Java Services

Java offers international coverage across all therapeutic areas through our partnership with European CRO networks. These networks offer unified national expertise under the umbrella of common SOPs and a central project management.

Our services include:

Study management and monitoring

• Clinical development & planning
• Study protocol & CRF design
• Investigator selection
• Patient recruitment
• Project management
• Monitoring to GCP-ICH standards, European and FDA regulatory requirements and company procedures
• Clinical study reports

Regulatory Support

• Regulatory submissions
• Ethics committee applications

Provision of ICH-GCP training to CRAs and site personnel

Investigational site audits for adherence to ICH GCP, International and Local Regulatory requirements

Provision of expert consultancy advice & support across all phases of the clinical trial programme

Our affiliation with University College Dublin, and our established relationship with investigators who have participated in previous Java studies, gives us direct access to a large investigator network and large patient databases. These investigators are experienced research professionals with highly trained staff and excellent facilities. These high quality resources enable us to carry out quick feasibility assessments and will allow us to provide sponsor companies on advice on realistic timelines and the milestones achievable for their project.

Java quality assurance procedures

Java is committed to ensuring that all studies are conducted to the highest quality standards. The responsibility of the QA function within Java is to ensure that all clinical research activities conducted by Java comply with the EU CT and GCP Directives, GCP/ICH and all national and international regulatory requirements.

Click here to see a list of Java’s clinical trial services.