| Activities |
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| Clinical trials in Veterinary Medicine to support EU marketing authorization and Post Marketing trials |
| CLINICAL TRIAL MANAGEMENT |
| Preliminary phase |
- Meeting with the sponsor and feasability study based on technical schedule or draft protocol
- Budget approval and planning of activities
- Contact with the personnel involved in the study, assessement of site requirements, availability of personnel, Pre Study Visits, Site evaluation
- Protocol approval
- Communication/request to relevant authorities for authorization to conduct clinical trials
- Training of personnel (Investigators, Laboratories, Owners/Farmers) on GCPV, study subject and protocol procedures
- Preparation of administrative documentation and data collection files
- Management of experimental drugs (storage, delivery and documentation)
- Management of materials and equipment necessary for the conduction of the study
- Delivery of study materials to study facilities
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| In vivo phase |
- Animal recruitment
- Field Monitoring and Investigator support
- 24/24 h Monitor availability
- Report of SADR/AE
- Track of communications between study partecipants
- Management of functional database for monitoring purposes
- Sponsor Interim Reports
- On site Validation of Raw Data and Administrative Documents
- Study termination procedures
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| Study completion |
- On site study completion procedures
- Validation of Raw Data and Administrative Documents
- Assembling of Study Master File
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| Report and communications |
- Interim and final Trial report writing
- Meetings with the Sponsor
- Conference presentations
- Scientific papers writing
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| RESOURCES |
| Investigators |
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Companion animals:
51 Veterinary clinics/practitioners experienced in GCPV/VICH Clinical Trials |
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Large animals:
14 Veterinary clinics/practitioners with personnel experienced in GCPV/VICH Clinical Trials (Bovine, Swine, Horse, Sheep, Goat, Poultry) |
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| Animals |
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Herds |
Study Fields |
| Dairy Cows |
1300 |
Mastitis |
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800 pasture |
Metabolic diseases |
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Reproduction |
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Foot lesions |
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Surgery |
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Respiratory diseases |
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Parasites |
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| Beef Cattle |
6500 |
Nutrition |
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| Calves |
3100 |
Enteric diseases |
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Respiratory diseases |
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Endo-EctoParasites |
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| Horse |
150 racing |
Reproduction |
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80 meat production |
Parasites |
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Surgery |
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Enteric diseases |
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Respiratory diseases |
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| Swine |
700 female (Open) |
Enteric diseases |
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700 (Close) |
Parasites |
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Nutrition |
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Reproduction |
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Metabolic diseases |
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Respiratory diseases |
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| Sheep |
1000 on pasture |
Metabolic diseases |
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300 farm |
Reproduction |
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Foot lesions |
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| Goat |
800 various manag. |
Parasites |
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Enteric diseases |
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Respiratory diseases |
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| COMPANY EXPERIENCE |
| Disease |
Species |
| Cheyletiella infestation |
Dog |
| Gastro-enteric disease |
Dog, Bovine, Swine |
| FAD |
Dog, Cat |
| Flea treatment, prevention |
Dog, Cat |
| Gastrointestinal Nematodes |
Dog, Cat, Bovine, Horse |
| Heartworm disease |
Dog, Cat |
| Lameness, Foot Lesion Prevention |
Bovine |
| Louse infestatation |
Dog, Cat, Bovine |
| Mastitis |
Bovine |
| Metabolic disease |
Bovine |
| MIC determination BRD |
Bovine |
| MIC determination SRD |
Swine |
| Otodectic mange |
Dog, Cat |
| Respiratory disease |
Bovine, Swine |
| Sarcoptic mange |
Dog |
| Tick infestation |
Dog |
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| Compounds |
Species |
| Antibiotics |
Dog, Cat, Cattle, Cow, Swine, Poultry, MIC |
| Antiparasitics |
Dog, Cat, Cattle, Cow, Swine, Horse, Poultry |
| Feed |
Dog, Cat, Cattle, Swine, Poultry |
| Food Additives |
Cattle, Swine, Poultry |
| Metabolism |
Cow |
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| REGULATORY REQUIREMENTS |
| Clinical studies are conducted in accordance with: |
- International cooperation on harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), GL9 - Good Clinical Practice (GCP) (June 2000)
- Gazzetta Ufficiale della Repubblica Italiana 10/12/96, Ministero della Sanitą 25 settembre 1996 - Buone pratiche di sperimentazione clinica, negli animali, dei medicinali veterinari.
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