Clinical trial complexity is growing as the industry adapts to COVID-19 disruptions, increasing data sources, and evolving patient expectations. Add on the fact that many studies are conducted across international borders and involve more stakeholders than ever, and streamlining trial processes is even harder. Hugo Cervantes at Veeva Vault Clinical explains how clinical operations teams are advancing study management by adopting new strategies and technologies that bring together data, processes, and workflows to streamline trial execution.

Extract:

‘Modernising Study Management for Greater Visibility and Speed in Trials’

Clinical trial complexity is growing as the industry adapts to COVID-19 disruptions, increasing data sources, and evolving patient expectations. Add on the fact that many studies are conducted across international borders and involve more stakeholders than ever, and streamlining trial processes is even harder.

Coordinating between sponsors, CROs, multiple sites, and patients has become almost unmanageable using paper-based and manual processes. Clinical operations teams are advancing study management by adopting new strategies and technologies that bring together data, processes, and workflows to streamline trial execution.

The Problem

Complexity at the heart of clinical operations

Today’s trials have complicated protocols, generate larger amounts of data, and span several geographies and diverse regulatory requirements. This makes real-time reporting a significant challenge since insights are required within shorter timeframes more often. (Figure 1 shown in the downloadable PDF)

Most clinical operations teams cannot cope with these requirements because of legacy solutions that support outdated, paper-driven, and onsite processes. Key challenges include:

• Delays: Too much time is spent capturing and tracking protocol deviations or follow-up items for trip reports, reconciling information, and double-checking reporting accuracy.
• Productivity issues: Clinical teams are turning to disparate systems and processes, including local file shares and emails, to collaborate because existing systems are too hard to use or cannot adapt to changes quickly enough.
• Productivity issues: Clinical teams are turning to disparate systems and processes, including local file shares and emails, to collaborate because existing systems are too hard to use or cannot adapt to changes quickly enough.

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