TrialAssure, a clinical trial transparency tools provider, has released a new clinical trial registration and disclosure reporting application, REGISTRY 2.5.
Users will be able to manage the complete disclosure process, including registry evaluations, validation and quality checks, review cycles, approvals and comments from regulatory authorities.
The solution features customisable workflow engine and better tracking of changes in global registries.
TrialAssure REGISTRY 2.5 is designed to auto-calculate workflow steps depending on the progress of a clinical trial. If a step is completed early or late, the application amends the remaining deadlines accordingly.
In case a user gets off-track, the application’s new delinquency finding capability notifies regarding the study progress and approaching deadlines.
In addition, REGISTRY 2.5 allows building of multiple workflow steps personalised to specific needs of business units, products or individual studies.
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Users can use the application’s customisable templates to generate a workflow that facilitates adjustments throughout a study. The application further includes improved registry integrations and validation rules.
TrialAssure product solutions manager Zach Weingarden said: “REGISTRY 2.5 is the perfect choice for all sponsors who are looking for a seamless, defined process for registering clinical trials and publishing results.
“We carefully evaluate all sponsor feedback, and we are excited to give the pharmaceutical industry an even stronger transparency application that works best for them.”
In February this year, TrialAssure introduced a software-as-a-service (SaaS) application called ANONYMIZE DS for automatic anonymization of clinical trial datasets.
ANONYMIZE DS anonymizes original data using customisable techniques. It also assigns a risk score for re-identification of this data based on thresholds defined by the sponsor.