Newsletter | June 26, 2025

06.26.25 -- 25 Tips To Prepare A Clinical Site For FDA Inspection

REGULATORY & COMPLIANCE

25 Tips To Prepare A Clinical Site For FDA Inspection

During the last year I have interviewed six former FDA investigators and a regulatory expert who has been involved with more than 250 inspections. From all those interviews, I’ve culled the following list of takeaways that I hope you will find useful when preparing for any type of regulatory inspection.

Navigating The Evolution Of EU HTA Regulation

The future of pharmaceutical access in Europe is being shaped by the new EU Health Technology Assessment (HTA) regulation. Discover insights from Pharma 2025 that shed light on this pivotal shift.

How The FDA Is Phasing Out Animal Testing Requirement

The FDA is embarking on a transformative initiative to phase out animal testing requirements.

Embrace Quality Risk Management To Build A Strong Quality Culture

Using QRM gives a company the ability to maintain compliance while also identifying product issues that could be harmful to the consumers, some being susceptible patients.

Strategies For Research Institutions In An Evolving Era Of Oncology

As biomarker-directed therapies drive advancements in the oncology space, experts are reviewing cutting-edge trends and strategies that help institutions address ethical and regulatory challenges.

OUTSOURCING MODELS

5 Ways To Make Your Investigator Meetings Fun And Functional

Discover five ways CROs and sponsors can better engage and communicate with site staff for better relationships and better trials.

Why Biotech CRO Partnerships Are Essential For Clinical Trial Success

For early-stage biotech companies, the road from discovery to market is fraught with challenges, and in this environment, strategic partnerships with CROs have become a cornerstone of clinical success.

Accelerate Drug Development With Master Protocols

Through careful planning, aligned incentives, and an open, adaptive mindset, master protocols become powerful engines for accelerating therapies to market—particularly in high-need therapeutic areas.

Quotient Sciences Core Services

Uncover how we're able to bring integrated services and trusted scientific insight to every molecule and program.

Comprehensive Services CNS Drug Development

Our approach is designed to optimize efficiency and accelerate timelines, resulting in up to 40% time savings throughout the early phases of your drug development journey.

Packaging Design And Development Services

We are manufacturing, packaging, and supply chain experts, harnessing experience and expertise to deliver you a seamless solution with the ultimate aim of improving the lives of patients.

SURVEY

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