Key To A Faster, More Flexible Clinical Trial Process

Introduction

Clinical development teams are under enormous pressure.

Pressure from financial stakeholders, who expect a timely return on their investment; pressure from regulators, who are closely scrutinizing the biopharma industry as it explores new therapeutic platforms; most of all, pressure from patients and their families, who are waiting for much-needed cures and life-enhancing treatments.

As they navigate the lengthy and challenging clinical trial process, study teams need to alchemize these pressures into opportunities for greater collaboration, risk management, and quality. For example, many trial sponsors are responding to increased regulatory scrutiny by moving their medical monitoring activities out of CROs and into their own internal process, which means improved data quality and better cost control. But adapting to these changes while maintaining speed, safety, and data integrity is a challenge that companies of different sizes often experience in unique ways.