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Medical Affairs and Medical Writing > Collaborative Medical Writing with Generative AI Support Platform- UNITY™dx

Collaborative Medical Writing with Generative AI Support Platform- UNITY™dx

165+

Annual Aggregate Reports

50+

Ongoing Clinical Studies

“UNITY™dx™: AI-Powered Collaborative Medical Writing Platform
Soterius introduces UNITY™dx™, an advanced AI-powered collaborative medical writing platform designed to streamline the creation, review, and submission of essential pharmacovigilance documents. Equipped with pre-configured templates, UNITY™dx™ significantly enhances productivity, consistency, and regulatory compliance for reports including PSURs, ASRs, and PADERs. By automating routine tasks, UNITY™dx™ allows medical writers and clinical experts to focus on strategic analysis and high-quality content generation.

Enhanced Collaboration and Precision
UNITY™dx™ facilitates seamless real-time collaboration among physician-led teams, medical writers, reviewers, and stakeholders. Its pre-configured templates align precisely with regulatory guidelines (ICH E2E, GVP, and regional standards), ensuring that all documents meet rigorous global requirements. The structured workflow and AI-powered consistency checks within UNITY™dx™ minimize errors, significantly enhancing the accuracy and quality of all medical writing outputs.

Regulatory Compliance and Efficient Deadline Management
With integrated calendar management, UNITY™dx™ effectively tracks regulatory deadlines, automates reminders, and ensures timely completion and submission of critical documents. This proactive approach reduces compliance risks and guarantees adherence to global pharmacovigilance reporting standards. By harnessing the power of UNITY™dx™, Soterius ensures consistently accurate, timely, and fully compliant medical writing, elevating the efficiency of your pharmacovigilance operations.”

Comprehensive Safety Reporting: Expertly written safety narratives, aggregate reports, and risk management plans.
Regulatory Submission Excellence: Meticulously prepared clinical and non-clinical documents aligned with FDA and EMA standards.
Medical Affairs Communication: Creation of high-impact publications, abstracts, and educational materials.
Scientific and Compliance Expertise: Global regulatory knowledge ensures accuracy and compliance in all documents.
Tailored, High-Quality Writing: Customized solutions to meet the unique needs of safety, regulatory, and medical affairs teams.