Narratives are an essential part of any programs’ story, but often become cumbersome due to the many challenges of narrative writing. A large narrative project is typically divided into several stages, within which each individual function typically works within a certain pre-defined budget, set of tasks, and labor allocation silo:
- The biostatistics group produces Tables, Figures, and Listings (TFLs) and patient profiles
- The regulatory writing group authors narratives
- Safety physicians provide clinical review
- Publishing creates the final package
Extra efforts within each step in isolation do not typically create significant overall time advances and often result in perpetuating systemic inefficiencies.
The clinical review step can be used as the example with most negative financial and timeline impact. Typically, safety groups hire a team of temporary physicians to support large projects. Alignment suffers, as the study safety physician struggles to fulfill study-related responsibilities and oversee/align a group of physicians who are frequently new to narrative review. Divergent review comments in turn lead to cycling with regulatory writing, leading to increasing costs.
Another example, is the generation of the clinical database outputs. Biostatistics/programming functions typically subcontracts programmers of tables, figures, and listings for clinical study reports, then program patient profiles. There is little bandwidth for error correction or additions to patient profiles, as typically activities swiftly move on to submission support once that milestone is delivered. In our experience, in approximately 60% of projects, narrative authors and QC personnel find errors in patient profiles. When such omissions are found, 80% of the time, authors are asked to resort to listings to fill in this information at a much greater labor cost than that of a programmatic re-run.
Due to the many challenges of narrative writing, you may find yourself:
- Finding issues maintaining narrative consistency across your studies and programs
- Waiting for final patient profiles
- Having to manually access and input information from CIOMS/safety database data
- Struggling to meet regulatory deadlines
Synchrogenix offers solutions to the many challenges of narrative writing. Synchrogenix creates a centralized, truly cross-functional patient narrative authoring paradigm. Through the use of our Artificial Intelligence technology platform, we can generate 80% of a first draft using the raw data, eliminating the pre-requisite of patient profile programming.
Most other solutions can only process the clinical database data and many require a significant amount of configuration at the beginning of each Study.
Uniquely, Synchrogenix’s AI solution can process Clinical and safety database data with little or no configuration
A recent use case has seen Synchrogenix generate 730 narratives with full QC and finalization in less than 5 business days.
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