CG Oncology Achieves Efficiency with CRO Oversight and Collaborative Safety Solution

CG Oncology is a late-stage clinical biopharma focused on developing and commercializing its potential bladder cancer therapy, now in a Phase 3 clinical trial. To help its in-house safety team scale with speed, the company partnered with CRO Catalyst Clinical Research, LLC (Catalyst Safety) to outsource case intake, data entry, and quality control. By collaborating with Catalyst Safety in the same safety system, CG Oncology is improving efficiency while maintaining oversight with direct access to safety data and processes.

Real-time direct oversight for inspection and audit readiness

For Pradnya Gunjotikar, CG Oncology’s PV manager, Veeva Safety is part of her daily routine, providing a complete view into safety data, end-to-end case processing, and submissions. Upon receiving a serious adverse event (SAE) alert, she can review the case — including case details — and monitor its progression. “I check on case status, conduct medical reviews, and perform quality control (QC) review, all within Veeva Safety,” said Gunjotikar. “I can easily see changes between case versions, which is essential for review.”

With direct access to the safety solution, CG Oncology reduces overhead for safety oversight and can track timelines for regulatory compliance. The safety team has more time to analyze data, resolve issues, and improve safety outputs to support inspection and audit readiness.

“The real-time dashboards and reports are intuitive. I can easily present the high-level data to leadership and the review board, or drill into the data for more information.” – Pradnya Gunjotikar, PV Manager, CG Oncology

Efficiently collaborating within one safety system

CG Oncology and Catalyst Safety can easily and efficiently collaborate and provide transparency to both parties using a cloud-based safety solution. CG Oncology can refresh Catalyst Safety’s custom reports anytime with Veeva Safety, saving significant overhead to get the latest safety data or case status.

Both the sponsor and CRO can track operational metrics, such as case handling time and the number of initial cases and follow-ups received on a weekly, monthly, or per-study basis. Data visualizations provide an operational overview and are useful for stakeholder communication. “The real-time dashboards and reports are intuitive,” said Gunjotikar. “I can easily present the high-level data to leadership and the review board, or drill into the data for more information.” Gunjotikar also uses the SAE reconciliation and query management reports daily to improve data quality.

The Catalyst Safety team uses the reports to effectively manage workload. ”We use the case list every day to track case volume, progress, and prioritize cases such as suspected unexpected serious adverse reactions (SUSARS),” said Lisa Dawson, senior director of safety, Catalyst Safety.

Simplifying safety with a unified solution and automation

Managing adverse event intake to case processing and regulatory submissions within Veeva Safety simplifies the user experience. It is easier to train users and improve productivity. Eliminating manual handoffs also reduces the risk of errors and provides greater control and end-to-end visibility.

Additionally, CG Oncology uses submission and distribution rules to automatically submit individual case study reports (ICSRs) to health authorities, including submissions to the FDA, as well as auto-distribute safety reports to partners. The submission and distribution reports in Veeva Safety enable CG Oncology to easily confirm that all partners have been notified of safety events in a timely manner.

Continuing to improve safety and outsourcing processes

The partnership with Catalyst Safety gives CG Oncology visibility to monitor KPIs and prepare for upcoming deadlines with minimal effort. As Phase 3 of one study concludes, with plans to file for a biological license application (BLA), the flexibility of Veeva Safety allows CG Oncology to support safety through clinical trials and commercialization.