BOSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) — Sesen today announced the launch of TrialS, a next generation regulatory translation validation platform designed to help life sciences organizations achieve greater accuracy, consistency, and regulatory alignment across global clinical and labeling submissions.
TrialS introduces a modern approach to regulatory translation by addressing one of the most persistent and costly challenges in the industry: even high quality human translation can fall short when evaluated against formal authority requirements. Regulatory guidelines often specify not only approved terminology but also required section structures, safety statements, and template conventions. When translated content diverges from these expectations, sponsors face repeat authority queries, prolonged review cycles, inconsistent global versions, and increased operational burden.
Built exclusively for organizations that operate in regulated environments, including pharmaceuticals, biotechnology, medical devices, and CROs, TrialS uses intelligent automation and life sciences trained AI to identify regulatory inconsistencies before they reach reviewers. This capability supports teams responsible for clinical operations, regulatory affairs, medical writing, labeling, and safety documentation, where precision and cross market consistency are essential.
Solving Pain Points That Traditional Translation Cannot Fix
Traditional translation workflows focus on linguistic accuracy but do not address deeper compliance issues that influence regulatory outcomes. Many discrepancies arise from structural or terminology variations that fall outside the scope of sentence level translation review. As a result, even well translated content may fail validation checks or conflict with authority mandated templates.
TrialS directly targets the most common sources of regulatory friction, including:
- Divergent translations of ICFs, IBs, SmPCs, and patient materials across global markets, often caused by country specific reviewer expectations or legacy phrasing from previous updates.
- Misalignment with MedDRA, WHO Drug, and authority specific terminology, which must be applied consistently across indications, adverse events, contraindications, and product descriptions.
- Inconsistent section structures, templates, QRD elements, and safety statements, which can cause misalignment between versions or non conformity with EMA and other authority formats.
- Variations introduced during repeated updates across multiyear clinical programs, where subtle changes accumulate and produce discrepancies across regions, indications, or product families.
With TrialS, sponsors and CROs work within a unified validation environment that strengthens regulatory readiness from the moment content is translated. TrialS detects deviations early, provides structured guidance for resolution, and preserves consistency across related documents and markets. This reduces rework, accelerates submission timelines, and improves the quality and reliability of global labeling and clinical documentation.
From Translation to Regulatory Confidence
TrialS sits at the center of a modernized workflow that integrates translation, AI validation, terminology governance, and regulatory alignment. By embedding compliance checks directly into the post translation process, TrialS helps teams move beyond traditional quality control toward a more structured, predictable, and authority aligned review cycle.
Key capabilities include:
- AI driven regulatory checks that compare translated content against Health Authority rules, regulatory templates, and controlled terminology.
- Automated structure mapping that identifies missing, misplaced, or incorrectly formatted QRD elements and section structures.
- Smart terminology alignment with MedDRA, WHO Drug, internal dictionaries, and country specific requirements.
- Labeling harmonization tools that maintain consistency across products, markets, and related document families.
- A real time validation dashboard that consolidates findings, accelerates internal review, and reduces cycles between regulatory and localization teams.
- In context preview of labeling and clinical documents, making it easier for reviewers to evaluate content the way authorities will see it.
- Structured content reuse, supporting organizations with large portfolios or multiple submission sequences across regions.
These capabilities allow sponsors, CROs, and medical device companies to reduce operational overhead, improve submission quality, and support more efficient regulatory communication across global markets.
Purpose Built for Life Sciences
TrialS reflects Sesen’s long standing specialization in life sciences translation, where precision, compliance, and domain expertise are essential. The platform integrates seamlessly with workflows involving IMPDs, SmPCs, PILs, IFUs, clinical trial materials, regulatory dossiers, labeling content, and safety documentation. By combining linguistic expertise with purpose built technology, TrialS supports regulatory expectations across pharmaceuticals, biotechnology, medical devices, and CRO operations.
“Global clinical and labeling submissions require absolute consistency. TrialS is designed to give companies regulatory confidence at scale,” said Carl Yao, VP of AI Innovation and Global Business Strategy at Sesen. “This launch reflects our commitment to building technology that directly solves the problems that matter most to sponsors and CROs.”
Experience TrialS
TrialS is now available for demonstrations during the first phase of rollout. Life sciences organizations can request a demo to see how TrialS improves regulatory accuracy, reduces risk & cycle times, and supports faster global submissions.
Request a demo at: www.sesen.com/trials
Learn More About Sesen Solutions
Explore related services that support global clinical research and regulatory submissions:
About Sesen
Sesen specializes exclusively in life sciences translation, supporting pharmaceutical, biotechnology, medical device, and CRO organizations in communicating with accuracy and confidence across global markets. We combine professional native translators with specialized domain expertise and technology driven workflows that enable clinical research, regulatory submissions, labeling, patient materials, and medical communications in more than 150 languages.
Our solutions include SesenGPT for life sciences translation, TrialS for regulatory validation, and a full suite of localization services designed to accelerate global development while meeting the strict expectations of Health Authorities worldwide.
Media Contact:
Nikki Andrews
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A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9a3f913a-eb6d-43b3-8524-7722d740955b
