Periodic report compilation is a critical and time consuming activity for Pharmacivigilance department of pharmaceuticals and life science company. Periodic reports like PSUR, PRBER, PADER and so many other requires data and tables from safety database and the same time many more narration and information at the time of compilation.
Manual work to download the required tabular and other reports from safety database, formatting them in the templates in authoring tool and then reviewing and publishing is not only time consuming exercise but also error-prone.
Our automation tool connects template of document management system to relevant data, table and reports of safety database and pulls the data to the document template based on the combination of product, period, report type and other parameters. In the process, report compilation team gets almost ready-made dataset in predefined template to complete the authoring work quickly.
Once created, report document will go through the workflow and final approved report can be published. The reports can also be versioned and achieved for future reference in our document control tool.
Features
- Report compilations are based on templates, and templates can be pre-defined and revised
- Reports can fetch information from Safety database as well as document control system
- Report compilation can also fetch data from any other source system as well
- For region and country specific report writing requirements, the same or different template can be used
- Collaboration and work flow is configurable