Industry Provider Profiles
Java Clinical Research ltd

• Mission Statement
• Company Overview
• Major Services
• Clinical Research Experience
• Global Capabilities
• Local Collaborators
• Specialist Platelet Pharmacology Service
• Contact Company

Mission Statement

Supported by sophisticated resources, Java Clinical Research interfaces with the pharmaceutical industry and Irish physicians, paving the way towards a wide range of successful clinical trials.

Company Overview

Based in Dublin, Java Clinical Research is an Irish Contract Research Organisation specialising in providing a complete clinical trial service to the pharmaceutical industry. Working as a development partner with clients throughout phases II-IV, we help them to take their new products all the way from research right through to the market. The company is led by research professionals well versed in both early and late phase studies.

We commit ourselves unreservedly to the success of each client programme. Every effort is made from the outset to ensure we have an implicit understanding of the sponsor’s goals and cultures as well as the specific requirements of the product concerned. This enables us to tailor our bidding, working and reporting systems exactly to the detailed needs of the programme.

Major Services

Java Clinical Research provides a complete clinical trial service to the pharmaceutical industry. These Services include:

• Protocol Writing
• CRF Design
• Investigator Selection
• Project Management
• Monitoring
• Ethics Applications
• Regulatory Support
• Report Writing
• SOP writing
• Management of Investigator-Led Trials
• GCP Training
• GCP Audits

Clinical Research Experience

Our team of project managers have over 10 years’ experience in both pharmaceutical and CRO industries, so they understand the complexities of running a clinical study. A dedicated project manager acts as a single point of contact throughout the duration of the study to ensure the success of each client programme.

Global Capabilities

We can offer international coverage through our partnerships with established experienced local CRO’s situated across Europe and North America. Through this network we can offer our clients a full range of clinical research services for both pharmaceutical and biotechnology clinical development programmes.

Local Collaborators

We have established a network of Irish Investigators who are very keen to collaborate with Java Clinical Research ltd. These Investigators are experienced research professionals with highly trained research staff and excellent facilities. They enable us to offer our clients access to large patient populations across a wide range of therapeutic diseases. Through this collaboration our clients can be assured of local service and expertise to enable them to successfully achieve overall project goals.

Specialist Platelet Pharmacology Service

Our area of unique expertise is in the support of platelet aggregation and other assays of platelet function in clinical trials. Our support maximises the quality and usefulness of this crucial data in the drug development process. We offer three main services:

• Quality control
  Provision of training, support and data review to assist the performance of platelet function assays at clinical trial sites. Most trial sites are not familiar with these assays, and data quality may suffer in multicentre trials. However, platelet function studies provide vital pharmacodynamic and population response data. As a CRO specialising in this area, our review and support services reduce errors and identify remaining artifactual results. This yields more reliable platelet function data, allowing better decision making as the drug progresses through the clinical development process.
• Tailored studies
  Design, management and interpretation of intensive substudies of platelet function. Such studies may address particular areas of concern, or provide evidence to differentiate a compound from competitors. Aspects that may be studied include pharmacokinetics; pharmacodynamics and signalling; pharmacogenomics and other sources of variability. With our involvement these studies will address crucial uncertainties in areas such as safety, mechanism of action, metabolism or population variation.
• Consultancy
  Expert consultancy and advice on all aspects of platelet pharmacology, clinical trial design, data analysis and drug development

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