October 6

Learn successful strategies for a stepwise implementation of a clinical QMS, tailored to companies in growth mode.

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White Paper

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.

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Blog

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.

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5 min. read
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Webinar

Oncology Innovations and Other Trending Topics from IRB Experts

Upcoming: September 29

August 24, 2022

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Blog

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.

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4 min. read
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Webinar

Tips for Accelerating Your Medical Device through the Product Lifecycle

Explore the latest strategies to accelerate your medical device throughout the product development lifecycle.

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E-Book

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.

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Blog

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.

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4 min. read
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Blog

Regulatory Considerations for Pharmaceutical Product Lifecycle Management

New FDA guidance (ICH q12) applies to pharmaceutical drug substances and products requiring a marketing authorization.

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4 min. read
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