The late phase services industry is growing thanks to a new regulatory need for more “real world” data, says ISR Reports.
In its latest study – which noted a six per cent growth in late phase activities over the past year among respondents – analysts said health economics and health outcomes studies in particular are on the up.
CEO Kevin Olson also told us that increased awareness of Phase IV study benefits to support marketing campaigns has given rise to the sector.
He said: “We believe regulators and payer are requiring more and more ‘real-world’ data that typically comes from health economics and health outcomes studies.
“But sponsors are also motivated to conduct Phase IV studies as a means of bolstering a product's marketing claims and label content in order to squeeze every bit of value out of a product they can.”
Boosting chances of selection
Speaking about ISR’s recent Q3 quality benchmarking report regarding Phase IV service providers, Olson added that the selection process for a late phase provider however, is relatively unclear in comparison to that in the early phase contract research organisation (CRO) model.
The analysis – which reviewed 19 of the biggest late phase providers, including BioClinica, Covance, Icon and Quintiles – claimed this is due to the relatively small number of attributes sponsors tend to review when selecting a late phase vendor.
However he said that for the provider, a smaller number of criteria could be a boon. He said: “From a CRO's perspective this makes the selling and messaging process simpler. They need to ensure – at minimum – they demonstrate these things in the selling process to feel comfortable they're hitting the sponsor's hot spots.”
Olson added that the stand-out desire for firms is a strong team of project managers, as well as speed of projects.
He suggested that other providers looking to get ahead should ensure a high standard of both elements.