Clinical trials necessitate extensive planning and involve managing multiple sites, stakeholders, a complicated technology ecosystem, and compliance in a highly regulated environment. Introducing a new drug to the market is a lengthy and laborious procedure that is often accompanied with a significant price tag, averaging around US$2.4 billion. The recent pandemic has significantly influenced clinical trial design and conduct, resulting in a rapid uptake of digital technologies, data science, analytics, and automation tools that improve the efficiency of trial management and workflows. However, the clinical development landscape still has a long way to go, as it remains overly complicated with numerous disconnected systems. This leads to challenges such as data silos, concerns regarding data security and privacy, and the persistence of conventional approaches to data analysis.

The unified end-to-end clinical development approach offers a comprehensive solution for efficient trial management that integrates all the necessary solutions for clinical, safety, and regulatory activities with a unified data layer. This approach provides several benefits such as reduced data silos, lower total cost of ownership, and a streamlined product landscape, thereby minimizing the need for integration and custom development activities.

This report examines the concept of an end-to-end approach in clinical development, provides insights into current technology implementations, and offers a roadmap for successfully implementing these platforms.

Scope

• Industry: life sciences
• Geography: global

Contents

In this report, we:

• Examine the concept of an end-to-end approach in clinical development
• Provide insights into the current state of the unification journey
• Present enterprise expectations from end-to-end clinical development platforms
• Offer a roadmap for successfully implementing these platforms

Membership(s)

Life Sciences Information Technology

Clinical Development Technology

Sourcing and Vendor Management