Overview

Decentralized Clinical Trials (DCT) have disrupted our models for clinical trial execution. The ultimate goal is to bring the trial to the patient by seamlessly orchestrating trial activities in an intuitive and seamless user experience for patients, sites, and sponsors.

In this case study, we will explore how a global pharma company leveraged Astrix’s expertise to:

• Delineate current state processes and areas of opportunity.
• Develop a future state, end-to-end strategy for clinical trial orchestration capabilities.
• Execute marketplace assessments and vendor selection.
• Creation of a multi-year roadmap for adoption.

Business Challenge

A top 10 biopharmaceutical company wanted to address the day-to-day challenges of operating with a large number of disconnected sponsor, site, and patient systems, each with its own set of discrete capabilities, integrations, process, and data harmonization. The overall lack of orchestrated workflow-data harmonization results in multiple points of data and duplicative data entry, adding complexity and resourcing with limited ability to manage study activities between sponsor, site, and patient for the study’s Schedule of Activities and milestones.

Opportunity and Scope

The objective is to create the foundation for a platform architecture for solution providers that enables opportunities to orchestrate process, harmonize data, and provide a seamless user experience to all study stakeholders. As such an orchestration tool does not exist in the market today, the client needed to partner with key technology providers to help define, design and drive the new ecosystem. This project focused on understanding and optimizing the current state processes, outlining a future state orchestration ecosystem, assessing the marketplace for potential vendors, driving vendor engagement and selection, and planning a multi-year roadmap for adoption and implementation.

How Astrix Enabled Success

Astrix collaborated closely with the client team and leveraged Astrix frameworks for evaluating and optimizing the current state, defining the future state, and vendor engagement. This resulted in the development of vendor evaluation criteria, project critical success factors, guiding principles, and measures.

Benefits and Impact

The benefits achieved by this Global Pharma organization through this project included:

• Evolving their original strategy to scale and developing alternative strategy by leveraging Astrix’s agile frameworks based on marketplace evaluations and capabilities definition.
• Designing and driving collaboration for the client with the top 10 technology providers to create ground zero for the plug-and-play technology.
• Formalizing key business capabilities for the client, including solution architecture, high-level workflows, requirement documentation and prioritization, data standards, vendor evaluation criteria, project critical success factors, guiding principles, and measures.

This collaborative work resulted in the following:

• Clear understanding of the current state to future state strategy
• Refreshed business cases
• Finalization of a high-level solution architecture
• Role-based workflows and capability maps to support study SoA
• Drafting of a 3–5 year implementation strategy substantiated by PoCs with potential vendors to validate emerging technology
• Facilitation of executive sponsorship & organizational alignment of strategy and implementation approach