inVentiv builds REMS capacity with ParagonRx

By Gareth Macdonald

- Last updated on GMT

Related tags: Food and drug administration, Pharmacology

inVentiv Health claims the acquisition of ParagonRx positions it as the leading supplier of REMS services in the pharmaceutical contract services sector.

New Jersey, US-based inVentiv said the ParagonRx acquisition, financial terms of which were not disclosed, expands the range of risk evaluation and mitigation strategy (REMS) consulting services offered by its clinical division.

The deal builds on the REMS expansion that inVentiv began in August​ last year and, according to CEO Blane Walter, enables the firm to “deliver a truly comprehensive REMS and risk mitigation services​.”

Walter explained that [ParagonRx’ experience in consultative REMS and safety services is an ideal addition to inVentiv’s offering and added that the combination will offer clients a risk management solution with a single point of contact.

inVentiv also predicted that pharmaceutical industry demand for risk management consultation will grow as regulators on both sides of the Atlantic continue to place an increased emphasis on drug safety.

This idea is supported by data published on the US Food and Drug Administration’s (FDA) website which shows that the agency OKed 68 REMS last year, nearly three times the amount cleared in 2008.

Growing demand for REMS

inVentiv is not the only firm to predict greater regulatory use of REMS, and therefore greater pharmaceutical industry demand for consulting services, in the future.

Late last year for example, Cincinnati-based CTI Clinical Trial and Consulting Services (CTI) set up a dedicated biostatistics, outcomes research and consulting office in Raleigh, North Carolina to meet greater REMS demand.

At the time, company president Lynn Fallon explained that: “With CTI’s focus on the critically ill patient population we are seeing an increasing number of FDA​ mandated REMS​ programmes from our sponsors.

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