In a highly regulated landscape, a Top 5 Global Pharmaceutical Company faced a daunting scientific communications challenge: meeting the strict new EU Clinical Trials Regulation (EU CTR 536/2014) for Plain Language Summaries (PLS). The manual process to translate technical clinical data for public consumption took approximately four months from start to finish.

By partnering with Sorcero, the Plain Language Summary team implemented the Sorcero Plain Language Trial Summary (PLTS) solution - a medically-tuned AI platform that accelerated the end-to-end production cycle by six weeks. This transformation reduced time-consuming manual quality control (QC) from days to minutes while ensuring absolute scientific integrity and non-promotional compliance.

Bridging the Scientific Gap with Plain Language Summaries

The Plain Language Summary team serves as a vital bridge between complex clinical research and global public transparency. Operating within a major pharmaceutical organization, this team is responsible for distilling clinical study results into reader-friendly formats accessible to trial participants and the general population. Their primary mission is to fulfill transparency commitments by communicating factual, fact-based information that meets stringent health literacy principles across the globe.

Challenges: Regulatory Pressure and Manual Process Bottlenecks

The team faced the EU mandate requiring clinical trial results to be posted publicly in a reader-friendly format. This required distilling complex technical data into summaries accessible to the general public (6th - 8th grade reading level), a task complicated by low global health literacy. Additionally, the team operated under strict non-promotional guardrails, ensuring that documents remained purely fact-based without creating incorrect medical inferences.

Operationally, the team was hindered by a linear, manual workflow that typically required four months to reach a final English version. The most exhaustive stage involved manual quality control, where every statement was verified against original source documents using a metaphorical "magnifying glass" - a task so time-consuming it created a major bottleneck in meeting strict regulatory deadlines.

The Solution: The Sorcero Platform for PLTS

To address these bottlenecks, the team implemented the Sorcero Plain Language Trial Summary (PLTS) solution powered by industry-leading, medically-tuned AI.

• Automated Drafting: The platform automatically ingests source clinical study reports (CSRs), working them into approved templates. By automating initial drafts, the team was able to eliminate the manual outline step entirely.

• The Smart Validator: A dedicated, proprietary QC tool allows the team to run validators in minutes that would otherwise take days to perform manually.

• Compliance Guardrails: The platform includes a proprietary promotional language check that flags specific "buzzwords," allowing users to quickly evaluate context and ensure fact-based delivery.

• Learning Agility: The Sorcero team “demonstrated a deep understanding of the life sciences behind the data”, coupled with a platform that learned from user feedback to mirror the team's preferred voice and logic.

Quantifiable Success: Saving 6 Weeks and Gaining Operational Flexibility

The partnership delivered immediate, quantifiable efficiency gains:

• 35% Timeline Reduction: The end-to-end production process was shortened by at least six weeks (approximately 1.5 months) from the original total timeline of 4 months.

• Enhanced Operational Agility: By shortening the cycle, the team gained significantly more flexibility regarding when to begin the production process relative to strict regulatory deadlines.
  

• "Magnifying Glass" Efficiency: The validation tools replaced manual "magnifying glass" reviews, checking source statements in minutes rather than days.

• Trusted Oversight: The "Human + AI" approach allowed scientific experts to focus on refining and improving content rather than spending entire workflows checking original source documents.

A Recommendation to the Industry

When asked what advice the team would give to peers in the industry who are facing similar regulatory challenges, the Plain Language Summary Lead offered this clear directive:

"If you are still drafting plain language summaries manually, you should take a very close look at this solution. The amount of time saved is incredible... Knowing the flexibility and agility of what Sorcero can produce, I'm sure it could be a benefit to many organizations. It is definitely worth the time and the effort to explore."