HUMAN CLINICAL
TRIALS

ONDAX Scientific can provide our clients with all the fundamental components to perform their Clinical Trials in the most professional and efficient manner whilst ensuring the highest quality standards.

Our specialist personnel have a broad range of experience in the clinical development of human pharmaceutical products. We offer collaborative development services for Clinical Trials, Observational studies and Epidemiological studies.

Management and development of studies (Clinical Trials, Observational Studies, Epidemiological Studies):

We provide the following activities related to the conduct of Human Clinical Trials:

• Protocol design
• Case Report Forms (CRF) design
• AEM Authorisation (regulatory test permit approvals)
• CEIC Authorisation (ethics committee approvals)
• Regional authority approvals
• Selection of study centres and researchers/investigators
• Management of contracts with researchers/investigators and study centres
• Monitoring
• Final study report development and completion
• Publications

External regional monitors (regional outsourcing)

Although we perform monitoring functions in many geographical areas, our strategic location as the only CRO based in North Western Spain enables us to provide Regional Monitoring Services in this area.

Our highly qualified personnel (monitors, project managers, etc.) are available to manage and monitor study centres in Northern Spain (La Rioja, Navarra, Basque Country, Cantabria, Aragon, etc.).

Pharmaceutical companies are increasingly aware of the potential advantages that regional outsourcing can offer. These benefits include:

• A rapid response given the close proximity of the study centres to our local offices we can rapidly resolve any issues that may arise during the course of a study.
• Flexibility, responsiveness and efficiency related to a regional approach.
• Economic advantages: cost savings in terms of reduced travelling time and related expenses etc.
• Extensive local knowledge of the hospitals, investigators, researchers and related personnel.
• Knowledge of local regulatory requirements and regional ethics committees.

ONDAX Scientific personnel have conducted numerous Clinical Studies in wide range of therapeutic fields. If you would like further information on our Clinical Trial experience in diverse therapeutic disciplines, please visit section: Therapeutic Areas

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