Jubilant’s primary business is in contract manufacturing, but it also has a US CRO subsidiary called Clinsys Clinical Research, and it intends to offer the TrialStat offering via this business unit.
The Indian firm has joined a fairly select group of CROs which have elected to offer their own eClinical technology rather than partner with a specialist firm. Others include Parexel, which recently bolstered its in-house technology by buying ClinPhone.
Like Parexel, Clinsys will use the EDC system for its own trials but will also make it available to third-parties, including other CROs.
The Indian firm paid CAD 750,000 (€466,000) for Ottawa-based TrialStat CA, and says it was attracted by the fact that the entire package is web-based so does not require any installation on customer servers. It also said the interface was very elegant and easy to use, and that would be a competitive advantage against rival systems.
“TrialStat CA is the industry's first EDC platform to allow all aspects of a study to be configured, deployed and managed through a browser interface, enabling customers to start their studies quickly and cost-effectively,” said Jubilant in a statement.
Clinsys has been eyeing up opportunities in the eClinical space for some time. Earlier this year the company entered into an agreement with Medidata to get non-exclusive access to its Rave technology for capturing, managing and reporting clinical data delivery in multiple mid-to-large Phase II and III trials.
At the time, Clinsys said it was important for CROs to offer a number of data collection choices to patients as “clients prefer custom solutions rather than a ‘one-type-fits-all approach.”
TrialStat has been investing a lot of resources in updating the functionality CA, which is currently in version 4.0. The latest variant allows data from multiple study sources within a project to be evaluated and displayed in simple, graphical representations that can help identify trends and anomalies in the data.
It also removes the need for trial sponsors to export data into another format, such as SAS or Oracle, and users can set up rules to automate many of the repetitive processes and pick up potentially important events, such as a test value that could indicate an adverse reaction to a drug.