Services

Clinical

CLINICAL STUDIES FOR LOCAL AND EU REGISTRATION OF NEW VETERINARY PRODUCTS

The management of well-designed, controlled and animal welfare complying, GCPV clinical studies is the base for a fast and successful approval of the registration dossier to achieve marketing authorization of new veterinary products.

CLINICAL STUDY SERVICES

POST-AUTHORIZATION CLINICAL TRIALS

Clinical skill and internal procedures allow the collection of high quality and large scale controlled data to provide the Sponsors supplementary information on efficacy, safety and production performances of registered medicinal products for internal use or scientific publishing.

Our experience

Epidemiology and microbiology

EPIDEMIOLOGICAL STUDIES

The understanding of frequency, distribution, and time dynamics of different diseases allows the adoption of short to long term strategies for the placement, use and marketing of veterinary products. Access to a wide group of specialised veterinarian, farms, laboratories and the collaboration with qualified epidemiologists allows us to conduct large scale surveys on the major veterinary diseases in all species.

MICROBIOLOGICAL STUDIES

The knowledge of susceptibility and resistance to new veterinary antimicrobial is a requirement to grant marketing authorisation. With a portfolio of field pathogen isolates responding to EMEA/CVMP/627/01 requirements and in collaboration with NCCLS complying laboratories we are able to conduct microbiological studies on efficacy, sensitivity, resistance and genetics of the principal veterinary pathogens.

Nutrition

NUTRITION AND PALATABILITY STUDIES

Palatability studies on companion animals in own domestic environment. Nutritional studies in large animals (beef, dairy cattle and pigs). Conducted in selected equipped farms, with different management, automation, computerisation and production systems, allows the quantitative evaluation of the impact of food and additives on production performances.

Multimedia and communication

MULTIMEDIA

Images and new media platforms play a central role in education and promotion of industrial products in animal health. Arcoblu Multimedia Unit merges the technical and scientific background with the effectiveness of the new communication media to produce educational, corporate, advertising video and multimedia products, which effectively deliver the correct information to the chosen target.

COMMUNICATION

Arcoblu provides a number of services in support of Animal Health companies communication activities requiring specific technical and scientific skills together with a deep knowledge of the in-field condition.
Personnel training, bibliographical research, production of technical manuals, scientific publications, presentations, technical/scientific translations and technical brochures.

Quality

A Quality Assurance system is an essential ingredient of the process leading new medicinal products to the market and guarantees the production of reliable data in clinical research. All the key points of the management and running of our studies are compliant with guidelines and regulatory requirements and are implemented in our internal Quality System. Internal procedures (SOPs) designed and developed by Arcoblu QA Unit and a robust Audit System guarantee that each commission is performed at the required standard.

Regulatory

The understanding of the regulatory environment and the application of the legal requirements necessary to obtain marketing authorisation of new veterinary products is a challenging and time/resources consuming commitment. Our Regulatory Unit supports Animal Health companies in the approval for study conduction and to plan and achieve marketing authorization process through, among others, dossier setup and evaluation, submission to Regulatory Authorities, identification of qualified experts and expert report writing.