Phosphate Therapeutics Selects Clinipace Worldwide to Manage its Phase 2 Renal Study
Therapeutically-Focused Clinical Development Team Leverages Technology-Amplified dCRO Model to Streamline Efficiencies, Reduce Development Costs
Clinipace Worldwide, a global digital clinical research organization (dCRO), announced today that Phosphate Therapeutics, co-owned and resourced by Shield Therapeutics (Shield), an independent specialty pharmaceutical company, has selected the company to manage its first pivotal trial in its late stage Nephrology program expected to commence in 2014.
Clinipace will manage a pivotal trial of PT20, a novel iron-based phosphate binder being developed for the treatment of hyperphosphataemia related to chronic kidney disease (CKD).
Hyperphosphataemia is a life-threatening complication of CKD, the incidence of which is increasing globally as obesity and diabetes levels rapidly rise. The treatment of this condition is a significant unmet medical need, providing a strategic opportunity for Phosphate and Clinipace to partner in research.
“Given the gravity of the disease under study, and significant therapeutic promise shown by PT20 in early research, it was crucial for us to work with a provider that could help us complete this pivotal study quickly and effectively in order to reduce the development risk associated with the PT20 programme. We look forward to working with Clinipace on this important study,” said Julian Howell, Group Medical Director, Phosphate Therapeutics Ltd.
“With the rising incidence and prevalence of kidney disease, poor outcomes and high costs associated with treatment are putting undue burdens on the global healthcare system,” said Jeff Williams, CEO, Clinipace Worldwide. “With much of the expense of bringing promising drugs like PT20 to market related to the cost of clinical trials, we offer not only an experienced, therapeutically-focused team but a technology-enabled services approach, our dCRO model, to ensure the trial is optimized for budget and visibility while it is being conducted.”
Empowering Sites and Patients: The Impact of Personalized Support in Clinical Trials
November 26th 2024To meet the growing demands of clinical research, sponsors must prioritize comprehensive support models, such as clinical site ambassadors and patient journey coordinators, who can address operational challenges and improve site relationships, patient satisfaction, and overall trial efficiency.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
FDA Finalizes Decentralized Clinical Trial Guidance
November 25th 2024The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
