The clinical development landscape is rapidly evolving, with hybrid trial approaches and the growing use of RWD/RWE. Clinical trial sponsors are increasingly challenged to manage the vast volume of data generated during multiple, simultaneously running trials. This data explosion, combined with heightened regulatory scrutiny from bodies like the US FDA, is pushing sponsors to take greater ownership in trial oversight, risk management, and patient safety.

The challenge is exacerbated when clinical trials are outsourced, as sponsors lose real-time access to trial data, delaying critical decision-making and risk management. The solution lies in an end-to-end unified clinical Data and Analytics (D&A) platform, which provides a single source of truth by consolidating trial data across multiple solutions, ensuring quality and standardization and delivering real-time trial performance analytics.

This report addresses the key challenges sponsors face in managing clinical data, the benefits of deploying an end-to-end unified clinical D&A platform, and implementation considerations. It is tailored to assist biopharma and MedTech enterprises, as well as contract research organizations, in streamlining their clinical data management, enhancing trial oversight, and improving decision-making.

Scope

• Industry: life sciences
• Geography: global

Contents

In this report, we outline:

• The business challenges that sponsors face in managing clinical data
• An end-to-end unified clinical D&A platform’s benefits
• Key implementation considerations for clinical D&A platforms

Membership(s)

Clinical Development Technology

Life Sciences Information Technology

Sourcing and Vendor Management