As part of the expansion, the company has named Terek Peterson as the vice president of clinical analytics and data strategies.
“We want to build awareness about the importance of standards and about the opportunities our customers have to apply them to their advantage,” said Peterson, who will lead the team focused on CDISC data collection and submission standards.
“Any time you need data to make a decision, you have an advantage if data are standardized and analysis-ready,” added Peterson. “Sponsors who commit to standardizing data and invest in early planning can benefit from more than improved efficiency.”
As Peterson told us, standardization also can increase the value of clinical trial libraries, by using retrospective data in metadata analyses and new submissions.
Where it previously took years to get studies ‘in shape’ for CDISC-compliant submissions, Peterson said, now, “these data can be sitting on a shelf, ready to go.”
“The future is about applying standards to YPrime systems so that transfers are automatic, and data are in standard format on demand,” he added.
“When we can build eCOA platforms with standardized data automatically pulled into the study build, we will be able to deliver greater visibility while studies are ongoing. Next, we could connect to wearable sensors and other devices,” said Peterson.
“If sponsors are not preparing for this future now, they won’t be able to take advantage of emerging technologies coming down the road that offer transformative benefits to time, cost and data quality,” he added.
Speaking to its eCOA consulting services, Mark Maietta, president of YPrime, said the company helps customers in various areas.
“Experienced eCOA managers often require consultation on design, planning, and process to ensure implementation consistent with industry best practices and regulatory expectations,” he told us.