Clinical Data Transparency Initiative objectives. The initiative entailed authoring assets that provide redaction, anonymization, and lay summary distribution guidance trialassure clinical trial disclosure protocol registration summaries results registries publish software services vendor consultant trialassure

Managed Services

When needed, our expert disclosure and transparency specialists are available to summarize your study data for registry submission, working with your clinical and transparency teams to ensure accuracy and compliance. We will also facilitate review cycles, quality control checks, final approval, registry submission, and respond to queries from governing bodies. Experts are available to support in all areas of transparency on a global level.

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Enterprise Solutions

Disclosure Workflow Leads assess all planned, ongoing, and completed studies within your pipeline for compliance with global disclosure laws. Expert Disclosure Summary Writers summarize study data for protocol registration and results disclosure to ClinicalTrials.gov, EudraCT, and all other applicable global registries. Throughout the process, the Workflow Lead facilitates study team review, quality control checks, approval processes, registry submissions, and responds to queries from governing bodies. Solutions are complemented through the use of the TrialAssure™ transparency suite to monitor all studies and disclosure activities, ensuring global regulatory compliance throughout your pipeline.

Software Licensing

License TrialAssure™, a comprehensive transparency management system, to manage your study pipeline. Available in a software-as-a-service model with flexible pricing options, and hosted in the Windows Azure cloud for best-in-class security, performance, and reliability. We provide implementation support to get you up and running, including systems integration, data migration, and customized role-based training. As an ongoing partner, we’re available with responsive help desk support as well as a services team that can augment your internal staff and where necessary provide expert consulting.

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