Expedited Pathways Comparisons - US EU CHN

Slides presented during virtual roundtable, entitled "Making expedited regulatory pathways work for global drug development programs"

3 ways to incorporate DE&I in your communications strategy

n this infographic, we outline three ways to incorporate Diversity, Equity and Inclusion into your strategy to deliver inclusive communications that connect with a diverse and multicultural audience

Preparing for a Risk-Based Future: What ICH Revisions Mean for Clinical Trial Design and Conduct

In a two-part series, this first paper outlines the quality and regulatory thinking that underpins RBQM, and details essential points of compliance for emerging ICH core guidances on RBQM

What to know about FDA INTERACT meetings

Our regulatory expert and former FDA regulator Steve Winitsky shares his advice on planning and preparing for an effective INTERACT meeting.

Three ways to work with the FDA for better patient-focused trials

Useful practices for getting the most out of your collaboration the FDA

Decentralized trial tools and technologies are here to stay: A regulatory perspective

COVID-19 led to an era of remarkable regulatory flexibility and innovation with Decentralized Clinical Trial (DCT) strategies and tools but are they here to stay? Read more in this article.

Maximize the efficiency of regulatory operations with five key competencies

In this article, Parexel regulatory outsourcing experts explore five competencies companies can use to manage post-marketing regulatory requirements better and more efficiently.

Five tips for effective early engagement with regulators and payers

Lessons from China and the United States on the use of RWE in regulatory submissions

Parexel experts have compiled some lessons learned and share recommendations on how companies can be more effective at collecting RWD and generating RWE in different regions

Can Synthetic / External Control Arms meet regulatory and HTA requirements?

This article summarizes a recent panel discussion where experts from Parexel and biotech company, MorphoSys, shared their experiences from recent pioneering efforts in RWE.

4 insights on decentralized trials for biotechs _ BioPharma Dive.PXRL

How to accelerate oncology clinical trials through site relationships and patient insights

Learn how all stakeholders benefit when patients and their insights are at the heart of every aspect of clinical development.

Top Ten Rules for Success in DCTs

Patients’ needs and insights are central to how we design and conduct trials. Here are our top ten rules for a successful DCT...