Newsletter | August 15, 2024

08.15.24 -- Mistakes To Avoid During An FDA Inspection

REGULATORY & COMPLIANCE

Mistakes To Avoid During An Inspection: Insights From A Former FDA Investigator

Vincent Cafiso has heard — and seen — it all when it comes to what NOT to do during an FDA inspection. Here he gives some good advice on who you should have present in the room during an inspection and how you should interact with the investigator.

How The Australian Advantage Maximizes Benefits For US Biotechs

The "Australian Advantage" approach offers US biotech firms numerous benefits, including a cash rebate of almost 50%, faster timelines, no IND requirement, and globally accepted data.

The Future Of Regulatory Operations

The pathway to enhancing reliability, compliance, and efficiency across lifecycle management will require embracing technology and process improvement if organizations want to achieve their goals.

Moving In Unison: Proprietary Scheduling Platform

Join us for an exclusive discussion that uncovers the science behind our efficient management of key sponsor deliverables and critical milestones, driving our projects to success.

OUTSOURCING MODELS

Storyboarding: The Secret Weapon Of GCP Quality Assurance

Discover how storyboards in GCP quality assurance can serve as a framework for crafting clear, consistent messaging that resonates across inspection teams.

Enhancing Value In High-Performing Research And Development Teams

Strategic partnerships are characterized by highly advanced therapeutics and increasingly segmented patient populations. Here, we explore the necessity of multidisciplinary collaboration.

Your Partner In Psychiatry Research

Our extensive network of specialized Healthcare-First psychiatry research sites is dedicated to advancing psychiatric care through cutting-edge clinical studies.

10 Questions For Choosing A Mobile Research Nursing Provider

A growing number of sponsors and CROs recognize the benefits of conducting a hybrid or remote clinical trial. Decide which one is right for your next trial by asking these 10 questions first.

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