CANTON, Mich. (August 3, 2023) – TrialAssure, a leading software-as-a-service (SaaS) provider advancing clinical trial disclosure, data sharing, and transparency, announced today that it is collaborating with MMS, a global clinical research organization, on a new artificial intelligence (AI) initiative aimed at developing generative text specifically for medical writing in the field of drug development.

The primary focus of this collaboration is to utilize AI to generate text specifically tailored for creating plain language summary (PLS) documents. These documents help clinical researchers effectively communicate their findings with patients, families, and the public by presenting the results in a manner that is easily understandable to the average reader.

“TrialAssure is the perfect partner in this space. Their AI knowledge and their AI-enabled software will allow us to co-create a solution that doesn’t exist in the market today – a tool that generates plain language summaries or other clinical documents automatically,” said Teresa Cesena, Ph.D., Sr. Director of Regulatory & Medical Writing, MMS. “We have been at the forefront of medical writing in the pharmaceutical industry for more than 15 years, and this kind of solution, tailored specifically for the unique needs of highly regulated medical writing documents, will allow us to continue that leadership path and bring fresh solutions to clinical trial sponsors across the globe.”

A 2023 Forbes Advisor survey revealed that 64 percent of businesses expect their productivity to increase with artificial intelligence.

Increase medical writing efficiency and improve quality

This initiative will allow the companies to complete an initial draft of a medical writing document more efficiently. Instead of writing sections from scratch, TrialAssure Link will produce the first draft for the medical writer to review and update. In other words, it will:

  • Reduce the amount of time it takes to produce the first draft
  • Enhance quality, by automatically and appropriately incorporating all the necessary information from source documentation
  • Improve compliance, by introducing reliable and speedy automation

“Our AI solutions experts and SMEs with extensive experience in medical writing and clinical trial-related documents are working together hand-in-hand to develop this new technology that will help shape the future of the pharmaceutical industry,” said Zach Weingarden, Director of Product Solutions, TrialAssure. “The possibilities of AI in this industry are endless, and we are exploring additional use cases that target different aspects of the clinical trial and related documents at various stages.”

For more information or to see a demo of AI capabilities, visit www.trialassure.com/about/contact/

About MMS

MMS Holdings (MMS) is an innovative, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.

For more information, visit www.mmsholdings.com

About TrialAssure

TrialAssure is a leading, global clinical trial disclosure and data transparency provider with unmatched experience in helping navigate complex regulatory compliance challenges. TrialAssure provides fast, affordable, and intelligent software and service solutions to facilitate clinical trial disclosure (registration and results reporting), document and data anonymization, and enhanced patient engagement, while delivering the highest quality clinical trial transparency deliverables that exceed the most stringent requirements. Established in 2009, TrialAssure regularly adapts to ever-changing clinical trial disclosure and data transparency requirements and was named Data Solution of the Year – Healthcare in the Data Breakthrough Awards. 

For more information, visit www.trialassure.com

Media Contacts

MMS: Prasad Babu, Director-Marketing Operations, pbabu@mmsholdings.com

TrialAssure: Don F. McLean, CMO, dmclean@trialassure.com

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