Certara’s Plain Language documents are carefully crafted to transform complex clinical trial information into accessible, patient-friendly documents. By incorporating proven health literacy principles, customizable templates, and visually engaging designs, these documents empower patients to make informed decisions about participating in clinical trials. Our Lay Documents not only meet EMA regulations but also foster trust, transparency, and engagement across stakeholders.
Plain Language Documents
Incorporating the patient voice into clinical trials lifecycle
Learn more about Plain Language Documents
Making clinical trials results accessible
through Plain Language
Patient-centric design
Our lay documents prioritize health literacy and numeracy, ensuring patients fully understand trial objectives, risks, and benefits.
Regulatory compliance
We meet all EMA regulatory requirements, including Annex V of EU Regulation No 536/2014, ensuring global compliance.
Enhanced visual appeal
Infographics, white space, and structured layouts make our documents engaging and easy to read.
Accessibility standards
Choose from our sponsor’s templates or Certara’s, which are built to break barriers and support those with visual impairments and language barriers.
Certara’s expertise in Plain Language Documents
Certara combines deep regulatory expertise with innovative communication strategies to deliver Plain Language Documents that resonate with patients and caregivers alike.
Our offerings
Plain Language Protocol Synopsis (PLPS)
Simplifying clinical study protocols into clear, non-technical language for everyone to understand.
Informed Consent Forms (ICF)
Providing critical information to empower individuals to make informed choices about medical treatments or research participation.
Plain Language Summary of Results (PLS)
Making key study insights accessible to everyone, regardless of their scientific background.
Regulatory Compliance & Individual Return of Results
Prioritizing clarity in the return of results to support both compliance and patient understanding.
Meet our expert
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Experts
Laura Sheppard, MBA, MA
Senior Director, Regulatory Services Management
Laura brings 20 years of experience in regulatory strategy, medical writing, and global submissions for both biologics and small molecules.
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Are you ready to enhance your clinical trial communication with Certara’s Plain Language Documents? Our team of experts is here to guide you through every step, ensuring compliance and patient engagement.
Proven expertise in regulatory compliance
Customizable templates tailored to your needs
Innovative designs for maximum patient impact
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FAQs
What are Plain Language Summaries?
Plain Language Summaries (PLS) are patient-friendly documents that simplify complex clinical trial data into accessible, easy-to-understand information.
Why are PLS required?
The EMA regulations mandate PLS to foster transparency and ensure public engagement in clinical research.
How does Certara ensure compliance?
Certara’s PLS templates meet all requirements under Annex V of EU Regulation No 536/2014, ensuring global regulatory compliance. Certara can use the sponsor’s template or its own, which are designed to be inclusive and understandable to patients regardless of their scientific background.
