Preclinical software has automatic validation

H+T has completed work on the Japanese language version of its new Clinical Pathology Subsystem.

Sales of the product began this October, and work on the English language version is set to begin shortly.

Products from the Tox-Launcher series provide a secure environment in which test information from preclinical pharmaceutical safety trials can be stored and managed.

The Clinical Pathology Subsystem specifically handles information from blood, urine and biochemistry tests performed during this phase of development.

A number of former laboratory scientists were involved in the development of the Clinical Pathology Subsystem, resulting in a system that takes into account the actual conditions faced by the typical researcher.

As an example, there exist many different devices capable of performing blood, urine and biochemistry tests, and to accommodate the preferences of the researcher, the Clinical Pathology Subsystem has been endowed with the ability to interface with a large number of these devices.

Additionally, information from these devices can be imported at the user's discretion, either in real-time or at the end of a particular batch of tests.

Along with the other subsystems from the Tox-Launcher series, the Clinical Pathology Subsystem offers a number of advantages as compared to conventional pharmaceutical support systems.

One of the main advantages is that the Tox-Launcher system environment, as well as each individual subsystem, is sold as packaged software, allowing for a quick and clean installation of the entire system.

However, due to the fact that all Tox-Launcher software can be broken down into function specific modules, the customer is able to select only the particular components necessary for his or her study.

Essentially, this provides the customer with a tailor-made system without either the cost or the hassle that would normally accompany such a system.

Additionally, each subsystem has been designed with the ability to meet both good laboratory practice (GLP) and FDA Part 11 (electronic records/electronic signatures) regulations, while also allowing for flexibility in the administration of these trials.

This is in contrast to conventional systems, which offer compliance, but only at the cost of a rigid design that ignores the realities of testing and prohibits the entry of any unscheduled information.

The Tox-Launcher series offers both flexibility and compliance, allowing researchers to put forth all information relevant to the trial, while still meeting the standards set forth by the FDA and GLP guidelines.

Every module in each Tox-Launcher subsystem is also equipped with the ability to coordinate with H+T's Auto-Validation software, which automatically performs operational qualification (OQ) validation as laid out in GLP regulations.

This provides a significant advantage relative to conventional systems, which require up to several months for OQ testing to be carried out manually.

Auto-Validation, therefore, allows the user to add or exchange any hardware or software easily and without fear of delaying the trial.

Thus, researchers no longer have to postpone OS updates, or avoid the installation of useful software/hardware on computers managing the trial.

The Clinical Pathology Subsystem possesses all of the features mentioned above, and can be used to improve efficiency and lower cost for all groups administering preclinical pharmaceutical tests.

From large pharmaceutical corporations to independent testing facilities and university research groups, the Clinical Pathology Subsystem, along with the rest of the Tox-Launcher series, provides a viable solution for strengthening the drug development process.

Prices for the Clinical Pathology System begin at US$25,500 for non-GLP compliant systems, and $127,500 for GLP compliance.

Depending on the number of modules selected, the prices for these two systems can increase to $85,000 and $297,500, respectively.