CANTON, Mich. – (BUSINESS WIRE) –#iotech–TrialAssure® – a leading global provider of clinical trial disclosure, data sharing and transparency – has announced the release of TrialAssure LINK software for the efficient development, review, translation and publication of plain language or lay abstracts.
TrialAssure LINK converts information from existing sources and automatically fills in most of the mandatory sections to generate layperson summary language ready for review and editing. TrialAssure LINK will fundamentally shorten the process of creating summaries in plain language by more than four weeks, allowing sponsors to meet the increasing compliance requirements and simplify the process of creating layperson summaries.
The main functions of LINK include the following functions:
Create review-ready layperson summaries with pre-configured data feeds
Manage workflows by serving as a comprehensive project management solution
Maximize clinical trial data reuse, accelerate the process, and improve data integrity
Follow best practices with lay glossaries, readability studies, and auto-generated graphics, charts, and images
Apply and review translations that correspond to the languages spoken by clinical trial participants
Meet global transparency requirements
“This comes at a time when the new EU clinical trial regulation will require lay summaries for every clinical trial in Europe from January 2022,” said Mohamad Zahreddine, chief information officer, TrialAssure and member of the Forbes Technology Council. “The creation of TrialAssure LINK is a direct response to the immense support sponsors need for this historic change in regulation.”
In over 30 countries, every clinical trial must contain a layperson’s summary of the study methods and results. These summaries have been found to be of great value to trial sites, clinical trial participants, and caregivers worldwide.
“Plain language summaries improve study participants’ access to information, and LINK produces layperson summary translations that are linguistically, culturally and contextually correct,” said Kelly Vaillant, senior director of Global Transparency Strategy and Compliance, TrialAssure. “It is important to us and our sponsors to raise awareness of ongoing clinical research in the biopharmaceutical and medical technology environment. In clinical trials in particular, the focus is on improving patient engagement through improved transparency, and LINK supports this. ”
TrialAssure LINK is a core application within the Ultimate Transparency Suite ™, along with existing applications such as TrialAssure REGISTRY, TrialAssure ANONYMIZE and TrialAssure BEACON. The company expects to announce additional features and enhancements to this suite of applications later this year that will further support transparency activities, compliance, and patient and trial center engagement.
TrialAssure is a leading global provider of clinical trial disclosure and data transparency with unmatched experience in solving complex regulatory compliance challenges. TrialAssure offers fast, affordable and intelligent software and service solutions to facilitate the disclosure of clinical studies (registration and result reporting), the anonymization of documents and data, and improved patient involvement, while at the same time delivering the highest quality of clinical study transparency, the most stringent Exceeds requirements. TrialAssure was founded in 2009 and regularly adapts to the constantly changing requirements for the disclosure of clinical studies and data transparency and was named Data Solution of the Year – Healthcare at the Data Breakthrough Awards. For more information visit: www.trialasure.com or follow TrialAssure on LinkedIn.
Don F. McLean, MBA