Placing medicinal products or other pharmaceutical products on the market involves extensive approval procedures in which the properties, quality, and purity of the product are verified.
Every day, regulatory authorities receive new applications, updates, and modifications of formulations for review – all of which have to be processed expeditiously. In this context, making sound and consistent decisions is mission critical.
Aside from the plethora of different documents, the homogeneity of the submissions also renders verification difficult. Products with similar ingredients, identical active ingredients, or only minimal differences in composition pose challenges for clinical reviewers.
In order to make informed and – most importantly – consistent decisions and to facilitate a more streamlined way of working while simultaneously minimizing the risk of complaints arising from inconsistent decisions, these organizations needed intelligent solutions to support their day-to-day work.
Mindbreeze InSpire enables company-wide and comprehensive provision of information.
This gives clinical reviewers the overview they need quickly. To achieve this, Mindbreeze indexes both the existing internal data (from Documentum, such as action letters, review recommendations, information requests) and the external data (such as eCTD backbone: forms, data from studies, and the like), links it with the structured data from the Oracle database, and supplies this to the reviewers in 360-degree views.
The comprehensive semantics pipeline together with integrated taxonomies, catalogs, and ontologies (for example, integrity mastered data, MedDRA) ensure that the specific content is understood.
After a comprehensive evaluation followed by a successful test phase, in which specialized search applications have already been realized, the complete implementation of the solution in the organization was carried out together with the Mindbreeze team.
Due to the sensitivity of the existing information, the Mindbreeze InSpire appliance was integrated directly into the organization’s own data center (without an external connection) and all relevant data sources were connected using standard connectors.
Mindbreeze InSpire provides clinical reviewers with contextual information, such as forms, studies, and reports, and tailors this to their role, position in the company, and individual authorization.
Additionally, machine learning algorithms provide a personalized ranking of results based on an analysis of user behavior. Furthermore, specific filters (manufacturer, dosage form, ingredient) can be used to search for information even more precisely. This makes it possible to generate customized 360-degree views of a given topic, such as a submission, a specific drug, an active ingredient, or a particular applicant, to compare information efficiently, and to identify any possible correlations.
By using Mindbreeze InSpire, the organization is now able to process the existing data effectively and leverage this data to inform their decisions.
The eCTD search app gives users an auto suggest based on the metric catalogue.
The auto suggest is used to help the user navigate to the most preferred search term using an internationally recognized dictionary.
- More than 6,500 different product categories
- More than 17,000 employees
- Over 20,000 different approved prescription medicines
- Several million indexed documents