Corporate
IPS Therapeutique is a key international provider of specialised pre-clinical services concerning the cardiovascular safety of new drugs. IPST was concerned with establishing GLP best practices to conform to FDA and OECD requirements in the generation of a number of new regulatory documents. SOLABS was engaged to provide the infrastructure and support to make this possible in a paperless and error-free automated environment.
The need for additional pre-clinical cardiovascular safety data is a new phenomenon. Traditional methods of collecting the data have involved the use of non-compliant experimental software. Validated documentation systems were mostly paper-based. This did not lend itself easily to repetitive work structures. IPST, in collaboration with SOLABS, has been instrumental in building an innovative new approach to validated electronic control of this process.
IPST needed to integrate its study-monitoring platform with several other contributors, working within their study planning system. The performance of this activity more quickly and more cost effectively than other laboratories is a key competitive advantage. In addition, the ability to share information remotely (i.e. through a secure web portal) would optimize the distribution of the test results. At the same time IPST aimed to cut operating costs through eliminating paper.
The SOLABS GLP platform provided a flexibility of design that truly complied with 21 CFR Part 11 requirements. It could integrate and interlink documents from many different sites to build complete and secure regulatory dossiers. SOLABS GLP was installed and the SOLABS team created, and validated, an automated data transfer solution for IPST’s experimental setups and database. This also included the training of their scientists.
The implementation of the SOLABS GLP solution achieved the following results:
- 50% reduction in man hours required to design the studies
- 25% reduction in data analysis time
- 75% reduction in the cost of auditing and test reporting
This optimization of scientists’ time meant that they were spending more time doing the tests and less time handling data and doing administrative duties. The effect on IPST’s culture has been dramatic. All documents are now electronic. Documents are automatically and immediately integrated within the study filing system. All documents are protected, approved, traceable, internally and externally auditable and subject to timely update.
IPST believes that, as a direct result of this activity, they are able to gain competitive advantage not only from a reduction in average lower study costs (typically 25%) but also better study design because they can concentrate on their core competencies – the science! Lead times are also shorter allowing clients to hasten their speed to market.