Automation Solution for Data & Medical Writing
safeXchange is a web-based automation solution that helps companies handle following functional areas:
- Patient Narrative generation automation from clinical systems connecting directly to EDC systems or taking SDTM / SAS / Excel data sets as input
- Clinical Study Reports (CSR) automation by collecting information from different sources like protocol, SAP & TLFs summary
- Protocol structuring and authoring following Transcelerate Common Protocol Template (CPT)
- Safety narrative generation automation for pharmacovigilance / drug safety teams
- E2B data exchange between any EDC system and Safety/PV database eliminating paper based SAE reporting and manual reconciliations
Data Mapping and generation of data from several sources is all UI driven in front-end and no programming required. All activities (from planning to QC) will be done within the tool and no need of manual processes like emails etc.
System can pull/push data from/to different sources like EDC, Safety DB, SAS, Excel, CSV, others with standard and customized connectors.
System uses AI (NLP, NLG) and other methods to intuitively help minimize time drastically for Writers so that they can focus on science. It Crawls through safety to get required data points using built-in AI Natural Language Processing (NLP). It uses Natural Language Generation for content creation that resembles human written content compared to general templates. This minimizes rework by authors for sentencing and grammar corrections
Templates can be created and modified and assigned to an organization/study/narrative level. This will be used to generate pre-formatted and editable narratives, which provides flexibility to modify according to the need.
The process of generation, review and QC of narratives can be customized per study or per organization with built-in simpler customizable workflow management.
- Eliminates redundant Paper work. Eliminate or minimize QC.
- Reduces delay in review cycles by having more choices of relevant workflows as per study or project model (if 3rd party or CRO is involved)
- Decrease turnaround time for overall narratives process there by providing direct time and cost savings
- Validation of data against the data sources to ensure quality
- Cloud based, fully validated with very minimal setup