The two organizations say they will focus the collaboration on protocol development, trial design, statistical analysis, Clinical Events Committee (CEC)/Data Safety Monitoring Board (DSMB) services, clinical monitoring, data management, product safety, project management and quality assurance.
David Novotny, VP of the Medical Device & Diagnostic Division at Novella, told Outsourcing-Pharma.com, “Trials will be focused within the interventional, medical device, drug and combination product space across the vast treatment paradigm for cardiology and vascular interventions. The exact number of trials and opportunities remains undefined, however, noting our current position in the market and field of cardiology, we expect our visibility and support to our customers and patients to increase incrementally.”
Key Factors for Growth
Novella and CRF are currently involved in a number of joint global cardiovascular device studies, the companies said, though they did not note any specifics. These types of trials come with certain influencing factors that can shift the trial landscape.
“With the increased demand of emerging markets like Latin America, Asia and eastern Europe we expect to see continued growth in the cardiology sector complementing the longstanding base of development in the US,” Novotny told us. “Several key factors will influence this trend. The first being patient care requirements and the changing regulations in how cardiology devices are regulated for use and approved for the market. DeNovo and enhanced technologies are requiring relevant clinical data and focus on long-term safety data in real-world settings and health economic data to support market access across the globe.”
In addition, cardiology trial customers in the past “have been relegated to multiple outsourced partners as there was a significant gap in the industry for them to find that one scientific and operational delivery model,” he added. “Our combined intent was, and is, to forge a strategic alliance and delivery option in this space allowing for reduced costs for outsourcing while combining best-in-class knowledge and experience for our customers.”
He also said the goal of the partnership is to further decrease development time while offering scientific, medical and operational support services.
“We expect, over time, to build a delivery model together where sponsors are viewing trial progress in one portal, under one project manager and therefore providing seamless delivery across joint services,” Novotny added.