Clinical Data Management
Data structures and how they are gather are as important as the proper data.
Data generated during Clinical Studies are one of the most valuable assets in Pharmaceutical sector. When gathered within a database, multiple steps of data cleaning are required: results units, patient’s harmonization, edit checks, queries and Data Clarification Forms. Once this cleaning process is performed, database can be released to specialists of CDISC/SDTM coding and finally submitted to authorities.
Texelia can help Clinical Data Management teams to develop a compatible database to gather various data sources such as CRF (Paper Case Report Form ) / eCRF (Electronic Case Report Form), clinical laboratory results or bio-markers results from samples into a unique database.
Depending of the size of your company, Texelia offers also customized solutions to ensure compatibility with existing applications and infrastructure. It is better to have a suitable product that meets individual needs instead of investing important amount of resources in a market large-scale system. For instance, a Data Collection Tool or a simple Data Entry Interface for a CRF can be developed using web technology. Web tools can be integrated as well to report data in ways that fit Clinical Operation, Safety and Science needs.
Agile methodology used by Texelia allows progress in multiple short iterations, to focus on delivery and to avoid time loss on non-mandatory features.