Clinical Trials and Research
Press
Statement
3rd September 2010 |
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Shandon
Clinic has been involved in the conduct
of a clinical trial in 12 healthy male volunteers
involving the drug rimcazole, which was
being developed by Modern Biosciences for
patients with cancer.
Last
Friday, August 27th, three volunteers unexpectedly
developed seizures. They were treated at
Shandon Clinic, but were transferred to
the Cork University Hospital as a precaution.
The other nine volunteers, some of whom
developed mild side-effects, remained in
the clinic under medical supervision. The
clinical trial, which was not due to complete
until Thursday 2nd September, was immediately
terminated.
The
hospitalised volunteers made a rapid recovery
and were discharged from Cork University
Hospital on the morning of Saturday 28th
August. As a precautionary measure, all
12 volunteers remained at Shandon Clinic
under medical supervision until Monday 30th
August when they were discharged.
The incident was reported to the Irish Medicines
Board and the Ethics committee in accordance
with legal requirements, and is now the
subject of an investigation. Shandon Clinic
is cooperating fully with this investigation.
Dr.
Muiris Dowling, Medical Director
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Shandon
Clinic is an independent Clinical Research
Centre (CRO) based in Cork, Ireland. Our
clients can expect a proven and committed
partner supporting their efforts in bringing
innovative products to market. Shandon provides
a breadth of experience, a high degree of
flexibility, and a qualified depth of resources,
positioning the clinic to handle studies
and programs of studies of any size.
After foundation as a clinical pharmacology
unit in 1990, our expertise has grown, as is reflected in the level of service offerings available.

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Our aim is to ensure the safety and efficacy of marketed drugs and help our clients to avoid costly errors that can threaten revenues and reputation. View recently completed and ongoing Bioequivalence and Pharmacokinetics studies.
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