Principal services include:
Bioequivalencee testing
Pharmacokinetics studies
Renal / hepatic impairment studies
Dermatology (including tolerance & irritancy)
Oral Soft Tissue studies
Out-patient studies


Recently completed and ongoing studies are listed under "NEWS".

In order to cater for the needs of a variety of clients, we are able to provide an A-Z clinical trial service, including:

protocol and case record form development
IRB and Irish Medicines Board submissions
recruitment and screening
clinical phase
data management and statistical analysis
clinical report writing


All studies are subject to in-house quality assurance throughout.

Analysis of plasma samples is generally arranged with one of our associate laboratories. Recent lists of validated methods are available on request.


Bioequivalence

Shandon Clinic offers a first-class, cost-effective service. We believe that the quality of our work, which has been praised by regulators, is at least the equal of that produced by our most able competitors. The clinic enjoys an excellent reputation for scientific honesty in Europe and further afield. We not only allow clients direct access to expert members of staff at all times but also provide a free post-study service to customers should difficulties arise with regulatory bodies worldwide.


Clients ultimately save money by rapid registration of their products using data generated and presented by Shandon Clinic. Our European clients have profited by selling dossiers that include studies from Shandon Clinic on to other companies. Irish law allows for the conduct of experimental studies within the final two years of the patent life of a reference product.

Shandon Clinic has recently expanded. A clinical unit in South Africa now affords us increased capacity, and allows provision of cost-effective service to clients who are on a tight budget. This unit also allows us to take advantage of the less rigid patent laws in that part of the world.


Pharmacokinetics

Our large database of more than 1000 healthy volunteers provides subjects for a variety of pharmacokinetic studies. We also have access to databases of patients with hepatic impairment and renal impairment, and have ready access to elderly volunteers.

The following types of studies are performed at Shandon Clinic:

Relative bioavailability of established and experimental formulations
Single and multiple-dose kinetic studies
Food-effect kinetic studies
Selected interaction studies
Pharmacokinetic analyses of pilot and development batches of medicines
Immediate and modified release formulations
Kinetics in slow and fast metabolisers (genotyped; phenotyped)
OTC and prescription-only drugs
 

We have experience of a variety of delivery systems, including tablets, capsules, solutions and suspensions, transdermal, buccal and rectal applications, formulations designed for delayed release, and also products designed for topical application to various parts of the body. Past studies have involved most therapeutic areas, including anti-infectives, neuropsychiatric agents, non-steroidal anti-inflammatories, antihypertensives, anti-diabetic agents, drugs used in peptic ulcer disease, anti-tussives, antihistamines, corticosteroids, and diuretics, amongst others.


Renal / hepatic impairment

Shandon Clinic now has the capacity to perform selected pharmacokinetic studies in patients with mild-to-moderate hepatic impairment, and in patients with mild, moderate and severe renal impairment. The Cork area has a relatively high incidence of chronic auto-immune hepatitis, and of polycystic disease of the kidney. These, along with other diagnoses, contribute to patient databases that we have developed in collaboration with local specialist consultant physicians. We intend to expand our involvement in this important area of expertise.


Dermatology

Areas of experience include assessment of skin irritation (semi-occlusive or occlusive patch testing) using developmental formulations, and assessment of skin tolerance of consumer healthcare products. Studies in acne have also been performed. We have a large database of healthy volunteers who participate in such studies; many of these have "sensitive" and/or "Type 1" skin.

Oral Soft Tissue

Shandon Clinical has a small, dedicated dental unit, which is run in collaboration with a local academic specialist dental practitioner. Our expertise lies in the assessment of the tolerability (oral soft tissue irritation) of newly formulated toothpastes or other local applications. Our large database of healthy dental volunteers, coupled with the experience of our staff, allow us to complete studies in 50 to 100 subjects in a matter of weeks. Recording of local lesions using digital cameras can be offered.

Dental facilities


Out-patient studies

Historically, we have generally confined ourselves to studies involving clinical problems for which we may attract patient volunteers directly by advertising in the local media. Our excellent reputation in the locality, coupled with "word of mouth" (a vital means of communication in Irish society) allows rapid recruitment of large numbers. Where simpler recruitment methods are inappropriate, we collaborate with local hospital consultants or general practitioners.

Typical studies have involved 30 to 300 patients. We have particular expertise with consumer healthcare products, though we also regularly perform out-patient studies with ethical pharmaceuticals. Conditions that have been studied in recent years include simple coughs and colds, soft-tissue (sports) injuries, osteoarthritis of the knee, mild-to-moderate asthma, haemorrhoids, nappy rash, dandruff (pityriasis capitis) and headlice.

Recently completed and ongoing studies are listed under "NEWS".

 
Home About Services Staff Links NewsContact Us
Design & Copyright Abu : 2001-2003 All rights Reserved