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.

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

Multi-stakeholder strategies for external control arms

New ways of thinking are needed about vast sources of data amassed — and how that data can be fit-for-purpose to meet drug approval and access standards.

How a joined-up development strategy pays off for early-stage biotechs

Parexel Biotech’s Nate Akers, VP, Business Development, and Vicky Hsu, Head of Operations in Asia discuss the importance of aligning clinical execution with a clearly defined regulatory strategy.

Navigating COVID-19 to Support Next-Gen Patient-Focused Treatments

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.

Decentralized clinical trials - A more patient-centric approach

Decentralized clinical trials, where portions of a study are conducted outside a traditional trial site, offer new opportunities — and new hope — for patients struggling with inflammatory conditions.

Four Keys to a Smoother Clinical Development Journey

Whitepaper recently published in Fierce Biotech providing perspectives on how the right partner can help bring all the disciplines together for a successful development program.

Entering a new age of evidence generation: synthetic control models

Expert perspectives from Parexel's Leanne Larson, Senior Vice President and WW Head of Real-World Evidence

Real-world evidence for more efficent, patient-focused trials

Parexel's Amy McKee and Leanne Larson make a case for an evidence-driven approach to drug development.

PharmaVOICE - The RWE Evolution

What the industry is currently experiencing is an evolution of processes founded in solid science and good clinical study practices.

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...

Six top tips to prepare for the new EU Clinical Trial Regulation

Parexel Clinical Trial Regulatory Services consultants share what you should be doing now to prepare for the coming changes.

Five competencies for operational excellence in cell and gene therapy clinical trials

What is different about cell & gene therapy trials, and what does it take to operationalize them effectively? We break it down into five competencies you need for success.

How RWE can help Biotechs optimize the value of their asset

Matthew Gordon, VP of Real-World Evidence Strategy, Parexel, and Jimmy Brown, VP, Parexel Biotech discuss how RWE is a tremendously versatile tool for biotech companies at all stages.

Can Chinese Phase I data from the West accelerate China drug development?

The science of ethnobridging – a way to implement cost-effective, multi-ethnic approaches to global clinical trial research and drug development.

Whitepaper: COVID-19 Vaccination in Cancer Patients

In this whitepaper, we address the unique variables, optimal timing, and immunogenic considerations for vaccinating individuals with cancer.