Patient Safety Narratives Services
Precise, compliant narratives to support Clinical Study Reports.
Patient Safety Narratives clearly document clinical outcomes within your Clinical Study Report (CSR). At QInscribe, our expert regulatory writers specialise in creating accurate, concise, and fully compliant Patient Safety Narratives that meet global regulatory expectations and enhance the credibility of your clinical data submissions.
Our approach utilises clinical programming knowledge to automate the creation of narratives. This time efficient approach allows our regulatory writers to handle large volumes of narrative writing. We ensure that process capitalises consistency, clarity, and precision, effectively supporting regulatory review and minimising the potential for queries or delays.
How We Can Help
No matter what your Patient Safety Narrative needs, we can help. Our automated approach can help you craft your narratives with confidence and at scale.
- Individual Patient Narratives
Clear, accurate descriptions of clinical events for patients experiencing serious adverse events (SAEs), deaths, other significant medical events or for all other events eligible per narrative writing criteria defined for the study. - Consistency and Compliance
Ensure consistent data presentation across all narratives using study-specific templates and conventions. Maintain rigorous adherence to ICH guidelines, FDA, EMA, and other global regulatory standards to support compliance and submission readiness. - Strategic Narrative Writing
Expertly integrate patient-level data into concise, medically accurate, and clearly structured safety narratives that enhance understanding and facilitate regulatory reviewer acceptance. Our sophisticated automated approach still allows for uniqueness across each narrative and ensures it presents a coherent clinical story aligned with regulatory expectations and study objectives. - Quality Control & Scientific Review
A scientific peer review of the CSR narratives is conducted to evaluate the logical flow and clinical relevance of the event descriptions. This review ensures the accurate and coherent presentation of clinical signs, symptoms, diagnoses, and related adverse events, confirming that the narratives are medically sound and aligned with regulatory expectations. A dedicated standalone QC process is also implemented to verify that each clinical safety narrative accurately reflects the source data and maintains consistency across all clinical trial documentation. This rigorous QC step helps identify and resolve discrepancies, resulting in high-quality, submission-ready deliverables. - Scalable Narrative Creation
We offer flexible and scalable capacity to support clinical projects of all sizes, from small, targeted studies to large, global clinical trials with thousands of patients. Our automation tools and regulatory writing team is equipped to deliver anywhere from 10 to over 100,000 clinical safety narratives per study, adapting seamlessly to varying project demands. This ensures timely, high-quality outputs across a wide range of therapeutic areas and study complexities.
DBL Narrative Writing for Large-Scale Studies
For large clinical studies requiring high volumes of safety narratives, we implement a strategic pre- and post-Database Lock (DBL) narrative writing model to meet critical Clinical Study Report (CSR) timelines without compromising quality.
- Pre-DBL Narrative Writing:
Our team initiates narrative drafting prior to DBL using periodically cleaned and reconciled data. This proactive approach allows us to complete a significant portion of the narratives, often covering the majority of serious adverse events (SAEs) and adverse events of special interest (AESIs), well in advance of database lock. Narratives are updated post-DBL only if new or revised data becomes available.
- Post-DBL Narrative Finalization:
Following DBL, we conduct rapid data validation and finalisation of the remaining narratives or those requiring updates. Close coordination with clinical data management and medical review teams ensures alignment with final listings and facilitates smooth integration into the CSR.
What You Gain by Partnering with QInscribe
Confidence in Regulatory Submissions
Well-crafted narratives facilitate smoother, more efficient regulatory assessments and reduce agency queries.
Faster Turnaround Without Compromise
Using automation in the creation of narratives means that large volumes can be produced at scale in record time, resulting in cost savings.
Less Administrative Burden
Properly constructed narratives reduce ambiguities and minimise the likelihood of regulatory delays or follow-up requests.
Clear, Persuasive Communication
Clearly documented narratives ensure patient safety events and key clinical findings are accurately and transparently presented.
Consistently High Quality
Detailed narratives reinforce the integrity and credibility of your clinical trial data, supporting regulatory submissions and publications.
Let’s simplify your path to submission.
Talk to us about your upcoming Patient Safety Narrative needs and how we can reduce pressure on your internal team, while keeping your trial timelines on track.