The following case study is based on real work conducted between TrialAssure and Daiichi Sankyo to accelerate the development of Plain Language Summaries using TrialAssure LINK AI.
Problem
For global sponsors like Daiichi Sankyo, the creation of Plain Language Summaries (PLS) has traditionally been a time- and resource-intensive process. Each document requires extensive manual drafting by external service providers, multiple lengthy review cycles by several stakeholders, and quality control by internal teams.
This manual approach limits scalability, increases turnaround times, and drives up costs. More importantly, it often creates hesitation around adopting new technologies like AI, as many Sponsors seek solutions that can enhance efficiency without introducing additional risk or compliance concerns.
Solution
TrialAssure partnered with Daiichi Sankyo to deliver end-to-end PLS document creation through its LINK AI software and expert medical writing services. Using a hybrid model that blends AI-powered drafting with a human-in-the-loop validation process, TrialAssure provided Daiichi Sankyo with an approach that was both efficient and compliant.
The workflow included authoring, quality checking, addressing feedback, and delivering approved PLS documents ready for publication. LINK AI’s capabilities allowed for automated first-draft generation, while TrialAssure’s experienced writers further refined the outputs. This reduced the need for extensive internal QC and the operational burden on their team.
Key differentiators of the TrialAssure solution and service model included:
- AI-enabled speed and scale: Up to 80% faster document delivery
- Cost efficiency: 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
Results
The collaboration led to measurable improvements in document creation efficiency and quality. Daiichi Sankyo achieved up to 80 percent faster turnaround times and around a 50 percent reduction in cost per document compared to traditional authoring methods.
Reviewers found the PLSs to be easier to read and better organized, with improved flow and clarity across key sections, such as study objectives, endpoints, and methods. TrialAssure’s human-in-the-loop model ensured accuracy and readability of each PLS delivered.
Following the success of the pilot, Daiichi Sankyo formalized the partnership through a renewed service agreement, with options for expansion and additional services such as translation and accelerated delivery.
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