ABC Oncology Clinical Trial Safety Monitoring Committee Case Study

Case Study Introduction

With growing pipelines and internal resource constraints, biotechnology companies are at risk of internal challenges of meeting tight timelines to achieve the regulatory approval which they aim for. This is magnified in complex studies such as Antibody-drug conjugates (ABC) oncology studies where regulations shift with concepts such as Project Optimus and operational challenges of toxicity management.

This case study focuses on the challenges and outcomes of biometric support for Safety Monitoring Committee (SMC) meetings. The support for the SMC was requested in addition to the ongoing delivery of clinical data management services, biostatistics services and programming support on a dose-finding Phase I ADC oncology trial.

Objectives and Key Challenges

Quanticate was originally contracted to provide full-service Biometrics support for the sponsor’s Phase I dose-finding ADC oncology trial due to the sponsor’s lack of internal capacity.
After work began, the sponsor requested extra help with running a Safety Monitoring Committee (SMC) as they did not have the necessary in-house expertise, Quanticate assumed these additional responsibilities.

Findings from the SMC triggered 11 protocol amendments, each of which had to be implement within one month to keep patient recruitment costs down. In addition, there were multiple points of contact across the sponsor’s CDM and S&P teams which created project management challenges of keeping all the stakeholders and POCs aligned and aware of the study progress.

Strategic Approach and Tailored Solutions

Quanticate supported this complex multi-part ADC oncology trial by serving as the central coordination hub across multiple stakeholders and vendors due to the multiple points of contacts across the sponsors teams. As a biotech sponsor they operated under a lean model with several points of contact, so we applied a structured governance framework to consolidate communication, resolve conflicting instructions and maintain study momentum.

Over the course of 36 months we deployed 11 EDC databases and managed seven vendor data streams with 21 individual files. Our team developed a vendor management plan and held face-to-face sessions to address process gaps, including a central lab that lacked a standard approach for tracking sample shipments or sharing lab data.

Quanticate advised on the protocol design, helped define inclusion and exclusion criteria and reviewed the proposed statistical analyses. Our Statistics and Programming team merged EDC and CTMS data to generate protocol deviation listings in support of regular SMC meetings. There were held approximately every three months following the last visit in each cohort of four patients.

SDTM datasets were delivered each month by our team, from the first-patient-first-visit onwards. We used an automated process to reduce cost while maintaining strong data quality checks. Working closely with the sponsor’s clinical team, we ensured that data entry and cleaning were completed within 24 to 48 hours.

A mid-study database lock was completed with one month’s notice and delivered the RP2D lock within one week of last-patient data. We also maintained individual study-level and portfolio-level database lock plans to ensure clear oversight throughout the trial.

Successful Client Outcomes

Due to the support and delivery of Quanticate’s team, the sponsor saw multiple benefits from partnering with Quanticate.

The SMC Listings created by Quanticate were highly automated and robustly programmed to allow a very quick turn around on the unique deliverables for SMC.

The 11 protocol amendments from the SMC findings were delivered on time despite the one month timeline as Quanticate delivered every amendment on schedule.

In addition, Quanticate successfully supported both the RP2D and final database locks for this two-part oncology study, which included seven disease-specific cohorts across dose escalation and expansion phases. Despite the protocol’s complexity and multiple amendments, we ensured timely, inspection-ready data delivery through proactive data cleaning, cross-functional coordination and adaptive planning. Therefore the client was able to submit the expansion study to the regulatory authorities due to Quanticate’s quick turn around of the PR2D deliverable.

Conclusion

Our approach standardised communication, closed process gaps between labs and platforms, and shortened the distance from data entry to decision. This resulted in a faster, more confident dose-escalation progress and smoother transitions into expansion phases. If your early-phase pipeline demands speed and control in equal measure, we can bring the same structured delivery model to your next study.

Full Biometric support for Safety Monitoring Committee (SMC) of a dose-finding Phase I Antibody-Drug Conjugates (ABC) Oncology trial

Case Study Introduction

Objectives and Key Challenges

Facing tight regulatory deadlines?

Strategic Approach and Tailored Solutions

Successful Client Outcomes

Conclusion

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