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 AWS AI services to accelerate generation of these narratives.

Solution Features: 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 for the medical writer to consider and edit as required to improve the same

Value Proposition:

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