Collating the tools needed for the whole Phase I process, from patient recruitment through to laboratory sample processing, into a package, called TrialOne, is intended to streamline the complex workflows associated with this stage of development.
In particular, having a unified platform with a centralised database improves the sharing of information between different aspects of the trial, Randy Smith, chief technical officer at OmniComm, told Outsourcing-Pharma.
Smith explained that having a centralised database has numerous benefits. For example, it helps keep track of information on potential trial participants and this makes TrialOne “a very efficient way to find high quality patients”, according to Smith.
Another feature of the TrialOne system is proactive data collection. Devices can be connected to TrialOne to feed data directly into the system. Furthermore, the system can remind users when a task, such as taking a sample, needs to occur.
Sponsors will also benefit from the system, added Smith. The web-based system allows sponsors to perform interim data analysis when necessary and monitor the trial to ensure it is being conducted in accordance with the protocol.
The complete, updated TrialOne package is due to be introduced to two clinics in the coming weeks and the screening and recruitment module is already in use at a big, Switzerland-based pharma, according to Smith.
Integration
Other eClinical companies are yet to make dedicated comprehensive Phase I packages because of the difficulty involved, according to Smith. OmniComm gained a head start by acquiring Logos Technologies, a Phase I specialist, and using its own expertise to improve the product.
Later in the year OmniComm will use OmniConnect to integrate TrialOne with TrialMaster, the company’s late stage electronic data capture (EDC) system, and an integrated pharmacy module.
Smith commented that some of OmniComm’s competitors have impressive individual products but integration between them is poor and this can have a detrimental effect on efficiencies and workflows.
In contrast, OmniComm is aiming for seamless integration of its tools, from Phase I through to Phase IV. Smith believes there is demand for this and is driving OmniComm in this direction.