Just in Time GCP Spotlight: Veeva R&D and Quality Summit 2025
The Just in Time GCP team attended the Veeva R&D Quality Summit in Boston, where we proudly served as a Gold Sponsor. The Summit was an exciting experience. It offered a chance to engage with Veeva experts, partners, and users, and to see innovations shaping the future of clinical operations.
Key Industry Themes in Clinical Operations
The Summit underscored the industry’s accelerating shift toward unified digital platforms, TMF oversight, automation, and site standardization. Life sciences organizations are breaking down silos and improving trial inclusivity. They are also preparing for the next wave of AI-enabled clinical innovation. Veeva leaders shared their vision on how sponsors can achieve this:
Process Excellence & Automation – Standardized, automated workflows connecting clinical, regulatory, safety, and quality domains to reduce manual effort and accelerate trial execution.
Diversity in Clinical Trials – Meeting FDA Diversity Action Plan requirements with flexible designs and unified data systems.
Site Standardization – Simplifying sponsor-site interactions through consistent engagement tools, reducing burden and boosting capacity.
CRO Transparency – Sponsors increasingly expect real-time access to CRO data for stronger oversight and inspection readiness.
Roadmaps & Innovation – Veeva unveiled platform enhancements including AI agents, automation of data capture, and APIs for seamless integration.
Client-led sessions reinforced these themes, highlighting how a standardized Veeva Vault platform drives operational excellence and regulatory compliance in clinical trials.
What’s Next for Veeva Clinical Operations and TMF Oversight
Veeva shared upcoming roadmap features for eTMF management, study startup, and inspection readiness:
eTMF / Study Startup Enhancements: risk-based document QC, self-evident corrections, bulk actions, full audit trail exports, and direct integration with Veeva eCOA.
AI for TMF and QC: QC Agent to automate risk-based quality checks, TMF Intake Agent to classify and file documents, and Document Generation Agent to streamline standardized trial records.
As a Preferred Veeva Partner, Just in Time GCP helps sponsors make the most of these capabilities. We draw on more than 20 years of GCP expertise to guide every step. Our team shares proven best practices and tailored recommendations. In addition, we design fit-for-purpose TMF oversight strategies. These strategies strengthen inspection readiness and make operations more efficient.
Product Spotlight: Veeva Basics
One highlight was the debut of the Veeva Basics track. Designed for leaner sponsor teams, it showcased Quality Basics, RIM Basics, and Clinical Basics — solutions built for speed, simplicity, and sustainability in clinical operations.
Key takeaways included:
Rapid time to value: Go live in under 30 days with pre-configured solutions.
Future-proof compliance: Veeva maintains configuration to keep teams inspection-ready.
Fit-for-purpose approach: Smart limits that prevent “outgrown systems.”
Built-in support ecosystem: SOP templates, video training, and 24/7 support.
For sponsors and emerging biotechs, Basics offers an entry point into the Veeva ecosystem — but true adoption means aligning processes, embedding compliance, and ensuring inspection readiness. That’s where Just in Time GCP partners with sponsors to tailor SOPs, lead change management, and maintain TMF data quality.
Closing Thought
The Summit reinforced how quickly the industry is moving toward a connected, patient-centric, inspection-ready future. Together with Veeva, Just in Time GCP is committed to helping organizations improve TMF completeness, quality, and timeliness — advancing both clinical development efficiency and regulatory confidence.
Written by Tess Platt, Senior Business Analyst, Just in Time GCP
AI with Purpose, Not Hype
At Just in Time GCP, we’re taking the themes of AI and automation beyond the hype — click here to see how our innovations are reshaping TMF oversight and inspection readiness.
