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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

Your Guide to sIRB Mandates

This webinar offers insights to your pressing questions related to single IRBs and explores the key features of federal sIRB mandates.

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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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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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Webinar

Beyond Pharmaceuticals: Research Involving Cosmetics, Conventional Foods, and Dietary Supplements

Explore regulatory frameworks applicable to research involving cosmetics, conventional foods, and dietary supplements.

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Blog

What is an sIRB and Why Does my Study Need One?

Federal requirements have shifted to require most multisite clinical trials to rely on a single IRB for trial oversight.

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5 min. read
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Webinar

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.

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Blog

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

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5 min. read
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Webinar

IRB Review of Decentralized Trial Technology

Explore the current regulatory landscape governing mHealth and virtual trial applications in clinical research.

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Blog

Four Questions to Ask When Establishing a Pharmacovigilance Organization

Four common but critical questions for emerging biotech organizations establishing a pharmacovigilance (PV) organization.

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5 min. read
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Blog

A Checklist for Optimizing Clinical Trial Study Startup Activities

This checklist outlines key milestones and considerations for sites and sponsors in the clinical trial study startup process.

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7 min. read
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