Simulation can optimize trial design, ensure patient safety, says MMS

Simulating trials before starting them helps optimize protocol development, speed up recruitment, and enhance the chances of winning approval, according to Uma Sharma, CEO of MMS Holdings.

Sharma outlined the potential benefits just weeks after the Michigan-based CRO gained a trial modeling and simulation platform called KerusCloud through the acquisition of Northern Ireland-based developer Exploristics.

“The KerusCloud platform was appealing because it strengthened our ability to offer clinical program and trial design strategies for our clients.

“This acquisition allows us to be nimble and competitive, with data-driven statistical modelling and simulation, supported by expert consulting on optimizing the regulatory pathway for the designs chosen,” she told Clinical Insider.

Sponsor demand for model-driven study development is growing, according to Sharma, who cited increasing pressure to make drug research safer as a key dynamic.

“We are now able to offer our clients advanced statistical modeling and outputs which helps them with initial study design, rapid de-risking as enrollment progresses based on data-driven simulations, and ongoing evaluations for DSMBs [data safety monitoring boards] and other safety and efficacy-driven strategy pivots,” she said.

Client expansion

In addition to bolstering MMS’ technical capabilities, the Exploristics acquisition will also expand the CRO’s customer base, according to Sharma.

“There is partial overlap between our customer bases, therefore, MMS will add customers as a result. Additionally, across our customer portfolios the acquisition will enable legacy MMS and Exploristics customers to access wider and more comprehensive end-to-end clinical trial solutions from a data and regulatory perspective.

“Historically, MMS has been a leading player in end-game submissions (NDAs/BLAs) globally, and we can bring that to Exploristics clients who were largely at the study level,” she continued.

Sharma added, “We also intend for new clients, both small and emerging biotech as well as new platforms and portfolios within large pharma, to take advantage of our combined offering to optimize and accelerate clinical programs.”

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