Protas launches novel unified clinical trial management platform

Coupled with a major milestone for its first users, Protas announces the launch of the Cantata platform.

Cantata is a new, integrated platform built by Protas to transform an industry hampered by antiquated approaches to information technology (IT).

It takes a holistic, real-time approach and covers clinical trial activities in their entirety, from participant enrolment, consent and randomisation through to final follow-up assessments.

It spans the full range of logistical, oversight and quality assurance needs, from site management and training, through drug supply, laboratory and logistics management, to clinical oversight, monitoring and pharmacovigilance.

With a single, real-time data infrastructure and fine-grained access controls, Cantata provides seamless workflows that render the protocol, operating procedures and trial activities as software code.

This automation and integration improve the quality and efficiency of clinical trials, thereby reducing costs, while enhancing the overall experience for staff, clinicians and trial participants alike.

Ultimately, it increases the likelihood of trials that use the platform to yield reliable and informative results.

Protas’ mission is to tackle the global burden of common and life-threatening diseases by enabling clinical trials to have the best chances of success.

Outdated IT is one of the principal reasons clinical trials are so burdensome and costly, often failing to yield results of the quality needed to change clinical practice. Cantata was built as a solution to that problem.

The first users of the new platform are the UK’s Oxford Population Health and German pharmaceutical company Boehringer-Ingelheim for the recently launched EASi-KIDNEY™ trial.

EASi-KIDNEY™ is the world’s largest study into chronic kidney disease (CKD) and will take place across 15-20 countries worldwide with 11,000 participants expected to take part.

EASi-KIDNEY™ launched in September last year, and this January has started the process of randomising participants – a major milestone for both the trial and Cantata.

Prof Sir Martin Landray, Chief Executive Officer of Protas, said: “Protas was set up at the height of the COVID-19 pandemic to transform clinical trials for common and life-threatening diseases at scale, and Cantata is fundamentally important to that mission.

“In recent years we have seen the number of large clinical trials for common diseases plummet due to escalating costs, largely due to poor IT integration. This is placing the health of millions of people at unnecessary risk and putting substantial pressure on healthcare systems around the world.

“Cantata provides a timely and much-needed solution to that problem, and we are already working with leading organisations to help them get the best of what the platform has to offer.”

Cantata, built in partnership with the business and technology consultancy, Slalom, extends an approach initially developed by Sir Martin and colleagues at Oxford Population Health.

Protas and Slalom have combined that prior Oxford experience with Salesforce cloud services to develop Cantata and drive new progress in clinical trials.

Will Herrington, Professor of Clinical Trials and Epidemiology of Kidney Disease at Oxford Population Health and Chief Investigator for the EASi-KIDNEY™ trial, said: “Roughly 850 million people worldwide are living with chronic kidney disease, which currently has no cure.

“Additional treatments are urgently required. The EASi-KIDNEY™ trial will enable us to find out whether a new treatment called vicadrostat (also known as BI 690517) can help slow the progression of chronic kidney disease when it is taken in combination with empagliflozin, a treatment that is recommended now for most adults with CKD worldwide.

“One of the biggest challenges in modern clinical trials is the lack of integration across IT systems and data points. This can be challenging particularly for large, multi-site trials that need to combine data from multiple sources.

“By providing an end-to-end trial management platform for the first time, Cantata is enabling us to protect data quality, while increasing collaboration and improving the experience for patients and clinicians alike.”