Plain Language Documents
Plain Language Summaries: Incorporating the Patient Voice into the Clinical Trial Lifecycle
Making clinical trial results accessible through plain language, from protocol synopsis to final results.
Veristat's plain language documents transform dense clinical data into accessible, patient-friendly content, using proven health literacy principles, customizable templates, and visually engaging design. These documents don't just meet EMA regulatory requirements, they build trust, transparency, and engagement across everyone with a stake in your trial.
Complex clinical trial information doesn't have to stay complex for the people it affects most.
Understanding shouldn't depend on a reader's scientific background. Our plain language documents are built around patient-centric design, prioritizing health literacy and numeracy so patients fully understand a trial's objectives, risks, and benefits, while meeting global regulatory requirements, including Annex V of EU Regulation No. 536/2014.
- Patient-Centric Design. Health literacy and numeracy principles ensure patients fully understand trial objectives, risks, and benefits.
- Regulatory Compliance. Meeting EMA requirements, including Annex V of EU Regulation No. 536/2014, and other global standards.
- Enhanced Visual Appeal. Infographics, white space, and structured layouts make documents engaging and easy to read.
- Accessibility Standards. Choose from your own templates or Veristat's, designed to improve accessibilityfor those with visual impairments or language barriers.
Veristat Expertise
Veristat combines deep regulatory expertise with innovative communication strategy to deliver plain language documents that genuinely resonate with patients and caregivers, not just check a compliance box.
Regulatory Intelligence.
We actively monitor evolving EMA regulations and participate in global working groups to keep every summary current and high-quality.
PLPS for Clinical Trial Applications.
Public Lay Protocol Summaries help lay members of EMA review committees clearly understand clinical trial protocols, supporting informed, meaningful participation in the review process.
Compliance and Clarity.
Meeting global regulatory standards through expert insight and active participation in international working groups.Veristat's Offerings
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Plain Language Protocol Synopsis (PLPS).
Simplifying clinical study protocols into clear, non-technical language for everyone to understand.
Informed Consent Forms (ICF).
Providing the critical information individuals need to make informed choices about participating in research.
Plain Language Summary of Results (PLS).
Making key study insights accessible to everyone, regardless of scientific background.
Regulatory Compliance & Individual Return of Results.
Prioritizing clarity in the return of results to support both compliance and patient understanding.
Meet Our Experts
Laura Sheppard, MBA, MA
Senior Director, Regulatory Services Management
NEXT STEPS
What's Next in the Drug Development Process
Clinical Disclosure & Transparency.
Extend patient-facing transparency into clinical trial posting and disclosure requirements.
Regulatory Submissions Services.
Connect your plain language documents to the broader IND, NDA, BLA, or MAA submission strategy.
Regulatory Publishing.
Get your plain language documents published and submitted through the right regulatory channels.
A patient can't consent to what they can't understand.
From protocol synopsis to plain language results, we build documents that meet regulatory standards and actually reach the people they're written for. Share where your program stands, and one of our plain language experts will follow up.
Frequently Asked Questions
Plain Language Summaries are patient-friendly documents that simplify complex clinical trial data into accessible, easy-to-understand information for patients and the public.
EMA regulations mandate Plain Language Summaries to foster transparency and support public engagement in clinical research.
Veristat's PLS templates meet the requirements of Annex V of EU Regulation No. 536/2014. Veristat can work from a sponsor's own template or its own, both designed to be inclusive and understandable regardless of the reader's scientific background.