Background
In a high-stakes Phase III multiple myeloma study, a top-five biopharmaceutical company engaged WCG to deliver independent adjudication services.
Adjudication committees provide objective and standardized review of major clinical events, mitigating risk with reliable, regulator-ready data required for key study submissions. Without expert adjudication support, sponsors risk delaying key trial milestones or even missing first to market advantage. Fortunately, working in close partnership with WCG’s adjudication team, this sponsor hit a major milestone, meeting one of their primary endpoints.
The Challenge
While WCG was entrusted with supporting multiple studies for the sponsor, this pivotal multiple myeloma trial rapidly emerged as the sponsor’s primary focus, particularly as it required timely regulatory reviews. Faced with
rigorous requirements, a high volume of events, and compressed timelines, WCG’s adjudication experts demonstrated exceptional agility and partnership. Over just eight months, WCG processed and adjudicated more than 13,000 visits for this trial, meticulously managing the workflow across six data batches.
With one of the most mission-critical batches ahead of a database lock (DBL), WCG efficiently processed a high volume of events under
an extremely tight turnaround to meet the sponsor’s timeline. The sponsor provided data for approximately 220 subjects, totaling nearly 5,000 individual visits.
Strategic Solutions
WCG responded with agility and true partnership, employing several critical strategies.
- Collaborative Process Modification: Working together with the sponsor to adjust all adjudication workflows, WCG compressed front-end and back-end tasks to maximize committee review time. This ensured required regulatory deadlines were met, even with the high volume.
- AIMS System: The interactive data review (IDR) feature in WCG’s newly updated Adjudication Information Management System (AIMS) streamlined committee member tasks and improved data flow and transparency, enabling the sponsor to view comprehensive feedback and efficiently move their study forward.
- Accelerated Programming and Reconciliation: WCG’s team condensed complex programming, subject reconciliation, and processing tasks, work that typically took a week, into a single day when needed. With this shortened timeline, committee members had the maximum time for voting.
- Flexible, Responsive Operations: WCG accommodated ad hoc requests and implemented interim system signature processes, consistently aligning activities to sponsor requirements and regulatory demands. This adaptability was crucial in maintaining momentum throughout the project, ensuring efficiency without compromising quality.
- Unmatched Adjudication Expertise: The interaction, knowledge-sharing, and historical program oversight provided by WCG gave the sponsor confidence and continuity amidst a rapidly evolving clinical landscape.
Impact & Results
WCG provided every deliverable on time, repeatedly exceeding expectations even under compressed timelines and in the face of large data sets.
- 220 subjects with nearly 5,000 visits made up one critical batch, which was adjudicated and delivered in under 10 days, demonstrating our commitment to meeting urgent client deadlines without sacrificing quality.
- More than 13,000 clinical events were adjudicated by WCG for this multiple myeloma study alone in six months, showcasing unmatched scalability.
- Deliverables were posted to the committee within one to three days of receiving data from the sponsor, ensuring maximum voting time for committee members and minimizing operational risks.
- 100% of key regulatory and sponsor milestones were met, enabling timely submission, supporting trial integrity, and earning strong sponsor confidence.
Client Feedback
I really appreciate you and the WCG team doing everything so speedily to get the decision report to us for our review, and we’re especially grateful for all the work that went into achieving the numerous successful DBLs. The collaboration throughout this project has been exceptional, something I’ve already shared with my management. The WCG team is fantastic!”
Clinical Scientist
Top-Five Biopharmaceutical Company
Conclusion
WCG’s expert adjudication committee and high-touch operational approach were instrumental in the sponsor’s success, delivering reliability, speed, and data quality at unparalleled standards. With deep program knowledge, innovation in technology, and flexible, client-centric processes, WCG continues to be a trusted partner in advancing impactful clinical research.
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