Non-GLP Pre-clinical Rabbit Study for Post-Trabeculectomy Care

Tender description

Description: Non-GLP Pre-clinical Rabbit Study for Post-Trabeculectomy Care Product Requirements: We require the services of a Clinical Research Organisation (CRO) that is specialised in ophthalmic studies using rabbits as the model animal. Facilities should be compliant with Directive 2010/63/EU (the Directive) and SI No. 543 of 2012, as amended (hereafter referred to as the Regulations) such that studies are conducted in an ethical and compliant manner. The CRO should be capable of ensuring ethical approval from the relevant regulatory agency (with input from the sponsor). The CRO should be capable of procuring the necessary age, weight and sex of desired animals (ie. Rabbits) for the study as well as suitable housing. Estimated capacity required will be 42-50 animals. The CRO should be capable of providing all necessary equipment for a surgery under general anaesthesia. Including, but not limited to, instrument sterilisation/autoclave, monitoring of vital signs, surgical microscope, cauterisation equipment, adjustable lighting, medications, surgical instruments and all and sundry consumables. In addition to standard welfare checks, the CRO should have the necessary expertise and equipment to perform tonometry, direct/indirect ophthalmoscopy, slit lamp, blood draws and plasma isolation, tissue extraction, fixation, processing and histological scoring. Tenderers must provide the supporting documentation specified above without delay when requested by the Contracting Authority.