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.

Welcome to the Parexel Resource Center

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

New FDA Guidance Addresses the Need for Data-Generation Strategies Across the Drug Development Lifecycle

Early planning can help you make the most of expedited regulatory pathways

New endpoints for early-stage cancer are gaining regulatory traction

How emerging biotechs can enter the Chinese market and prosper

Making Expedited Regulatory Pathways Work for Global Drug Development Programs

Biosimilar Development: Are therapeutic clinical trials needed?

What to know about FDA INTERACT meetings

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

Maximize the efficiency of regulatory operations with five key competencies

Maximize the efficiency of regulatory operations with five key competencies

Four reasons to conduct robust natural history studies before clinical trials

Preparing for EU-CTR

3 ways to reap the benefits of adaptive-trials

Real-World Evidence: The Feedback Loop

Links to videos and COVID blog

Patient engagement: Being heard

Drug Development for Rare Disease and Oncology During the COVID-19 Pandemic

Case Study Achieving Product Endorsement after a FDA Warning Letter

Parexel on the Pulse

EU Clinical Trial Regulation 536/2014 Factsheet