The 65-bed clinic will facilitate patient access and help expedite progression to Proof of Concept (PoC) for pharma and biotech clients. The new clinic, which expects to begin running studies in the second half of 2015, will complement inVentiv’s existing clinical facility in Quebec City, Canada.
“Phase I clinical research continues to become more complex, requiring rapid recruitment of unique patient and special populations,” said Riaz Bandali, President of the Early Stage business unit for inVentiv Health’s Clinical Division. “The location of the clinic - in the US, specifically in Miami - will help provide broad patient access thanks to a large population and diverse demographic. This should enable us to better meet the needs of our clients as they navigate the complex regulatory environment of drug development and approval.”
Bandali told Outsourcing-Pharma.com that since the biotech IPO boom over the last few years, “many of these firms are re-investing a substantial amount in the development of their early stage assets representing an excellent opportunity for inVentiv Health to leverage our relationships in this sector and serve this client base with a new clinical offering in Miami.”
The clinic, located in the University of Miami Life Science and Technology Park, will focus on complex studies including first-in-human phase I, phase I-in-patient and other multifaceted phase I trials such as drug-drug interaction, biosimilar, first-to-file and 505b2 trials.
“With inVentiv Health’s phase II-IV clinical business offerings, and our two bioanalytical laboratories in Princeton and Quebec City, our clients should have the information they need to become smarter earlier in the development process, enabling decisions that may improve the design and impact of their confirmatory studies,” said Bandali.
The decision to open a clinic in the US “was driven by our desire to provide our clients options to support their regulatory and development strategies – the US location complements our Quebec location,” he added, noting that both locations put inVentiv in the position of being able to maximize benefits for clients’ priorities.