How Daiichi Sankyo Accelerated Plain Language Summary Development with TrialAssure LINK AI

This case study follows Daiichi Sankyo Plain Language Summaries from manual drafting to AI-assisted delivery — based on real work conducted with TrialAssure LINK® AI and expert medical writers.

The challenge

For global sponsors like Daiichi Sankyo, creating Plain Language Summaries (PLS) has traditionally been time- and resource-intensive: extensive manual drafting by external providers, multiple lengthy review cycles across stakeholders, and internal QC. That approach limited scalability, increased turnaround times, and drove up costs — and it often created hesitation around adopting AI, since sponsors want efficiency without adding risk or compliance concerns.

The work is not optional. Under the EU Clinical Trials Regulation, sponsors must provide a summary of results written for laypersons, and the EU’s Good Lay Summary Practice guidance sets out how those documents should be written and reviewed. For a sponsor running trials across multiple regions, that turns Plain Language Summaries into a recurring, deadline-bound deliverable rather than a one-off writing exercise.

The solution

TrialAssure partnered with Daiichi Sankyo to deliver end-to-end PLS creation through TrialAssure LINK® AI software and expert medical writing services. A hybrid model blended AI-powered drafting with a human-in-the-loop validation process — authoring, quality checking, addressing feedback, and delivering approved documents ready for publication. LINK AI generated automated first drafts while TrialAssure’s experienced writers refined the outputs, reducing the internal QC burden on Daiichi Sankyo’s team.

What set the approach apart

• AI-enabled speed and scale — up to 80% faster document delivery.
• Cost efficiency — around 50% lower document creation costs.
• Expert oversight — medical writers manage and validate all AI output.
• Risk mitigation — sponsors benefit from AI without implementing it internally.

The results

Daiichi Sankyo achieved up to 80% faster turnaround and roughly a 50% reduction in cost per document versus traditional authoring. Reviewers found the summaries easier to read and better organized, with improved flow and clarity across key sections such as study objectives, endpoints, and methods — while the human-in-the-loop model ensured the accuracy and readability of every PLS delivered. Following the pilot’s success, Daiichi Sankyo formalized the partnership through a renewed service agreement, with options for expansion and additional services such as translation and accelerated delivery.