Industry Provider Profiles
Java Clinical Research ltd
Company Type Services
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.
Established in 1999 Java Clinical Research Ltd is an Irish Contract Research Organisation (CRO) located in Dublin, Ireland and affiliated with two of Ireland’s largest medical universities, University College Dublin (UCD) and The Royal College of Surgeons in Ireland (RCSI).
We are specialists in providing a complete clinical trial service to the pharmaceutical, biotechnology and medical device industries. The company is led by research professionals with extensive experience in both early and late phase studies in a wide range of therapeutic areas from single centre intensive studies, to international multicentre trials. Java’s unique area of expertise under the guidance of our founding Director, Professor Desmond Fitzgerald, is the application of complex laboratory procedures to address particular questions of interest in early stage clinical research.
Our two core services are:
Clinical Trial Management Services
Drug Development Consultancy Services
Java is an authority on clinical research in Ireland, offering strategic advice on the clinical trial approval process. Our comprehensive range of services encompasses project management, monitoring, regulatory support, statistics as well as full study management. Studies may be conducted to Java’s SOPs or to the sponsor’s procedures. We have long-standing collaborations with experienced Irish Investigators. This enables us to ensure that clients benefit from quick feasibility assessments and can be assured of the local service and expertise they need to achieve overall project goals.
- Project Management
- Clinical Monitoring
- Investigator Selection
- Ethics Committee Applications
- Competent Authority Submissions
- Protocol Writing
- SOP writing
- Investigator-Led Studies
- ICH-GCP Training
- ICH-GCP Audits
We develop procedures used in academic research and apply them in clinical studies. Java’s scientific staff have experience in a range of assays to analyse biomarkers in difficult samples. By implementing complex procedures in a clinical trial, we combine our expertise to help clients achieve their scientific goals. We have particular expertise in the acquisition and analysis of non-standard samples for proteomic or transcriptomic biomarkers, and in trials requiring assessments of platelet function or inflammatory markers. Examples of our work include:
Custom sampling for biomarker analysis in cell populations.
We have developed methods for clients to reliably sample cells in whole blood for proteomic and transcriptional analysis. In particular, we have isolated platelets from whole blood and seen very consistent protein and RNA profiles in healthy volunteers. Based on the client’s need, we will develop sample processing procedures for the cells of interest, using differential centrifugation, magnetic separation, etc, and train phase I and II sites to take the blood and process as required.
Working in collaboration with experts in Core facilities of academic institutions, we perform biomarker analysis in ‘omic’ samples, including proteomic analysis (with the latest high-speed, high resolution Orbitrap instruments), RNASeq (on the Illumina platform) and miRNA analysis (using the Applied Biosystems TaqMan system). We work with technology specialists to customise the sample processing and analysis procedures, taking into account sample quantity, quality and complexity, while ensuring that appropriate standards of consistency, documentation and regulatory oversight are met. In addition, we also have established methods for the analysis of thromboxanes, eicosanoids and other biochemical markers in blood, urine and other clinical trial samples.
Platelet function testing.
Java has considerable experience in platelet function testing at all stages of clinical research. We customise assays such as light transmission aggregation or flow cytometry to the requirements of the study. As well as common drug classes such as GP IIb/IIIa or P2Y12 antagonists, we also have experience with agents such as PAR1 (thrombin receptor) antagonists. As well as pharmacodynamic testing in studies of antiplatelet agents, we also test stimulation or inhibition of platelet function as a side effect of drugs with other indications. Platelet function testing is performed by Java in preclinical testing, and we also train and support sites (including completely lab-naive operators) in phases I-III to run testing in studies.
We have formalised alliances with networks of European CROs comprising of companies similar in size to Java. These alliances have proven very successful for Java’s clients who wish to run pan-European projects. Through such networks Java are truly a gateway to Europe, providing maximum flexibility and optimal, cost-effective, trial management at local level.
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.
Java Clinical Research ltd
Fitzwilliam Business Centre
26 Upper Pembroke Street
+ 353 1 6373903
+353 1 6373907 (fax)
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