As part of the drug discovery and enhancement process, Pharmaceutical and Clinical Research organizations need to provide safety narratives for each of the patients that participate in a clinical trial. Today, all patient safety narratives are manually created by medical writers to depict the safety information journey of a patient.

Typically, each narrative can take a medical writer upto 1-2 hours to create with additional time for reviews. Since these narratives are part of a regulatory submission and have stringent timelines, it will be helpful to standardize and automate the manual writing component.

Solution Focus: CitiusTech's Patient Safety Narrative solution helps auto-generate narratives from structured or unstructured data which can be reviewed/edited by the medical writer, flagged for criticality and then submitted to an approver. The solution leverages Azure OpenAI, Cognitive Search services to accelerate generation of these narratives.

Clinical Data Extraction: Extract clinical data from SDTM datasets/EDC data which includes lab, Image, Physical, Vital, Demo, Omics data, Adverse events, Serious adverse events, etc.

Narrative Generation: Generate patient narratives, by summarizing clinical data for each patient which help medical writers for in creating faster, accurate and compliant narrative generations.

Clinical Data for Reference: Enable approvers / reviewers to validate the narrative created by providing clinical data of that patient which helps in quick comparisons and updating narrative if required.

Quality Check: Built-in quality score assigned to each patient safety narrative generated for the medical writer to consider and edit as required to improve the same.

Timely Regulatory Compliance: By bringing in standardization to the documentation and eliminating the manual component of the creation process, healthcare organizations can get their regulatory approvals from FDA within the required timelines.

Improved TAT: With automated generation of the first draft of patient safety narratives, medical writers can achieve within minutes what usually took them a couple of hours to get done.

Increased Accuracy: Since the solution removes dependency on manual narrative creation thereby reducing the number of errors.

Greater Efficiency: Medical writers can focus on reviewing narratives instead of worrying about writing thereby better utilizing their time.