The move by BioClinica will add Blueprint’s Compass, a cloud-based site scoring tool, to the BioClinica eClinical platform. The tool will enable pharma companies and CROs (contract research organizations) to embrace the reduced source documentation approach outlined by the FDA in recent guidance. Industry previously told us that the guidance is best for Phase II and IV work.
Compass is used to evaluate potential risks to patient safety and clinical trial operational performance. It assigns a performance-based score to each investigative site based on a combination of quantitative data and qualitative information.
BioClinica President and Chief Executive Officer Mark Weinstein told Outsourcing-Pharma.com at DIA’s 50th annual conference in San Diego: “There’s a lot of conversation in the industry over the last couple of years trying to figure out how to maintain the highest quality of data but reduce the cost of getting that data. A large component of the cost is with monitoring – the whole source data verification -- we became aware of this small group [Blueprint], which can find a way to take the data and risk-adjust to maintain the quality data and reduce the cost.”
“The beauty of this is we can immediately take any study that we’re doing an EDC for, as well as with other EDC options, and we can provide these services,” he added.
President and Co-founder of Blueprint Clinical, Courtney McBean added, regarding the tool, “It’s an intelligent monitoring solution that replaces 100 percent source data verification with greater use of off-site and central monitoring.”
Still, Weinstein cautioned that Blueprint is a young company, which is why BioClinica wanted to get involved early. “If it were a nine inning game, it’s probably in the second inning” for Blueprint, Weinstein said. “If you’re a small player, you have a difficult time of getting interest from big pharma as clients are risk averse from a vendor perspective. Take Blueprint Clinical – they’ve had a lot of interest from big pharma but none of them stepped up. But now that they’re with BioClinica,” big pharma will step up, Weinstein said.
He also predicted that in three to five years risk-based monitoring will become the de facto standard. But he cautioned that there’s still some unknown from clinical research sites. “50% of sites in clinical research projects will never do a second project so there’s a lot of churn on the investigator site. It’s a more difficult business than many people have envisioned,” he said.
BioClinica Developments
With the recent signing of two $30m contract extensions with Big Pharma, BioClinica seems poised for continued growth. Over 40% of BioClinica’s clients buy more than one of its products, Weinstein said, noting that the company has “more active touch points,” or relationships, “than anyone else in this space – we have well over 600 projects with 200 clients every month. Let’s face it, relationships are how it starts.”
And BioClinica isn’t just working with small and medium-sized pharma companies, Weinstein added, noting the company works with all the top 20 pharma companies and over 80% of the top 50. For example, GlaxoSmithKline now uses the company’s IRT (interactive response technology) tool, and Sanofi is now deploying its CTMS (clinical trial management system) tool. Over 60% of business in imaging is with top 20 pharma clients, he said.