Chiltern revamps early-phase clinical division

By Phil Taylor

- Last updated on GMT

Related tags Pharmacology

Contract research organisation Chiltern International has finalised the reorganisation of its early-stage clinical development activities, following its acquisition of Drug Development Solutions in February.

The firm’s two early-phase units have now been merged into a single operation branded as Chiltern Early Phase.

The purchase of DDS brought with it a Phase I clinical trials unit with 42 high intensity care beds located at Ninewells Hospital and Medical School, Dundee - one of the UK's major teaching hospitals. The unit has expertise in first-in-man studies and in systemic drug phototoxicity studies in humans.

It is also one of only a handful​ of Phase I units in the UK that is located within a major hospital that can provide emergency medical services if required, which is a critical consideration in light of the 2006 tragedy in which six patients at a Phase I unit located in Northwick Park hospital suffered catastrophic side effects in a first-in-man trial.

But for the close proximity of emergency care the consequences of that trial could have been much more serious, and for Chiltern the addition of the DDS unit allows it to attain the higher level of voluntary accreditation available for Phase I units from the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

Chiltern’s other Phase I unit is in Slough, just outside of London and houses 30 beds.

Dr Brian Sanderson, medical director of the new Chiltern Early Phase division, said: “We are now looking to build on our units' long histories of good science and medicine, both in the areas where we have traditionally been strong but also in new areas of specialisation such as diabetes and cardiovascular medicine​.”

He also said moves were afoot to forge academic links to provide specialist studies involving new biomarkers.

With the integration of the units now complete, “Chiltern Early Phase can cover all therapeutic areas and all types of clinical pharmacology studies, with specialisation in first time in man, drug photosensitivity, drug-drug interaction, Japanese bridging and vaccine studies​,” said the company in a statement.

The CRO has been in expansive form of late, signing collaborations or opening offices to increase its presence in the fast-growing markets of Asia, Eastern Europe and Latin America.

Related topics Clinical Development Phase I-II

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