Our client is a privately owned, Swiss company. They are known as a world-class developer of preclinical software, selling their solutions to top pharmaceutical companies all over the world. critical software used within the full spectrum of preclinical science. Their thirty-plus year history of software developed by scientists for scientists is a hallmark that is unmatched in the preclinical space. It is, in fact, why 8 of the Top 10 Pharma companies in the world use our client’s software, as do quality CROs and also smaller pharmaceutical companies, chemical companies, universities and regulatory agencies.
The first challenge of the project was implementing support for reading + writing data in XPT (SAS XPORT) format. XPT represents a data format from SAS (Statistical Analysis Software) that is designed to be compatible with other computer systems; used to export an SAS data set to another platform or software program.
An XPT file is basically a text file whose content respects a rigorous set of rules like: data set records are 80 bytes in length, all character data are stored in ASCII, all integers are stored using IBM-style integer format and all floating-point numbers are stored using the IBM-style double, etc. More information about the XPT format can be found here: http://support.sas.com/techsup/technote/ts140.pdf. Research was necessary, since the XPT format’s documentation is scarce and most of the validation tools usable are not free, or free but not 100% compatible with each other.
Another challenge was building the conceptual models and the implementation for representing clinical study data for electronic data interchange (SDTM = Study Data Tabulation Model for representing clinical studies data, SEND = Standard for Exchange of Non-Clinical Data). The SEND standard is developed by the Clinical Data Interchange Standards Consortium’s (CDISC) SEND Team for non-clinical data collected from animal toxicology studies. SEND is an interchange standard rather than a presentation format; it is assumed that tabulation data will be transformed by software tools to better support viewing and analysis. The FDA has been the leading regulator in encouraging the development of SEND. Extensive research was also necessary (forums, online discussions, online resources), since the standard goes through an extensive process of content development and public review.
Benefits & results
Our SEND solution places now our client in a list of 40 world-wide providers of Clinical Data Interchange Standards solutions.