Bree Burks of Veeva Systems Discusses What Clinical Trials Will Look Like Post COVID-19
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Published: September 9, 2020
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This video explores the significant transformation of clinical trials post-COVID-19, highlighting the accelerated shift towards remote, decentralized, and virtual models. Bree Burks from Veeva Systems discusses the historical challenges faced by research sites, particularly their reliance on manual, paper-based processes and the lack of dedicated technology budgets. She emphasizes Veeva's approach to empowering sites and patients through purpose-built, affordable technology like SiteVault Free for eRegulatory management and MyVeeva for patient engagement. A major theme is the inefficiency of the study startup process, which accounts for a disproportionate amount of trial time due to manual workflows and disconnected systems, underscoring the critical need for standardization and unified technology platforms across the industry.
Key Takeaways:
- Accelerated Decentralization: The COVID-19 pandemic significantly accelerated the adoption of remote, decentralized, and virtual clinical trials, making patient and site-centricity paramount in trial design and technology implementation.
- Site Empowerment Through Technology: Research sites historically lacked adequate technology and operated with limited financial reserves. Solutions like Veeva's SiteVault Free provide essential, affordable tools for sites to standardize, go paperless, and manage remote monitoring, enabling them to operate more efficiently and sustainably.
- Critical Study Startup Inefficiencies: Study startup accounts for a staggering 61% of total trial time, primarily due to manual processes (75% prevalence), heavy reliance on error-prone spreadsheets (81%), and a lack of transparency and connected systems between sponsors, CROs, and sites.
- The Imperative for Standardization and Unified Platforms: To overcome operational drag and reduce "one-off" approaches to studies, there is a strong need for standardization of processes and the adoption of seamlessly unified technology platforms that facilitate automated data and document exchange across all stakeholders.
- Patient-Centric Technology for Accessibility: New technologies like MyVeeva aim to bring clinical trials directly to patients, particularly those in rural areas or with rare diseases, by enabling virtual visits and streamlined communication, thereby enhancing diversity and accessibility in trials.
- Technology Must Simplify, Not Complicate: The ultimate goal of technology in clinical trials must be to simplify site operations and reduce administrative burden, allowing sites to remain focused on patient care and accelerate therapy development, rather than creating additional bureaucratic layers or compliance concerns.