Fuel Clinical Advances Next Phase of Phase 1 Prostate Cancer Study by Defining and Driving Protocol Amendment Requirements
Published: September 2026
TORONTO, September 2026 — Fuel Clinical today announced its continued role in an ongoing Phase 1 prostate cancer clinical study, following completion of a revised protocol amendment and preparations to enroll additional subjects beginning in September 2026.
The latest phase of the program builds on Fuel Clinical's work with the sponsor in late 2025, when the Fuel team was brought in to rapidly configure and deploy the study's Electronic Data Capture (EDC) environment and provide Data Management, Data Analytics, Biostatistics and related clinical development services.
Working against an aggressive study timeline, Fuel completed the EDC configuration and validation in under 60 days, helping the sponsor achieve its First Patient In (FPI) objectives in December 2025.
Since that initial milestone, Fuel has continued to play an integral role in the study and has now helped define and drive the requirements for a revised protocol amendment designed to advance the next stage of the Phase 1 program. Additional subjects are expected to begin enrolling in September 2026, with the expanded study continuing within Fuel's EDC environment.
This is a great example of what we mean when we talk about engineering the success of a study. Our initial objective was to move quickly and give the sponsor the technology and operational foundation needed to achieve FPI. Nine months later, we remain deeply involved in the program, helping the team define the requirements for the next phase, adapt the protocol, expand the study and prepare for the next group of subjects.
Andrew Schachter
|Founder & CEO, Fuel Clinical
Fuel's approach emphasizes starting with the end in mind and connecting clinical strategy, operational execution, biometrics and eClinical technology around the information ultimately required to successfully execute and evaluate a clinical study.
For this program, the continuity between protocol development, EDC configuration, Data Management, Data Analytics and Biostatistics allows changes to the clinical strategy to be translated directly into the systems, data and processes driving the study.
Early-phase studies are dynamic, and changes to a protocol can have implications across data collection, statistical strategy, technology and study operations. Having the clinical, biometrics and technology teams working together allows us to understand those implications early, define what is required and implement the changes in a coordinated way. That continuity is particularly important when a sponsor needs to move quickly without compromising the quality of the data or the integrity of the study.
Erika Passi
|Global Head of Biometrics, Fuel Clinical
About Fuel Clinical
Fuel Clinical's services begin with Unified Intelligence Strategic Planning, helping sponsors start with the end in mind by defining the clinical, operational, biometrics, data and technology strategy required to achieve a successful study outcome.
From that foundation, Fuel provides integrated Clinical Operations, Data Management, Biostatistics and Statistical Programming, Data Analytics, Safety and Pharmacovigilance, and a comprehensive suite of eClinical technologies including EDC, RTSM/IWRS, CTMS, eTMF, ePRO/eCOA, Safety Database and Clinical Trial Payments solutions.
Through its Unify platform, Fuel connects these capabilities and critical study data within a coordinated environment, giving sponsors greater visibility into study performance and the information needed to make timely, informed decisions throughout development.