Background
In Search of a Strategic Partnership
A specialized biotechnology sponsor headquartered in France, with a strong global mission to advance immunotherapies for cancer patients, specifically those suffering from Non-Hodgkin's Lymphoma and solid tumors, was in search of a strategic partnership with a Contract Research Organization (CRO). After a thorough evaluation, the company chose Novotech to oversee its Single Country Phase 1 study for solid tumors, and later, to manage its multi-country clinical trials for Non-Hodgkin’s Lymphoma. This decision was rooted in Novotech's demonstrated success in the field of oncology and its substantial expertise in the management of global clinical trials.
Phase I Single Country Clinical Trial Achievements
In the Phase 1 Single Country solid tumor study in South Korea, Novotech effectively achieved the targeted patient enrolment, marking a significant accomplishment by reaching the crucial Last Patient Last Visit (LPLV) milestone. The team presented an interim dataset that was both timely and precise, surpassing the sponsor's expectations and garnering praise for their dedication, responsiveness, and high standard of work.
Multinational Phase I/II Strategy and Anticipated Outcomes
Strategy
Recognizing the significance of the Multinational Phase I/II trial, and its comprehensive scope incorporating clinical trial management, regulatory compliance, pharmacovigilance, and medical monitoring, Novotech tailored the approach to ensure an expeditious and efficient delivery of Phase I/II.
The trial comprises Phase I dose escalation across 10 sites, dosage evaluation at 20 sites, and subsequent Phase II implementation across 34 sites, anticipating enrollment of around 179 patients. Recruitment for the various phases is scheduled to extend from November 2023 to December 2027.
Anticipated Outcomes
The partnership between Novotech and the sponsor holds the potential to deliver a range of anticipated outcomes and transformative achievements. Leveraging global resources across APAC, Europe, and the US, Novotech secured swift regulatory approvals and conducted site initiation visits as scheduled. A robust relationship with Principal Investigators (PI) have also strengthened site relations for the sponsor expediting feasibility activities and projecting accelerated clinical trial timelines. The collaborative effort aims to generate timely and efficient results, offering a streamlined process that presents a significant advantage for the project by potentially expediting critical milestones and delivering tangible benefits to the sponsor.
Conclusion
Novotech CRO: The Leading Choice for Solid tumors and Non-Hodgkin's Lymphoma Clinical Trials
Novotech's broad expertise across a range of solid tumors and haematological cancer conditions, spanning from follicular lymphoma to diffuse large B-cell lymphoma, highlights its proficiency in this therapeutic area. The primary aim now is to contribute to the trial's success.