TrialAssure® – a leading, global provider advancing clinical trial disclosure, data sharing, and transparency – has announced the release of TrialAssure LINK software for the efficient development, review, translation and publishing of plain language, or lay summaries.
TrialAssure LINK transforms information from existing sources and auto-populates a majority of mandatory sections, generating lay summary language ready for review and editing. TrialAssure LINK will cut more than four weeks out of the process of writing plain language summaries from scratch, allowing Sponsors to meet increasing compliance requirements and simplifying the lay summary generation process.
Key features of LINK include the ability to:
- Create ready-to-review lay summaries through preconfigured data feeds
- Manage workflows by serving as a comprehensive project management solution
- Maximize re-use of clinical trial data, speeding the process and enhancing data integrity
- Adhere to best practices using lay term glossaries, readability analytics, and auto-generated graphics, charts, and images
- Apply and review translations consistent with languages spoken by clinical trial participants
- Meet global transparency demands
“This comes at a time when the new EU Clinical Trial Regulation is set to now require lay summaries for every clinical trial in Europe as of January 2022,” said Mohamad Zahreddine, Chief Information Officer, TrialAssure, and member of the Forbes Technology Council. “The creation of TrialAssure LINK is in direct response to the immense support that Sponsors will need for this historic change in regulation.”
Over 30 countries will require every clinical investigation to include a lay summary of trial methods and results. These summaries have shown to provide great value to investigational sites, clinical trial participants, and caregivers worldwide.
“Plain language summaries enhance trial participants’ access to information, and LINK creates lay summary translations that are linguistically, culturally, and contextually accurate,” said Kelly Vaillant, Senior Director of Global Transparency Strategy and Compliance, TrialAssure. “It is important to us, as well as Sponsors, to increase awareness of ongoing clinical research in the biopharmaceutical and medical device environment. Specifically, an area of focus in the clinical trials space is to improve patient engagement through improved transparency, and LINK supports that.”
TrialAssure LINK is a core application within The Ultimate Transparency Suite™ along with existing applications that include TrialAssure REGISTRY, TrialAssure ANONYMIZE, and TrialAssure BEACON. The company expects to announce additional capabilities and enhancements to this suite of applications later this year, which will further aid transparency activities, compliance, and patient and investigational site engagement.
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 or follow TrialAssure on LinkedIn.