Synthetic Control Arm Case Study

1st ever comparator cohort study submitted for regulatory submission and labeling of product

IMP shortage Case study

Ensuring continuity of supply to patients despite IMP shortage

Sample logistics Case study

Worldwide sample logistics and analysis

China Capabilities

Japan Capabilities

Medical Communications Capabilities

Risk-based Quality Management (RBQM) Capabilities

Decentralized Clinical Trials Capabilities

Regulatory Consulting Capabilities

EU-CTR Capabilities

EU-CTR Capabilities

Decentralized Clinical Trials Capabilities

Clinical Trial Supplies & Logistics Capabilities

Clinical Trial Supplies & Logistics Capabilities

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

Parexel Biotech Factsheet

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.