A health IT company that has built a business from digitizing the process of setting up clinical trials and getting them underway plans to use a recent fundraise to speed up other aspects of clinical trials, including patient recruitment.
In a phone interview with goBalto CEO Sujay Jadhav, he explained that the company has automated what has historically been a paper-based process. One of the factors that can influence drug development costs is the duration of clinical trials. Setting up clinical trials and patient recruitment tend to be the most time-consuming part of these trials.
The clinical trial setup time can take up to 18 months, according to the company. One of the things that complicates the process is that each contract research organization or pharmaceutical company has its own approach for setting up these trials particularly in picking sites, sorting out and organizing the relevant regulatory documents. Like other health IT companies set on making drug development more efficient, it has developed standardized processes to make the piles of paperwork involved in these trials more manageable. Through its cloud-based platform, it makes it easier to ensure that the pharmaceutical companies that sponsor the trials, CROs and site teams have the same information — particularly the trial data.
In the latest update in its clinical trial setup platform called Activate, it added the ability to manage expired documents. It also provides alerts for opportunities to track activities and milestones. It also expanded the automated workflows behind its trial documentation process, through integration with an electronic trial Master File.
Jadhev said that one way it may refine its patient recruitment process is by doing a deeper analytical dive of data from previous trials. It may conclude that there were 10 sites from where 90 percent of patients were recruited. “In the future, we may focus on those sites because we can get them set up faster.”
Jadhav said it has seen an uptick in business supporting mid to late stage clinical trials. Its standardized workflow has also been adapted for 55 countries with the goal of reducing variability. Given that Phase 2 and Phase 3 clinical trials may occur at several sites in many countries simultaneously, it also guides teams at each of the trial sites to ensure consistency. Improving workflows in these trials is the kind of low hanging fruit that has helped it boost business with Big Pharma companies — the company claims to work with more than half of them.
In January the company picked up $12 million in funding from Mitsui Global Investment and Dolby Family Ventures, amounting to $37.6 million raised in five rounds since goBalto started in 2008.
