The US Food and Drug Administration (FDA) will increasingly require companies to submit a Risk Evaluation and Mitigation Strategy (REMS), according to inVentiv. Consequently it believes there will be rising demand for services that help compile a successful REMS submission.
inVentiv believes it is well placed to provide drug companies with REMS because it already offers risk management services for prescription drugs that have significant risks, such as opioids.
By drawing on this existing knowledge inVentiv will offer a customisable suite of services, covering safety and pharmacovigilance initiatives, patient registries and database development and management.
Terry Herring, chief operating officer of inVentiv, emphasised that “there is no cookie-cutter approach to REMS” and that inVentiv will tailor the services it uses to each drug.
A client’s programme will be coordinated by a single inVentiv representative who will help select the necessary services based on the safety profile of the drug.
Operating income falls 11%
inVentiv’s operating income fell by 11 per cent to $24.8m (€17.4m) in financial results published earlier this month as declining revenues, especially for its communications business, affected its profitability.
Revenues generated by inVentiv Communications, which is the company’s second largest division, dropped by 21 per cent to $75.2m. Despite this inVentiv reported clients’ advertising and promotional spending is returning to normal and new contracts had been won.
inVentiv Clinical also reported a decline in revenues, falling two per cent to $53.3m, because of lower demand for permanent placement and contract staffing. However, the contract research organisation (CRO) related services continued to grow.
The falling revenues in these businesses eradicated the small gains made by the commercial business and the 17 per cent rise in revenues from inVentiv Patient Outcomes.