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études cliniques microbiologique Cebiphar

Veterinary clinical studies

CEBIPHAR, as a clinical veterinary CRO, provides you with a department dedicated to the management of field studies on production and companion animals in compliance with GCP

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Customized support

CEBIPHAR can fit your needs

CEBIPHAR offers a wide range of services for clinical field trials related to the development of pharmaceutical specialties or vaccines, zootechnical products and animal feed.

Efficiency studies (for registration dossier or in a post-marketing context)
Tolerance studies
Palatability studies (for pharmaceutical specialties, food supplements, additives, etc.)
Microbiological studies: collection of field strains in the field, MIC, strain bank

Consultancy and support provided within the framework of these studies:

Development strategy for veterinary pharmaceuticals
Study design: determination of sample size, blind study setup, randomization, choice of control product
Writing of protocols
Preparation of clinical observation notebooks (CRFs)
Clinical trial declaration to the authorities
Procedures for importing drugs for clinical trials
Selection of investigators and clinical sites
Training of investigators and co-investigators
Clinical study monitoring, including site visits
Management of central laboratories (Bioanalysis CROs)
Pharmacovigilance under study (management of adverse events)
Data collection and quality control (data management)
Statistical analysis, interpretation of results
Writing of the report

CEBIPHAR is able to distribute products for veterinary clinical trials in accordance with GMP (ANSES):

Import and receipt of products
Storage under controlled conditions
Supply of authorized control products
Distribution, collection, monitoring and destruction of test products

Our Quality Assurance department is involved at every stage of GCP studies: audit of the protocol, raw data and the report.

Interactions process

Our approach

Flexibility

Study design in line with the product development strategy

Partnership

Selection and training of investigators

Expertise

Statistical analysis of the results

Regulatory support

Dossier audit, bibliography, writing of parts III and IV

CEBIPHAR provides you with an extensive network of investigators, with the flexibility of a small-sized CRO.