Irish Clinical Research Centre
Clinical Research Clinical Trials Clinical Pharmacology

Clinical Trials and Research

Press Statement
3rd September 2010

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.

Clinical Research

Principal services include:
Bioequivalence testing
Pharmacokinetics studies
Out-patient studies (Phase II - IV)
Other Services
   

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.

Working within a global market our highly qualified staff consists of a truly international blend of Irish, South African, American and Australian clinical scientists, several of whom have worked at Shandon Clinic since its inception. Our physicians, registered nurses, technicians and quality assurance personnel have many years experience in the conduct of clinical trials to GCP in accordance with ICH, European and FDA guidelines.

We are aware that the "personal touch" provided at Shandon Clinic is appreciated by our clients, testimony to the overwhelming majority of whom place further work with us. Our high personnel retention rate also provides consistency to the smooth running of studies.

Contact Details

Shandon Clinic Group Tel: (353) 21 4505933
9 John Redmond St. Fax: (353) 21 4505894
Cork E-mail:
IRELAND E-mail:
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