ur healthcare landscape is rapidly evolving and presenting us with complex challenges: modernizing clinical trials, ethically integrating artificial intelligence, and delivering patient-centric care. No single organization can tackle these issues alone. That’s why industry consortia, such as TransCelerate BioPharma Inc., Clinical Trials Transformation Initiative, and the Innovative Health Initiative, have emerged as powerful engines of innovation and progress, bringing together diverse minds to forge ecosystem solutions.

This isn’t just about the what of industry collaboration; it’s about the how. This article follows the journey of one TransCelerate-developed innovation (download) from concept to adoption: from vision to value. How do sponsors bring industry-developed innovations to life and successfully enable CHANGE without dedicated internal resources?

Case Study

Digital health technologies (DHTs) offer significant opportunities for the pharmaceutical industry to improve every stage of the drug lifecycle, from R&D to post-market surveillance. They span a wide range of uses from general wellness to wearable devices. They might be used as diagnostics or adjuncts to medical products. They might be used to develop or study medical products or to monitor symptoms of disease. They may or may not be regulated as medical devices.

The increasing volume and complexity of safety data from digital ecosystems has seen auditors across industry highlight incomplete, incorrect, and/or inadequate assessments of digital solutions, potentially leading to patient safety impacts, regulatory noncompliance, and reputational risks.

TransCelerate’s vision was to develop a tool to facilitate pharmacovigilance risk assessment in digital health. The goal was to address challenges like adverse event definitions and data privacy while enabling sponsors to systematically navigate patient needs, regulatory requirements, and operational logistics for scalable DHT implementation. As a result, TransCelerate developed a tool that would enable a robust exploration of individual DHTs used in the post-approval setting through the lens of pharmacovigilance professionals, through proposed considerations for enhancing product safety. This work was intended to positively support the industry in understanding the use and impact of DHTs on pharmacovigilance and readiness.

A senior leader from our organization who specializes in digital health and pharmacovigilance volunteered as the TransCelerate co-lead for solution development to ensure our voice was represented. But how could one individual change the mindset and processes of a large global organization alone?

Internally, our first priority was securing an executive sponsor willing to advocate for broadscale adoption by making it a high-level organizational goal. An individual from our quality group with solid pharmacovigilance experience took charge of our internal landscape assessment, stakeholder negotiations, and process revisions. Finally, we launched an organization-wide talent flow campaign: Was it possible to find someone with change-management expertise and an interest in DHTs who ALSO had a manager willing to allocate a percentage of their time for career development? To our delight, the answer was yes!

Thanks to creative resourcing, we had a passionate and diverse team. They were nimble, with vast networks, and together they developed a clear execution plan:

• Customize the industry-developed innovation for our organization: to improve relevance and user experience.
• Integrate the customized tool into our processes: to ensure governance and compliance.
• Assign process ownership: to facilitate oversight and continuous improvement.
• Embed the tool into a web-based platform: to mandate use and track metrics.
• Deploy communication-engagement-training strategies: to support awareness and learning.

Tailoring and adopting this industry-developed innovation across our organization ensures early and continuous evaluation of DHT impacts on patient safety and regulatory compliance. It reduces risks potentially caused by inconsistent processes and lack of awareness. It provides us with a central, easy-to-use platform for all DHT safety assessments, ensuring evidence of due diligence for inspection readiness. Integrating the tool into our quality management system provides clear instructions and accountability.

The platform supports us in derisking pharmacovigilance as we accelerate digital innovation. By safely and effectively leveraging DHTs, we can improve healthcare access, reduce costs, and provide a more personalized approach for patients.

CHANGE isn’t easy, but it IS possible. By applying our CHANGE blueprint, we have transformed an industry consortium vision into a valuable organizational asset. Our approach serves as a repeatable model for future industry-developed innovations. By sharing these learnings, we aim to help others accelerate impact across the healthcare ecosystem.