Patient narrative writing is a critical component of regulatory submissions, yet traditional approaches often struggle to meet quality, and consistency demands under tight timelines. Certara overcomes these challenges with technology-enabled solutions, ensuring consistent, high-quality narratives while reducing time to completion.
Patient Narrative Writing Services
Your partner in quality safety reporting
Certara delivers expertly crafted patient narratives, leveraging advanced technology and deep expertise to ensure consistency, quality, and efficiency.
Learn more about Patient Narratives
Transforming narrative writing with CoAuthor
Inputs for success:
Clinical data (SDTM/ADaMs datasets)
Supplemental safety data (e.g., CIOMS)
Template mapping and programming (includes a sample review) — capable of using pre-Database lock data
Key benefits:
Faster writing and QC processes
Improved consistency and quality across deliverables
Ability to manage high volumes within expedited timeframes
Independence from Statistical Programming for outputs (PPLs, TLFs)
Unmatched consistency
Our CoAuthor platform ensures uniformity across thousands of narratives, eliminating potential discrepancies.
Rapid turnaround
Efficiently manage high-volume projects with expedited timelines using our technology-driven approach.
Expert-driven solutions
Our seasoned medical writers and quality reviewers deliver narratives aligned with regulatory expectations.
Cost efficiency
Reduce costly delays and mitigate risks with streamlined processes and eliminate unnecessary rework.
Driving innovation in patient narrative writing
Certara combines cutting-edge software with expert teams to redefine patient safety narrative creation.
弊社のソリューションを探索
レギュラトリーサイエンス
Comprehensive regulatory support for biotech and pharma.
初期臨床開発
Optimize early-stage clinical strategies and submissions.
後期臨床開発
Streamline late-stage clinical trial submissions.
Expand your knowledge
全て見るGet in touch with Certara
Our team is here to help you streamline your patient narrative writing process. Whether you need expert guidance, advanced technology, or full-service solutions, Certara is your trusted partner in achieving regulatory success.
Expertise in regulatory submissions and patient narratives
Proven technology-enabled solutions with CoAuthor
Dedicated team of writers and reviewers ensuring quality and compliance
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よくある質問
What is patient narrative writing?
Patient narrative writing involves creating detailed accounts of individual patient experiences during clinical trials to ensure safety reporting compliance.
How does CoAuthor improve the narrative writing process?
CoAuthor leverages advanced mapping and programming tools to deliver consistency and efficiency in narrative creation.
Can Certara handle high-volume narrative projects?
Yes, Certara’s expert team and technology enable us to manage large-scale narrative projects with rapid turnaround times.
