Safety First: Scaling Up Oncology Solutions with Seamless Transition

Safety First: Scaling Up Oncology Solutions with Seamless Transition: Case Study Overview

APCER Life Sciences played a pivotal role in supporting a US-based oncology-focused biotechnology company with a global footprint and a portfolio of innovative cancer therapies.

The company was facing significant challenges in maintaining clinical safety standards while meeting regulatory and partner submission deadlines, compounded by a substantial backlog of clinical trial cases. These issues were caused by several converging factors:

• An addition of a new molecule or an indication,
• Difficulty in scaling up inhouse resources to manage the surge in volume of clinical trials leading to a backlog (2000+ non-reportable cases),
• Continued struggle to meet regulatory and partner submission timelines, putting clinical safety compliance at risk.

To address these concerns and ensure uninterrupted clinical safety operations, the client engaged APCER Life Sciences for strategic support. APCER provided expert case management services, helping the client maintain high-quality clinical trial documentation, meet submission deadlines, and uphold global clinical safety and compliance standards.

Leveraging its deep pharmacovigilance expertise and scalable operational model, APCER provided targeted support to streamline case processing, enhance compliance, and accelerate turnaround times. This collaboration not only helped clear the backlog efficiently but also ensured timely and high-quality submissions to regulatory authorities and partners—reinforcing APCER’s position as a trusted partner in global drug safety.

Managing Surge in Case Volumes while Maintaining Quality During Clinical Trial Phases: Case Study Highlights

The APCER Team implemented a multifaceted approach involving operational scaling, effective resource allocation, and effective project management methodologies to mitigate the surge in volume while maintaining quality and compliance. With pre-analysis and established bench strength, APCER ensured smooth volume management.

This integration facilitated the seamless transfer of information between the two teams, enabling the early identification of potential safety concerns and allowing proactive risk management strategies. Consequently, the following steps were taken:

• Seamless Transition and Ramp-up Plan: A structured ramp-up plan was developed in collaboration with Operations and Project Management Teams to ensure a smooth transition.
• Onboarding and Training: Over a 6-month period, resources were onboarded per the agreed project plan. Experienced team members from post-marketing case processing were reallocated and cross-trained for clinical trial cases. Parallel training was conducted for the new hires, with backfilling arranged to maintain post-marketing operations.
• Project Monitoring and Client Collaboration: Weekly and biweekly progress reviews fostered a close collaboration with the client. A phase-wise handover of clinical trial cases was executed, with each milestone achieved successfully.

How Can APCER help in your Clinical Phase Journey with its Integrated PV Solutions

APCER Life Sciences brings together a team of highly qualified healthcare professionals with multi-therapeutic expertise in pharmacovigilance.

Our specialists are adept at managing expansive portfolio coverage across diverse product types, leveraging fully integrated and validated technologies to ensure seamless operations.

Through our efficient project management approach—anchored by the unique “two-in-a-box” model—we consistently deliver on timelines while maintaining agility and precision.

Above all, our team is committed to producing high-quality, consistent, and impactful deliverables that meet the highest standards of regulatory and partner expectations.