VETERINARY CLINICAL
TRIALS
One of the key aspects in the development of a veterinary pharmaceutical product or vaccine is the evaluation of its safety and efficacy during Clinical Trials.
To date, many veterinary products have been successfully registered (centralised procedure, decentralised procedure, mutual recognition, etc.) and authorised in Europe based on high quality data generated during Clinical Trials conducted by ONDAX Scientific.
This success contributes to making ONDAX Scientific one of the leading European companies specialising in the design and conduct of Clinical Trials for animal health products in the veterinary market.
Clinical Trials in compliance with Good Clinical Practice (VICH-GCP)
We consider ourselves proven specialists in multicentre European Veterinary Clinical Trials, and respond to the individual client (Sponsor) requirements enabling efficient product registration. To achieve these objectives, our highly skilled personnel offer extensive experience in the clinical development of pharmaceutical products and vaccines for both pets (companion animals) and food-producing (farm) animals, in compliance with Good Clinical Practice (VICH-GCP).
The main Clinical Trial related services we provide include:
- Clinical Trial design
- Study Protocol development
- CRFs design and preparation of study documentation
- Application for Clinical Trial permits and licences from the Regulatory Authorities
- Selecting Investigators, Researchers and suitable sites for the conduct of studies
- Training Investigators and associated study personnel
- Setting up Clinical Trials
- Monitoring study sites
- Follow-up, quality control and tracking of enrolled cases
- Pharmacovigilance
- Data Management
- Statistical analysis
- Management of investigational veterinary products
- Selecting and monitoring diagnostic laboratories
- Producing interim status reports
- Final Study Report
- Quality Assurance
ONDAX Scientific has many years experience conducting numerous Veterinary Clinical Trials in a wide range of animal diseases. If you would like to know more about the therapeutic areas in which we have extensive experience in the conduct of Veterinary Clinical Trials, please visit section: Therapeutic Areas
Other Animal Health Trials
The majority of the Veterinary Clinical Trials conducted by ONDAX Scientific are performed in compliance with Good Clinical Practice (VICH-GCP) guidelines with the objective of successfully registering a new pharmaceutical molecule, vaccine or new product claim. In addition, we also perform other types of animal health studies including:
- Prescription Diet Trials
- Post-registration Trials
- Palatability Trials
- Epidemiological studies
- Market surveys for new products/claims
- Pilot Clinical Trials (Go/No Go Decision)
Data Management
The management of the data collected (data capture) and the statistical analysis of the results are key functions in the conduct of Clinical Trials. If you require more information on the activities and services offered by the Data Management team within ONDAX Scientific please visit section: Data Management
Quality Assurance (QA)
We believe that the assurance of quality is a fundamental component in the conduct of Clinical Trials. The key role of our Quality Assurance Department is to ensure all the activities and services conducted on behalf of our clients are performed to the highest quality standards. If you require more information on the activities and services offered by our Quality Assurance department within ONDAX Scientific, please refer to section: Quality Assurance.
If you wish to receive additional information on a specific Therapeutic area or would like to discuss a specific Clinical Trial please do not hesitate to contact us
